Methods, means and modes. The main differences between technical characteristics, state and industry standards Application of OST

Pipeline insulation

State standard

GOST - state standard - is being developed for products of inter-industry significance.

Unlike technical specifications, GOST requirements are developed not by the manufacturer, but by state industry structures, approved at the highest level by the Interstate Council for Standardization, Metrology and Certification.

Each GOST undergoes serious tests and inspections in certified laboratories, is evaluated by industry scientists, undergoes interdepartmental approvals, and only after that is allowed for publication.

Many institutes, enterprises, and experts are involved in the creation and approval of GOST. GOSTs are approved by the Federal Agency for Technical Regulation and Metrology (abbreviated name in 2004-2010 - Rostekhregulirovanie; since June 2010 - Rosstandart) - a federal executive body that carries out the functions of providing public services, managing state property in the field of technical regulation and metrology. It is administered by the Ministry of Industry and Trade of the Russian Federation. In other countries (CIS) - similarly.

Examples:

GOST 17375-2001 “Seamless welded pipeline parts made of carbon and low-alloy steel. Steeply curved bends, type 3D (R ≈ 1.5 DN). Design"
GOST 30753-2001 “Seamless welded pipeline parts made of carbon and low-alloy steel. Steeply curved bends, type 2D (R = DN). Design"
GOST 24950-81 “Bent bends and curved inserts at turns of the linear part of steel main pipelines. Technical conditions".
GOST 17378-2001 “Seamless welded pipeline parts made of carbon and low-alloy steel. Transitions. Design"
GOST 22826-83 “Assembly units and parts of pipelines. Transitions to Ru St. 10 to 100 MPa (over 100 to 1000 kgf/cm²). Design and dimensions"
GOST 17376-2001 “Seamless welded pipeline parts made of carbon and low-alloy steel. Tees. Design"
GOST 22822-83 “Assembly units and parts of pipelines. Transition tees to Ru St. 10 to 100 MPa (over 100 to 1000 kgf/cm²). Design and dimensions"
GOST 17379-2001 “Seamless welded pipeline parts made of carbon and low-alloy steel. Elliptical plugs. Design".
GOST 6533-78 “Elliptical flanged steel bottoms for vessels, apparatus and boilers. Basic dimensions."

Specifications

TU - technical specifications - developed by the manufacturing enterprise and is approved by the line ministry with minimal formalities. Therefore, specifications can be softer compared to GOST, or they can be more stringent when the standard is outdated and does not meet the requirements of a particular production, for example, in terms of manufacturing accuracy, the amount of impurities, etc. Enterprises, in order to avoid unnecessary costs, often develop their own specifications to certify their products.

GOST establishes technical requirements for products, safety requirements, methods of analysis, scope and methods of application. GOST requirements are mandatory for compliance by all government authorities and business entities. If GOST is at the very top of the pyramid of standards, then TU is at the very bottom: technical conditions are for the most part developed by manufacturers independently, based on their own ideas about how this or that product should be made and what properties it should have.

Examples:

TU 1469-001-34929762-2004 “Pipeline connecting parts. Technical conditions".
TU 1469-013-13799654-2008 “Connecting parts for field and process gas and oil pipelines for operating pressure up to 31.4 MPa (320 kgf/cm²). Technical conditions".
TU 3647-001-37941826-2012 “Welded steel connecting parts of steel grades 20 and 09G2S for operation on pipelines with a nominal pressure of up to 100 MPa. Technical conditions".
TU 3647-095-00148139-2000 “Connection parts for pipelines. Technical conditions".
TU 1469-006-00153229-2009 “Connection parts for main pipelines for operating pressure up to 11.8 MPa and field pipelines for operating pressure up to 16 MPa.”

Industry standard

OST - industry standard - is developed for products of industry importance.

Industry standard (OST) - established for those types of products, norms, rules, requirements, concepts and designations, the regulation of which is necessary to ensure the quality of products in a given industry.

The objects of industry standardization, in particular, can be certain types of products of limited use, technological equipment and tools intended for use in a given area, raw materials, materials, semi-finished products for intra-industry use, certain types of consumer goods. Also, the objects may be technical standards and standard technological processes specific to a given industry, norms, requirements and methods in the field of design organization; production and operation of industrial products and consumer goods.

Industry standards are approved by the ministry (department), which is the head (leading) in the production of this type of product. The degree of mandatory compliance with the requirements of an industry standard is determined by the enterprise that applies it, or by agreement between the manufacturer and the consumer. Monitoring the implementation of mandatory requirements is organized by the agency that adopted this standard.

Designation of the industry standard in accordance with GOST R 1.5-92 “State standardization system of the Russian Federation. General requirements for the construction, presentation, design and content of standards” contains the OST index; symbol of the ministry (department) that issued the standard; registration number assigned in the manner established by the ministry (department) in agreement with the State Standard of Russia; and also through an en dash after the registration number, two (for OST adopted before 2000) or four (for OST adopted after 2000) the last digits of the year of adoption of the standard. OST 34-10-764-97 “Parts and assembly units pipelines of thermal power plants at Prab up to 2.2 MPa, t 425 °C. Transitional tees."
OST 36-24-77 “Parts of pipelines DN 500-1400 mm, welded from carbon steel to Ru up to 2.45 MPa. Welded tees."
GTU - general technical conditions - establish requirements for a group of homogeneous products.
SNiP - building codes and regulations

"On the introduction of the industry standard OST 42-21-2-85 "Sterilization and disinfection of medical devices. Methods, means and modes" (together with OST 42-21-2-85)

Revision dated June 10, 1985 - Valid

ORDER
dated June 10, 1985 N 770

ON THE INTRODUCTION OF THE INDUSTRY STANDARD OST 42-21-2-85 "STERILIZATION AND DISINFECTION OF MEDICAL DEVICES. METHODS, MEANS AND REGIMES"

In order to establish uniform methods, means and regimes for sterilization and disinfection of medical devices, I order:

1. Introduce industry standard OST 42-21-2-85 “Sterilization and disinfection of medical devices. Methods, means and regimes” from January 1, 1986.

3. Control over the implementation of this Order shall be entrusted to the Department for the Introduction of New Medicines and Medical Equipment (Comrade E.A. Babayan) and the Main Directorate of Quarantine Infections (Comrade V.P. Sergiev).

First Deputy Minister
health care of the USSR
O.P.SHCHEPIN

I CONFIRM:
First Deputy Minister
health care of the USSR
O.P.SHCHEPIN
June 7, 1985

AGREED:
Ministry
health care of the USSR
Head of Department
on the introduction of new
medicines
and medical equipment
E.A.BABAYAN
May 5, 1985

Boss
Main Directorate
quarantine infections
V.P.SERGIEV

APPROVAL SHEET

Director of VNIIDiS
P.P.LYARSKY

Hand. sterilization department
N.V.RAMKOVA

Hand. disinfection department
Y.F.SOKOLOVA

Art. Researcher
A.N.IOIRISH

CO-PERFORMERS:
Director of VNIIIMT
B.I.LEONOV

Head standardization department
V.Ya.ZELDICH

Head sector
A.I.TERESHENKOV

Art. engineer
N.A. RYBCHINSKAYA

MINISTRY OF HEALTH OF THE USSR

INDUSTRY STANDARD
STERILIZATION AND DISINFECTION OF MEDICAL DEVICES METHODS, MEANS AND MODES OST 42-21-2-85

Official publication

DEVELOPED by the All-Union Scientific Research Institute of Disinfection and Sterilization (VNIIDiS)

Director of the Institute P.P. Lyarsky

Deputy Director Kruchenok T.B.

Head Department of Sterilization N.V. Ramkova

Head Disinfection Department N.F. Sokolova

Performers: Abramova I.M., Guterman I.A., Evtikova L.V., Ioirish A.N., Kopylova L.S., Troshin K.A., Yuzbashev V.G.

All-Union Scientific Research and Testing Institute of Medical Equipment (VNIIIMT)

Director of the Institute Leonov B.I.

Performers: Rybchinskaya N.A., Tereshenkov A.I.

AGREED:

Directorate for the Introduction of New Medicines into Medical Equipment of the USSR Ministry of Health

Main Directorate of Quarantine Infections of the USSR Ministry of Health

Head of Department Sergiev V.P.

PREPARED FOR APPROVAL

Directorate for the Introduction of New Medicines and Medical Equipment of the USSR Ministry of Health

Head of Department Babayan E.A.

APPROVED

Ministry of Health of the USSR

Deputy Minister

PUT INTO EFFECT

By order of the USSR Ministry of Health N 770 of June 10, 1985

Assigned to the All-Union Scientific Research Institute of Disinfection and Sterilization (VNIIDiS)

UDC 614.48 Group R 08

INDUSTRY STANDARD

STERILIZATION AND DISINFECTION OF MEDICAL DEVICES

METHODS, MEANS AND MODES

Instead of OST 42-2-2-77

Failure to comply with the standard is punishable by law

This standard applies to medical devices that are subjected to sterilization and (or) disinfection during use.

The standard is mandatory for institutions operating medical devices, as well as for organizations and enterprises developing and manufacturing these products.

The standard does not apply to medicines and their packaging, to products produced by industry as sterile, to products made from textile materials (in terms of disinfection), patient care items, and medical furniture.

The standard establishes methods, means and modes of pre-sterilization cleaning, sterilization and disinfection.

Basic concepts from the field of pre-sterilization cleaning, sterilization and disinfection according to GOST 25375-82 (ST SEV 3188-81).

The list of regulatory and technical documents for chemical reagents and auxiliary materials is given in the reference Appendix 1 to this standard.

The list of instructional and methodological documents of the USSR Ministry of Health on issues of sterilization and disinfection is given in the reference Appendix 2 to this standard.

1. General Provisions

1.1. The methods, means and modes of pre-sterilization cleaning, sterilization and disinfection established in this standard are equivalent in effectiveness for each type of treatment.

Note. Preference should be given to thermal sterilization methods (steam and air).

1.2. Based on the provisions of this standard, instructions should be developed establishing methods, means and modes of pre-sterilization cleaning, sterilization and disinfection in relation to specific products or groups of products, taking into account their purpose and design features.

1.3. When developing products, a method, means and mode must be selected based on the resistance of the products to means of pre-sterilization cleaning, sterilization and disinfection, depending on the material, the degree of surface treatment, and design.

The selected methods, means and modes should not cause changes in the appearance, performance and other characteristics of the product, and the processed products should not have a toxic effect.

1.4. Requirements for the resistance of products to means of pre-sterilization cleaning, sterilization and disinfection must be standardized in technical specifications (medical and technical requirements) for the development of new products, technical specifications, standards, and also specified in operational documentation and must be monitored at the stage of development and manufacture of the product.

In technical specifications and standards for mass-produced products, the requirement for product resistance to pre-sterilization cleaning and a specific method of sterilization or disinfection should be standardized taking into account the provisions of this standard based on the results of preliminary tests.

1.5. During the operation of products, pre-sterilization cleaning, sterilization and (or) disinfection must be carried out in accordance with this standard and the instructions of the USSR Ministry of Health, developed on the basis of this standard, establishing the procedure for pre-sterilization cleaning, sterilization, disinfection of specific types of products, as well as operational documentation.

1.6. The provisions of the technical documentation (including operational) of the pre-sterilization cleaning, sterilization and disinfection must comply with this standard, the instructions of the USSR Ministry of Health, and in the absence of these instructions for certain types of products must be agreed with the USSR Ministry of Health.

1.7. When carrying out pre-sterilization cleaning, sterilization and disinfection by chemical methods (except for gas sterilization), disinfection by boiling, it is allowed to use inhibitors and other additives that help reduce corrosion, approved by the USSR Ministry of Health and not reducing the effectiveness of pre-sterilization cleaning, sterilization and disinfection.

1.8. Sterility control should be carried out by bacteriological laboratories of sanitary-epidemiological stations and medical institutions in accordance with the instructions of the USSR Ministry of Health.

1.9. Control of the operation of sterilizers is carried out by disinfection stations and disinfection departments (departments) of sanitary and epidemiological stations in accordance with the instructions of the USSR Ministry of Health.

1.10. Quality control of pre-sterilization cleaning and disinfection should be carried out by medical institutions, sanitary-epidemiological and disinfection stations in accordance with the instructions of the USSR Ministry of Health.

2. Pre-sterilization cleaning

2.1. All products must undergo pre-sterilization cleaning before they are sterilized in order to remove protein, fat and mechanical contaminants, as well as medications.

2.2. Detachable products must undergo pre-sterilization cleaning when disassembled.

2.3. Pre-sterilization cleaning must be carried out manually or mechanized (using special equipment).

2.4. Mechanized pre-sterilization cleaning should be carried out by jet, rotational methods, brushing or using ultrasound using surfactants according to clause 2.8 of this standard and other additives.

The method of performing mechanized cleaning must comply with the operating instructions supplied with the equipment.

Note. Rubbing rubber products is not allowed.

2.5. Pre-sterilization cleaning manually should be carried out in the sequence in accordance with table. 1.

2.6. When using a washing solution containing 0.5% hydrogen peroxide and 0.5% synthetic Lotus detergent, a corrosion inhibitor is used - 0.14% sodium oleate.

2.7. At the end of the work shift, the equipment must be cleaned mechanically by washing with detergents.

2.8. The cleaning solution must include components in accordance with table. 2.

2.9. Instruments may be subject to corrosion during operation, pre-sterilization cleaning, and sterilization. Tools with visible stains of corrosion, as well as with the presence of an oxide film, are chemically cleaned no more than 1 - 2 times a quarter.

3. Sterilization

3.1. All products that come into contact with a wounded surface, come into contact with blood or injectable drugs, and certain types of medical instruments that, during operation, come into contact with the mucous membrane and can cause damage to it, must be sterilized.

3.2. Sterilization should be carried out by one of the methods given in table. 4 - 9.

4. Disinfection

4.1. All products that do not come into contact with a wounded surface, blood or injectable drugs must be disinfected.

Products used during purulent operations or surgical manipulations in an infectious patient are disinfected before pre-sterilization cleaning and sterilization. In addition, medical products are subject to disinfection after operations, injections, etc., for persons who have had hepatitis B or hepatitis with an unspecified diagnosis (viral hepatitis), as well as for those who are carriers of the HB antigen.

Disinfection should be carried out using one of the methods indicated in the table. 10.

Table 1

PRE-STERILIZATION CLEANING

Cleaning processes	Cleaning mode				Equipment used
			Holding time min.
	nominal meaning	limit. deviation	nominal meaning	limit. deviation
Immersion of blood-contaminated instruments in a corrosion inhibitor solution (1% sodium benzoate solution) immediately after use during surgery or manipulation	at least 18		60	+/- 5	Basin, tank
Rinsing with running water			0,5	+0,1	Bath, sink
Soaking in a washing solution (clause 2.8) with the product completely immersed	50 <*>	+5	15,0	+1,0	Cistern, bathtub, sink
Washing each product in a cleaning solution (clause 2.8) using a brush or cotton gauze swab			0,5	+0,1
Rinsing under running water					Bathtub, sink with jet water supply
- when using the detergent "Biolot"			3,0
- when using the Progress detergent			5,0	+1,0
- when using detergents “Astra”, “Lotos”, “Aina”			10,0
Rinsing with distilled water or boiling in it			0,5 5,0	+0,1	Tank, disinfection boiler
Hot air drying	85	+2 -10	until it completely disappears. moisture		Drying cabinet

<*>The solution temperature is not maintained during the washing process.

Notes

1. If an instrument contaminated with blood can be washed under running water immediately after use during surgery or manipulation, it is not immersed in a solution of a corrosion inhibitor (sodium benzoate).

2. If necessary (duration of operations), the tool can be left immersed in a cleaning solution with a corrosion inhibitor for up to 7 hours.

3. The cleaning solution can be used until it becomes dirty (until a pink color appears, which indicates contamination of the solution with blood, which reduces the cleaning efficiency). A washing complex of hydrogen peroxide with synthetic detergents can be used within two days from the date of manufacture if the color of the solution has not changed. The unchanged solution can be heated up to 6 times; during the heating process, the concentration of hydrogen peroxide does not change.

4. The drying regime for endoscopes and products made of natural latex, as well as the requirements for immersing endoscopes in solutions should be set out in the operating instructions for these products.

table 2

PREPARATION OF WASHING SOLUTION

Name of components	Number of components for preparing 1 liter of cleaning solution	Applicability
Detergent "Biolot", g	3	Used for mechanized cleaning (jet method, roughening, ultrasound)
Drinking water, cubic meters cm	987
Detergent "Biolot", g	1,5
Drinking water, cubic meters cm	998,5
Detergent "Biolot", g	5	Used for manual cleaning
Drinking water, cubic meters cm	905
Hydrogen peroxide solution<*>, cubic cm	20	Used for mechanized cleaning (jet method, roughing, ultrasound) and manual cleaning
<**>, G	5
Drinking water<**>, cubic cm	975
Hydrogen peroxide solution<*>, cubic cm	4,5	Used for mechanized cleaning using the rotational method
Detergent preparation ("Progress", "Aina", "Astra", "Lotus")<**>, G	1,5	Used for mechanized cleaning using the rotational method
Drinking water<**>, cubic cm	994
Detergent "Lotos", g	5	Used for mechanized cleaning using ultrasound
Drinking water, cubic meters cm	905	Used for mechanized cleaning using ultrasound

<*>For pre-sterilization cleaning, it is allowed to use medical hydrogen peroxide, as well as technical grades A and B hydrogen peroxide.

<**>Organizations developing and manufacturing medical devices must use solutions of hydrogen peroxide with detergents when testing the resistance of products to pre-sterilization cleaning agents.

Table 3

CHEMICAL CLEANING OF STAINLESS STEEL SURGICAL INSTRUMENTS

Chemical cleaning processes	Cleaning mode				Equipment used
	Initial solution temperature, degrees C		Holding time min.
	nominal meaning	limit. deviation	nominal meaning	limit. deviation
Pre-rinse with running water			0,5	+/- 0,1	Bath, sink
Soaking in solution:	20,0	+/- 1,0	2,0	+1,0 <*>	Enameled, glass, polyethylene container with lid
acetic acid - 5 g (calculated to 100%) sodium chloride - 1 g			3,0	-/+ 1,0 <**>
distilled water - up to 100 cubic meters. cm			6,0	-/+ 2,0
Rinsing with running water			0,5	-/+ 0,1	Bath, sink
Drying					Sheet, diaper, towel

<*>For stainless steel scalpels.

<**>For instruments with an oxide film.

<***>For instruments with severe corrosion damage, it is recommended to additionally clean the damaged areas with a brush or a cotton-gauze swab.

Table 4

STEAM STERILIZATION METHOD (SATURATED WATER STEAM UNDER EXCESSIVE PRESSURE)

Sterilization mode							Applicability		Sterility retention period	Equipment used
Steam pressure in the sterilization chamber, MPa (kgf/sq. cm)		Operating temperature in sterilizer. chamber, deg.C		Sterilization holding time, min.
				with manual and semi-automatic management, no less	with automatic management
nominal meaning	maximum deviation
		nominal meaning	maximum deviation
					nominal meaning	maximum deviation
0,20 (2,0)	-/+ 0,02 (-/+ 0,2)	132	-/+ 2	20	20	+ 2	Recommended for products made of corrosion-resistant metal, glass, textile products, rubber	Sterilization is carried out in sterilization boxes without filters, or in double soft packaging made of calico,	The period of preservation of sterility of products sterilized in sterile boxes without filters, in double soft	Steam sterilizer
0,11 (1,1)	+0,02 (+0,2)	120	+2	45	45	+3	Recommended for products made of rubber, latex and certain polymer materials (high-density polyethylene, PVC plastic compounds)	parchment, unimpregnated sack paper, moisture-resistant sack paper, paper for packaging products on E-type machines	packaging made of calico or parchment, unimpregnated paper, moisture-resistant sack paper, paper for packaging products on E-type machines, equal to 3 days; in sterilization boxes with a filter - 20 days

Notes

1. Sterilization boxes are not packaging for storing sterilized products, but if the sterilized material is stored in the boxes for the time specified in the table, it can be used for its intended purpose.

2. Products made of corrosion-resistant metal according to OST 64-1-72-80 and OST 64-1-337-78.

Table 5

AIR STERILIZATION METHOD (DRY HOT AIR)

Sterilization mode				Applicability	Conditions for sterilization	Sterility retention period	Equipment used
		Holding time, min.
nominal meaning	prev deviation	nominal meaning	limit. deviation
180	+2 -10	60	+5	Recommended for metal, glass and silicone rubber products	Dry products are subjected to sterilization. Sterilization is carried out in packaging made of unimpregnated sack paper, moisture-resistant sack paper, paper for packaging products on E-type machines and kraft paper or without packaging (in open containers)	Products sterilized in unimpregnated sack paper and moisture-resistant sack paper, paper for product packaging on E-type machines can be stored for 3 days. Products sterilized without packaging must be used immediately after sterilization	Air sterilizer
160	-/+ 5	150

CHEMICAL STERILIZATION METHOD (SOLUTIONS OF CHEMICALS)

Sterilizing agent	Sterilization mode				Applicability	Conditions for sterilization	Equipment used
	Temperature deg.C		Holding time, min.
	nominal meaning	limit. deviation	nominal meaning	limit. deviation
Hydrogen peroxide, 6% solution<**>	at least 18		360	-/+ 5	Recommended for products made from	Sterilization should be carried out when	Closed glass containers,
	50 <*>	-/+ 2	180	-/+ 5	polymeric materials rubber, glass, corrosion-resistant metals	completely immersing the product in the solution for the duration of the sterilization exposure, after which the product must be washed with sterile water<****>. The shelf life of a sterilized product in a sterile container (sterilization box) lined with a sterile sheet is 3 days.	plastic or enamel coated (enamel without damage)
"Dezoxon-1" 1% solution<***>(based on peracetic acid)	at least 18		45	+5

<*>The solution temperature is not maintained during the sterilization process.

<**>The hydrogen peroxide solution can be used within 7 days from the date of preparation, provided it is stored in a closed container in a dark place. Further use of the solution can only be carried out if the content of active substances is controlled.

<***>The Dezoxon-1 solution can be used for one day.

<****>Organizations that develop and manufacture products may use non-sterile water when testing the resistance of products to sterilization agents.

Table 7

CHEMICAL STERILIZATION METHOD (GAS) STERILIZATION WITH A MIXTURE OF OB AND ETHYLENE OXIDE

Sterilizing agent	Sterilization mode								Applicability	Conditions for sterilization	Equipment used
	Gas dose			Operating temperature in sterilizer. chamber, degrees C		Relates. humidity, %	Holding time, min.
	mg/cu.m. dm	kgf/sq. cm	mmHg Art.
							nominal meaning	limit. deviation
				nominal meaning	limit. deviation
Mixture of OB (ethylene oxide with methyl bromide in a ratio of 1:2.5 by weight, respectively)	2000	0,75	549	35	+/- 5	Not less than 80	240	-/+ 5	For optics, pacemakers	Sterilization is carried out in a package of two layers of polyethylene film 0.06 - 0.2 mm thick, parchment, unimpregnated sack paper, moisture-resistant sack paper, paper for packaging products on brand E machines. The shelf life of products sterilized in packaging made of polyethylene film is - up to 5 years, in parchment or paper - 20 days	Stationary gas sterilizer, microanaerostat MI
	2000	0,81	595	55	+/- 5		240	-/+ 5	For products made of polymeric materials (rubber, plastic), glass, metal
	2000	0,81	595	55	+/- 5		360	-/+ 5	For plastic magazines to stitching machines
Ethylene oxide	1200	0,68	498	At least 18	+5		960	-/+ 5	For products made of polymer materials, glass, metal		Portable apparatus, microanaerostat MI
Mixture OB	2000	0,70	510

Notes

1. Products after pre-sterilization treatment are dried at room temperature or at a temperature of 35 degrees C until visible moisture disappears, after which they are packaged unassembled.

2. To maintain the required sterilization temperature (35.55 degrees), microanaerostats are placed in a thermostat or water bath.

3. When using a microanaerostat or portable device, after the end of the sterilization exposure, they are opened in a fume hood and kept for 5 hours.

Gas is removed from the stationary apparatus by 10-fold evacuation.

4. Products sterilized by the gas method are used after keeping them in a ventilated room (at an air speed of 20 cm/s) for:

1 day - for glass and metal products;

5 - 14 days - for products made of polymeric materials (rubber, plastic); specific ventilation periods must be specified in the technical specifications for specific products;

14 days - for all products that have prolonged contact (over 30 minutes) with mucous membranes, tissues, blood;

21 days - for products made of polymer materials used for children with prolonged contact (over 30 minutes).

Table 8

CHEMICAL STERILIZATION METHOD (GAS) STERILIZATION WITH A MIXTURE OF WATER VAPOR AND FORMALDEHYDE

Sterilizing agent

Sterilization mode

Neutralization

Applicability

Conditions for sterilization

Equipment used

Temperature, degrees C

Relates. humidity, %

Sterilization. shutter speed, min.

Amount of formaldehyde, cubic cm

Holding time, min.

Amount of ammonia, cubic cm

nominal meaning

prev deviation

nominal meaning

limit. deviation

nominal meaning

prev deviation

formalin
16%
solution (according to
formaldehyde)

-/+ 5

36 +/-
2

300

+/- 5

120

+/- 5

For products made of rubber, polymer materials, metal and glass

Sterilization is carried out in packaging made of polyethylene with a thickness of 0.06-0.2 mm or parchment or sulfite wrapping paper (Kraft). The shelf life of products sterilized in packaging made from polyethylene film is 5 years, from parchment or kraft paper - 21 days.

Stationary formalin sterilizer

Note. To neutralize formaldehyde, an aqueous solution of ammonia (23 - 25%) is used.

Table 9

CHEMICAL STERILIZATION METHOD (GAS) FORMALDEHYDE STERILIZATION FROM PARAFORMALDEHYDE

Sterilizing agent	Sterilization mode					Applicability	Conditions for sterilization	Equipment used
	Temperature, degrees C		Relates. humidity, %	Holding time, min.
	nominal meaning	limit. deviation		nominal meaning	limit. deviation
Paraformaldehyde Uniform distribution of paraformaldehyde along the bottom of the chamber, layer thickness 1 cm	22	+/- 2	36 +/- 2	300	+/- 10	Recommended for all-metal stainless steel cutting tools	Sterilization is carried out without packaging, placing the products on a perforated shelf in no more than two layers in mutually perpendicular directions. The shelf life of sterilized products in a sterile container (sterilization box) lined with a sterile sheet is 3 days.	The chamber is made of plexiglass, the ratio of floor area to volume is 1:20, has a perforated shelf with holes with a diameter of 0.6 - 0.7 cm (1 hole per 1 sq. cm). The shelf is installed at a level of 2 cm from the surface of the paraformaldehyde
	14	+2		360	+/- 10

Table 10

DISINFECTION OF MEDICAL DEVICES<*>

Disinfection method

Disinfectant agent

Disinfection mode<**>

Applicability

Conditions for sterilization

Equipment used

Temperature, degrees C

Concentration, %

Holding time, min.

nominal meaning

limit. deviation

nominal meaning

limit. deviation

Boiling

Distilled water

+/- 1

Recommended for products made of glass, metal, heat-resistant polymer materials, rubber

Complete immersion of products in water

Disinfection boiler

Distilled water with sodium bicarbonate (baking soda)

2,0

Steam

Saturated water steam under excess pressure P = 0.05 MPa (0.5 kgf/sq. cm)

110

+/- 2

Recommended for glass, metal, rubber, latex and heat-resistant polymers

Carried out in sterilization boxes

Steam sterilizer. Disinfection chambers

Air

Dry hot air

130

+2 -10

Recommended for glass and metal products

Disinfection should be carried out without packaging (in trays)

Air sterilizer with chamber volume up to 80 cubic meters. dm

Chemical

Triple solution: formalin (formaldehyde) sodium phenol bicarbonate

At least 18

2,0
0,3
1,5

Recommended for products made of glass, corrosion-resistant metal, polymer materials, rubber

Complete immersion of the product in the solution

Closed containers made of glass, plastic or enamel coated (enamel without damage)

Chloramine

1,0
5,0
3,0

30
240
60

Complete immersion of the product in the solution or 2 times wiping with a calico napkin with an interval of 15 minutes between wiping

Hydrogen peroxide

Gibitan

2,5

Dichlor-1

1,0
3,0
3,0

Recommended for products made of glass, corrosion-resistant metal, polymer materials

Wipe twice with a napkin made of calico or gauze with an interval between wipes of 10 - 15 minutes

Sulfochloranthine

0,1
1,0
0,2

Chlorvin

0,5
3,0
1,0

Desams

0,25
0,5

Hydrogen peroxide with 0.5% detergent (Progress, Astra, Aina, Lotus)

3,0
3,0
4,0

Recommended for products made of glass, corrosion-resistant metal, polymer materials, rubber

Neutral calcium hypochlorite or dibasic salt of calcium hynochlorite

0,25
1,0

<*>A detailed description of the disinfection of individual products for specific infectious diseases is given in the relevant Orders and guidelines specified in Appendix 2 of this OST.

<**>The chemical disinfection regime is given in three options:

1 - should be used for purulent diseases, intestinal and airborne infections of bacterial and viral etiology (influenza, adenoviral diseases, etc.), hibitan - only of bacterial etiology;

2 - for tuberculosis;

3 - for viral hepatitis.

Notes

1. When developing medical products, control of resistance to a disinfectant agent should be carried out according to the regimen used for tuberculosis, and if the drug is not recommended for this infection, then according to the regimen used for viral hepatitis.

2. Disinfection of medical instruments can be carried out with medical hydrogen peroxide and technical grades A and B, followed by washing of the instruments.

3. The concentration of the disinfectant: chloramine, dichlor-1, sulfochloranthine, chlorpin, desam, ditritibasic salt of calcium hypochlorite, neutral calcium hypochlorite is given according to the preparation.

4. For products and their parts that are not in direct contact with the patient, wiping should be carried out with a napkin soaked in a disinfectant solution and wrung out to prevent the disinfectant solution from getting into the product.

5. After disinfection by immersion, the products must be washed in running water until the smell of the disinfectant is completely removed.

6. The disinfectant solution should be used once.

7. When disinfecting by boiling and steam, products made of rubber and polymer materials must be packaged in gauze.

2. GOST 1341-74 "Parchment. Technical conditions"

3. GOST 1625-75 "Technical formalin. Technical conditions"

4. GOST 2156-76 "Sodium bicarbonate. Technical conditions"

5. GOST 2228-81 "Sack paper. Technical conditions"

6. GOST 2874-82 "Drinking water. Hygienic requirements and quality control"

7. GOST 4201-72 "Sodium carbonate. Technical conditions"

8. GOST 5850-72 "Phenolphthalein"

9. GOST 6700-72 "Distilled water"

10. GOST 7247-73 "Paper for packaging products on automatic machines"

11. GOST 7568-73 "Ethylene oxide. Technical conditions"

12. GOST 10354-82 "Polyethylene film. Technical conditions"

13. GOST 11680-76 "Cotton fabrics of calico group. Technical conditions"

14. GOST 13302-73 "Calcium hypochlorite two-tertiary basic"

15. GOST 35263-82 "Neutral calcium hypochlorite. Technical conditions"

Industry Standards (OST)

1. OST 6-01-76-7 "Chloramine B technical"

2. OST 6-15-1012-76 "Synthetic detergents. Powders"

Technical conditions (TU)

1. TU 6-01-746-72 "Sulfochloranthin"

2. TU 6-02-06-06-78 "Dezoxon-1"

3. TU 6-15-547-82 "Chlorine-containing bleaches"

4. TU 6-15-1128-78 "Medicine "Chlorpin"

5. TU 6-15-1101-70 "Disinfectant "Dezam"

6. TU 6-09-1224-76 "Sodium oleate"

7. TU 6-08-2785-78 "Sodium benzoate"

8. TU 6-22-1-74 "Methyl bromide"

9. TU 18 RSFSR 718-77 "Biolot"

10. TU 38-10710-77 "Liquid detergent "Progress".

Appendix 2
Information

SCROLL
INSTRUCTIONAL AND METHODOLOGICAL DOCUMENTS ON STERILIZATION AND DISINFECTION

1. ST SEV 3188-81 "Medical products. Methods, means and regimes of sterilization and disinfection. Terms and definitions."

2. GOST 25375-82 "Methods, means and modes of sterilization and disinfection of medical devices. Terms and definitions."

3. OST 64-1-337-78 "Resistance of medical metal instruments to means of pre-sterilization cleaning, sterilization and disinfection. Classification. Selection of method."

4. Temporary instructions for sterilization of packaged disposable plastic magazines for surgical draining devices (approved by the USSR Ministry of Health 09.11.72 N 995-72).

6. Temporary instructions for washing and sterilizing surgical instruments and plastic products with hydrogen peroxide and a mixture of ethylene oxide and methyl bromide (approved by the USSR Ministry of Health on August 25, 1972 N 988-72).

7. Guidelines for the control of steam sterilizers (autoclaves) in medical institutions (types "AV", "AG", AP" and "AOB") (approved by the USSR Ministry of Health on November 28, 1972 N 998-72).

9. Guidelines for pre-sterilization treatment and sterilization of rubber products and components for medical purposes (approved by the USSR Ministry of Health 06.29.76 N 1433).

10. Guidelines for sterilizing dressings, surgical linen, surgical instruments, rubber gloves, glassware and syringes in steam sterilizers (approved by the USSR Ministry of Health 08/12/80 N 28-4/6).

12. Guidelines for pre-sterilization cleaning of medical products (approved by the USSR Ministry of Health 06/08/82 N 28-6/13).

13. Order of the Ministry of Health of the USSR N 720 of July 31, 1978 “On improving medical care for patients with purulent surgical diseases and strengthening measures to combat nosocomial infections.”

14. Order of the Ministry of Health of the USSR N 1230 of December 6, 1979 “On the prevention of diseases in obstetric hospitals.”

15. Order of the Ministry of Health of the USSR N 752 of July 8, 1981 “On strengthening measures to reduce the incidence of viral hepatitis.”

16. Order of the Ministry of Health of the USSR N 916 of August 4, 1983 “On approval of instructions on the sanitary and anti-epidemic regime and labor protection of personnel of infectious diseases hospitals (departments).”

17. Guidelines for the classification of foci of tuberculosis infection, implementation and quality control of disinfection measures for tuberculosis (approved by the USSR Ministry of Health on May 4, 1979 N 10-8/39).

18. Guidelines for the use of chloramine for disinfection purposes (approved on October 21, 1975 N 1359-75).

19. Instructions for the use of hydrogen peroxide with detergents for disinfection purposes (approved by the USSR Ministry of Health 08.29.70 N 858-70).

20. Guidelines for the use of sulfochlorantine for disinfection purposes (approved by the USSR Ministry of Health on June 23, 1977 N 1755-77).

21. Guidelines for the use of chlorpin for disinfection (approved by the USSR Ministry of Health 12/24/80 N 28-13/5).

22. Guidelines for the use of desam for disinfection (approved by the USSR Ministry of Health on December 24, 1980 N 28-14/6).

23. Guidelines for sterilization in a formaldehyde sterilizer.

24. Guidelines for the use of gibitan for disinfection 08/26/81 N 28-6/4.

25. Order of the USSR Ministry of Health No. 60 dated January 17, 1970 “On measures to further strengthen and develop disinfection business.”

27. Instructions for disinfection and disinsection of clothing, bedding, shoes and other objects in steam-air-formalin, steam and combined chambers and disinsection of these objects in air disinfection chambers (08.20.77).

Director of VNIIDiS
P.P.LYARSKY

DEVELOPED by the All-Union Scientific Research Institute of Disinfection and Sterilization (VNIIDiS)

Director of the Institute Lyarsky P.P.
Deputy Director Kruchenok T.B.
Head of the sterilization department Ramkova N.V.
Head of the disinfection department Sokolova N.F.
Performers: Abramova I.M., Guterman R.L., Evtikova L.V., Ioirish A.N., L.S. Troshin K.A., Yuzbashev V.G.

All-Union Scientific Research and Testing Institute of Medical Equipment (VNIIIIMG)

Director of the Institute Leonov B.I.
Performers: Tereshenkov A.I., Rybchinokaya N.A.

AGREED:

Main Directorate of Quarantine Infections of the USSR Ministry of Health
Head of Department Sergiev V.P.

PREPARED FOR APPROVAL

Directorate for the Introduction of New Medicines and Medical Equipment of the USSR Ministry of Health
Head of Department Babayan E.A.

APPROVED

Ministry of Health of the USSR Deputy Minister O.P. Shchepin

PUT INTO EFFECT

FINISHED

For the All-Union Scientific Research Institute of Disinfection and Sterilization (VNIIDiS) and

All-Union Scientific Research and Testing Institute of Medical Equipment (VNIIIMT)

Registered and entered into the state registration register on July 12, 1985 No. 8355618

1.
2.
3.
4.
Annex 1
Appendix 2

INDUSTRY STANDARD

STERILIZATION AND DISINFECTION OF MEDICAL DEVICES
Methods, means and modes
OST 42-21-2-85 Instead of OST 42-2-2-77

By order of the USSR Ministry of Health of June 10, 1985 No. 770, the introduction period was set from 01/01/1986.

Failure to comply with the standard is punishable by law

This standard applies to medical devices that are subjected to sterilization and (or) disinfection during use.

The standard is mandatory for institutions operating medical devices, as well as for organizations and enterprises developing and manufacturing medical devices.

The standard does not apply to medicines and their packaging, to products produced by industry as sterile, to products made from textile materials (in terms of disinfection), patient care items, and medical furniture.

The standard establishes methods, means and modes of pre-sterilization cleaning, sterilization and disinfection.

Basic concepts from the field of pre-sterilization cleaning, sterilization and disinfection according to GOST 25375-82 (ST SEV 3188-81).

The list of regulatory and technical documents for chemical reagents and auxiliary materials is given in Reference Appendix 1 to this standard.

The list of instructions and methodological documents of the USSR Ministry of Health on issues of sterilization and disinfection is given in reference appendix 2 to this standard.

1. General Provisions

1.1. The methods, means and modes of pre-sterilization cleaning, sterilization and disinfection established in this standard are equivalent in effectiveness for each type of treatment.

Note. Preference should be given to thermal sterilization methods (steam and air).

The selected methods, means and modes should not cause changes in the appearance, performance and other indicators of the product; processed products should not have a toxic effect.

In technical specifications, in standards for mass-produced products, the requirement for resistance of products to pre-sterilization cleaning and a specific method of sterilization or disinfection should be standardized taking into account the provisions of this standard based on the results of preliminary tests.

1.5. During the operation of products, pre-sterilization cleaning, sterilization and (or) disinfection must be carried out in accordance with this standard and instructions approved by the USSR Ministry of Health, developed on the basis of this standard, establishing the procedure for pre-sterilization cleaning, sterilization, disinfection of specific types of products, as well as operational documentation.

1.6. The requirements of technical documentation (including operational documentation) regarding pre-sterilization cleaning, sterilization and disinfection must comply with this standard, instructions approved by the USSR Ministry of Health, and in the absence of these instructions for certain types of products must be agreed with the Office for the Introduction of New Medicines and medical equipment of the USSR Ministry of Health.

1.8. Sterility control should be carried out by bacteriological laboratories of sanitary and epidemiological stations and medical and preventive institutions in accordance with instructions approved by the USSR Ministry of Health.

2. Pre-sterilization cleaning

2.1. All products must undergo pre-sterilization cleaning before they are sterilized in order to remove protein, fat and mechanical contaminants, as well as medications.

2.2. Detachable products must undergo pre-sterilization cleaning when disassembled.

2.3. Pre-sterilization cleaning must be carried out manually or mechanized (using special equipment).

The method of performing mechanized cleaning must comply with the operating instructions supplied with the equipment.

Note. Rubbing rubber products is not allowed.

2.5. Pre-sterilization cleaning manually should be carried out in the sequence in accordance with table. 1.

2.6. When using a washing solution containing 0.5% hydrogen peroxide and 0.5% synthetic Lotus detergent, a corrosion inhibitor is used - 0.14% sodium oleate.

2.7. At the end of the work shift, the equipment must be cleaned mechanically by washing with detergents.

2.8. The cleaning solution must include components in accordance with table. 2.

3. Sterilization

3.1. All products that come into contact with the wound surface, come into contact with blood or injectable drugs, and certain types of medical instruments that, during operation, come into contact with the mucous membrane and can cause damage to it, must be sterilized.

3.2. Sterilization should be carried out by one of the methods given in table. 4 - 8.

4. Disinfection

4.1. All products that do not have contact with the wound surface, blood or injectable drugs must be disinfected.

Products used during purulent operations or surgical manipulations in an infectious patient are disinfected before pre-sterilization cleaning and sterilization.

In addition, medical products must be disinfected after operations, injections, etc. persons who have had hepatitis B or hepatitis with an unspecified diagnosis (viral hepatitis), as well as those who are carriers of the HB antigen.

Disinfection should be carried out using one of the methods indicated in the table. 9.

Table 1. Pre-sterilization cleaning

* The solution temperature is not maintained during the washing process

Notes

1. If an instrument contaminated with blood can be washed under running water immediately after use during surgery or manipulation, it should not be immersed in a solution of corrosion inhibitor (sodium benzoate).

2. If necessary (duration of operation), the instrument can be left immersed in a solution of corrosion inhibitor (sodium benzoate) for up to 7 hours.

3. The cleaning solution can be used until it becomes dirty (until a pink color appears, which indicates contamination of the solution with blood, which reduces the cleaning efficiency). A washing solution of hydrogen peroxide with synthetic detergents can be used within 24 hours from the date of manufacture if the color of the solution has not changed. The unchanged solution can be heated up to 6 times; during the heating process, the concentration of hydrogen peroxide does not change significantly.

4. The drying regime for endoscopes and products made of natural latex, as well as the requirements for immersing endoscopes in solutions, must be set out in the operating instructions for these products.

Table 2. Preparation of detergent

x - For pre-sterilization cleaning, it is allowed to use medical hydrogen peroxide, as well as technical grades A and B hydrogen peroxide. The amounts of hydrogen peroxide given in the table are calculated for a solution with a concentration of 27.5%.

xx - Organizations developing and manufacturing medical products, when testing the resistance of products to pre-sterilization cleaning agents, must use solutions of hydrogen peroxide with detergents.

Table 3. Chemical cleaning of stainless steel surgical instruments

x For stainless steel scalpels.
xx For instruments with an oxide film.
xxx For instruments with severe corrosion, it is recommended to additionally clean the damaged areas with a brush or cotton-gauze swab.

Table 4. Steam sterilization method (saturated water steam under excess pressure)

Notes

1. Sterilization boxes are not packaging for storing sterilized products, but if the sterilized material is stored in boxes for the time specified in the table, it can be used for its intended purpose.

2. Products made of corrosion-resistant metal according to OST 64-1-72-80 and OST 64-1-337-78.

Table 5. Air sterilization method (dry hot air)

Table 6. Chemical sterilization method (chemical solutions)

x The hydrogen peroxide solution can be used within 7 days from the date of preparation, provided it is stored in a closed container in a dark place. Further use of the solution can only be carried out if the content of active substances is controlled.

xx The temperature of the solution is not maintained during the sterilization process.

xxx The Dezoxon-1 solution can be used for one day.

xxxx Organizations that develop and manufacture products may use non-sterile water when testing the resistance of products to sterilization agents.

Table 7. Chemical sterilization method (gas) sterilization with a mixture of OB and ethylene oxide

Notes

1. Products after pre-sterilization treatment are dried at room temperature or at a temperature of 35 PS until visible moisture disappears, after which they are packaged unassembled.

2. To maintain the required sterilization temperature (35, 55 P), microanaerostats are placed in a thermostat or water bath.

3. When using a microanaerostat or portable device, after the end of the sterilization exposure, they are opened in a fume hood and kept for 5 hours. Gas is removed from the stationary apparatus by 10-fold evacuation.

4. Products sterilized by the gas method are used after keeping them in a ventilated room (at an air speed of 20 cm/s) for:

1 day - for glass and metal products;

5 - 13 days - for products made of polymeric materials (rubber, plastics) with short-term contact (up to 30 minutes); specific ventilation periods must be specified in the technical specifications for specific products;

14 days - for all products that have prolonged contact (over 30 minutes) with mucous membranes, tissues, blood;

21 days - for products made of polymer materials with prolonged contact (over 30 minutes) used for children.

Table 8. Chemical sterilization method (gas) sterilization with a mixture of water vapor and Formaldehyde

Note. To neutralize formaldehyde, an ammonia aqueous solution (23 - 25%) is used.

Table 9. Disinfection of medical devices*

x A detailed description of the disinfection of individual products for specific infectious diseases is given in the relevant orders and guidelines specified in Appendix 2 of this OST.

xx The chemical disinfection mode is given in three options:

1 - should be used for purulent diseases, intestinal and airborne infections of bacterial and viral etiology (influenza, adenoviral diseases, etc.), hibitan - only of bacterial etiology;

2 - for tuberculosis;

3 - for viral hepatitis.

Notes

2. Disinfection of medical instruments can be carried out with medical hydrogen peroxide and technical grades A and B, followed by washing of the instruments.

3. The concentration of the disinfectant: chloramine, dichlor - 1, sulfochloranthine, chlorocin, desam, neutral calcium hypochlorite is given according to the preparation.

5. After disinfection by immersion, the products must be washed in running water until the smell of the disinfectant is completely removed.

6. The disinfectant solution should be used once.

7. When disinfecting by boiling and steam, products made of polymer materials must be packaged in gauze.

Annex 1
(informative)

Regulatory and technical documentation for chemical reagents and auxiliary materials

State standards (GOST), industry standards (OST)

1. GOST 177-77 “Hydrogen peroxide. Technical specifications"
2. GOST 1341-74 “Parchment. Technical specifications"
3. GOST 1625-75 “Technical formalin. Technical specifications"
4. GOST 2156-76 “Sodium bicarbonate. Technical specifications"
5. GOST 2228-81 “Sack paper. Technical specifications"
6. GOST 2874-82 “Drinking water. Hygienic requirements and quality control"
7. GOST 4201-79 “Sodium bicarbonate acid. Technical specifications"
8. GOST 5850-72 “Phenolphthalein”
9. GOST 6709-72 “Distilled water”
10. GOST 7247-73 “Paper for packaging products on automatic machines”
11. GOST 7568-73 “Ethylene oxide. Technical specifications"
12. GOST 10354-82 “Polyethylene film. Technical specifications"
13. GOST 11680-76 “Cotton fabrics of calico group. Technical conditions".
14. GOST 25263-82 “Neutral calcium hypochlorite. Technical specifications"
15. GOST 25644-83 “Synthetic powder detergents. Technical specifications"
16. OST 6-01-75-79 “Chloramine B technical”

Technical conditions (TU)

1. TU 6-01-746-72 “Sulfochloranthin”
2. TU 6-02-09-06-78 “Dezoxon - 1”
3. TU 6-15-547-82 “Chlorine-containing bleaches”
4. TU 6-15-1128-78 “Medicine “Chlorcin”
5. TU 6-15-1191-79 “Disinfectant “Dezam”
6. TU 6-09-1224-76 “Sodium oleate”
7. TU 6-09-2785-78 “Sodium benzoate”
8. TU 6-22-1-74 “Methyl bromide”
9. TU 18 RSFSR 718-77 “Biolot”
10. TU 38-10719-77 “Liquid detergent “Progress”

Appendix 2
(informative)

List of instructional and methodological documents on sterilization and disinfection

1. ST SEV 3188-81 “Medical products. Methods, means and regimes of sterilization and disinfection. Terms and Definitions".

2. GOST 25375-82 “Methods, means and modes of sterilization and disinfection of medical products. Terms and Definitions".

3. OST 64-1-337-78 “Resistance of medical metal instruments to means of pre-sterilization cleaning, sterilization and disinfection. Classification. Choice of method".

4. Temporary instructions for sterilization of packaged disposable plastic magazines for surgical staplers (approved by the USSR Ministry of Health on November 9, 1972, No. 995-72).

7. Guidelines for the control of steam sterilizers (autoclaves) in medical institutions (types “AV”, “AG”, “ASH” and “AOV”) (approved by the USSR Ministry of Health on November 28, 1972, No. 998-72).

9. Guidelines for pre-sterilization treatment and sterilization of rubber products and components for medical purposes (approved by the USSR Ministry of Health on June 29, 1976, No. 1433).

10. Guidelines for sterilizing dressings, surgical linen, surgical instruments, rubber gloves, glassware and syringes in steam sterilizers (approved by the USSR Ministry of Health on August 12, 1980, No. 28-4/6).

12. Guidelines for pre-sterilization cleaning of medical products (approved by the USSR Ministry of Health on June 8, 1982, No. 28-6/13).

13. Order of the USSR Ministry of Health of July 31, 1978 No. 720 “On improving medical care for patients with purulent surgical diseases and strengthening measures to combat nosocomial infections.”

14. Order of the USSR Ministry of Health of December 6, 1979 No. 1230 “On the prevention of diseases in obstetric hospitals.”

15. Order of the USSR Ministry of Health of July 8, 1981 No. 752 “On strengthening measures to reduce the incidence of viral hepatitis.”

16. Order of the USSR Ministry of Health of August 4, 1983 No. 916 “On approval of instructions on the sanitary and anti-epidemic regime and labor protection of personnel of infectious diseases hospitals (departments).”

18. Guidelines for the use of chloramine for disinfection purposes (approved on October 21, 1975 No. 1359-75).

19. Instructions for the use of hydrogen peroxide with detergents for disinfection purposes (approved by the USSR Ministry of Health on August 29, 1970, No. 858-70).

20. Guidelines for the use of sulfochlorantine for disinfection purposes (approved by the USSR Ministry of Health on June 23, 1977, No. 1755-77).

21. Guidelines for the use of chlorcin for disinfection (approved by the USSR Ministry of Health dated December 24, 1980 No. 28.13/6).

22. Guidelines for the use of desam for disinfection (approved by the USSR Ministry of Health on December 24, 1980, No. 28-14/6).

23. Guidelines for the sterilization of some hemosorbents (approved by the USSR Ministry of Health on December 28, 1983, No. 28-6/5).

24. Guidelines for the use of gibitan for disinfection (approved by the USSR Ministry of Health on August 26, 1981, No. 28-6/4).

25. Order of the USSR Ministry of Health dated January 17, 1979 No. 60 “On measures to further strengthen and develop disinfection business.”

27. Instructions for disinfection and disinsection of clothing, bedding, shoes and other objects in steam-air-formalin, steam and combined disinfection chambers and disinsection of these objects in air disinsection chambers (approved by the USSR Ministry of Health on August 29, 1977).

INDUSTRY STANDARD

STERILIZATION AND DISINFECTION
MEDICAL DEVICES

METHODS, MEANS AND MODES

OST 42-21-2-85

DEVELOPED by the All-Union Scientific Research Institute of Disinfection and Sterilization (VNIIDiS)

Director of the Institute Lyarsky P.P.

Deputy Director Kruchenok T.B.

Head of the sterilization department Ramkova N.V.

Head of the disinfection department Sokolova N.F.

Performers: Abramova I.M., Guterman R.L., Evtikova L.V.,

Ioyirish A.N., L.S. Troshin K.A., Yuzbashev V.G.

All-Union Scientific Research and Testing Institute of Medical Equipment (VNIIIIMG)

Director of the Institute Leonov B.I.

Performers: Tereshenkov A.I., Rybchinokaya N.A.

AGREED:

Main Directorate of Quarantine Infections of the USSR Ministry of Health

Head of Department Sergiev V.P.

PREPARED FOR APPROVAL

Directorate for the Introduction of New Medicines and Medical Equipment of the USSR Ministry of Health

Head of Department Babayan E.A.

APPROVED

Ministry of Health of the USSR

Deputy Minister O.P. Shchepin

PUT INTO EFFECT

FINISHED

For the All-Union Scientific Research Institute of Disinfection and Sterilization (VNIIDiS) and

All-Union Scientific Research and Testing Institute of Medical Equipment (VNIIIMT)

Registered and entered into the state registration register on July 12, 1985 No. 8355618

INDUSTRY STANDARD

By order of the USSR Ministry of Health of June 10, 1985 No. 770, the introduction period was set from 01/01/1986.

Failure to comply with the standard is punishable by law

This standard applies to medical devices that are subjected to sterilization and (or) disinfection during use.

The standard is mandatory for institutions operating medical devices, as well as for organizations and enterprises developing and manufacturing medical devices.

The standard establishes methods, means and modes of pre-sterilization cleaning, sterilization and disinfection.

Basic concepts from the field of pre-sterilization cleaning, sterilization and disinfection according to GOST 25375-82 (ST SEV 3188-81).

The list of regulatory and technical documents for chemical reagents and auxiliary materials is given in the reference appendix to this standard.

The list of instructions and methodological documents of the USSR Ministry of Health on sterilization and disinfection is given in the reference appendix to this standard.

. General provisions

Pre-sterilization cleaning

Cleaning mode

Equipment used

Holding time, min

nominal value

maximum deviation

nominal value

maximum deviation

Immersion of instruments contaminated with blood in a solution of corrosion inhibitors (1% sodium benzoate solution) immediately after using them during surgery or manipulation

Basin, tank

Rinsing with running water

Bath, sink

Soaking in a washing solution (p.) when the product is completely immersed

Cistern, bathtub, sink

when using detergents “Progress”, “Astra”, “Lotus”, “Aina”

Washing each product in a washing solution (p.) using a brush or cotton-gauze swab

Rinsing under running water

when using Biolot detergent

Bathtub, sink with jet water supply

when using Progress detergent

when using detergents “Astra”, “Lotos”, “Aina”

Rinsing with distilled water

Cistern, bath

Hot air drying

until moisture completely disappears

drying cabinet

* The solution temperature is not maintained during the washing process

Notes 1. If an instrument contaminated with blood can be washed under running water immediately after use during surgery or manipulation, it should not be immersed in a solution of corrosion inhibitor (sodium benzoate).

2. If necessary (duration of operation), the instrument can be left immersed in a solution of corrosion inhibitor (sodium benzoate) for up to 7 hours.

3. The cleaning solution can be used until it becomes dirty (until a pink color appears, which indicates contamination of the solution with blood, which reduces the cleaning efficiency). A washing solution of hydrogen peroxide with synthetic detergents can be used within 24 hours from the date of manufacture if the color of the solution has not changed. The unchanged solution can be heated up to 6 times; during the heating process, the concentration of hydrogen peroxide does not change significantly.

Preparing detergent

Number of components for preparing 1 dm3 cleaning solution

Applicability

Detergent "Biolot", g

Used for mechanized cleaning (jet method, roughening, ultrasound)

Drinking water, cm 3

Detergent "Biolot", g

Used for mechanized cleaning using the rotational method

Drinking water, cm 3

Detergent "Biolot", g

Used for manual cleaning

Drinking water, cm 3

Hydrogen peroxide solution x, cm 3

Used for mechanized (jet method, roughening, ultrasound) and manual cleaning

Detergent

(“Progress”, “Aina”, “Astra”,

"Lotus") xx, g

Drinking water, cm 3

Detergent "Lotus", g

Used for mechanized cleaning using ultrasound

Drinking water, cm

Chemical cleaning of stainless steel surgical instruments

Cleaning mode

Equipment used

Initial solution temperature, ° C

Holding time, min

nominal value

maximum deviation

nominal value

maximum deviation

Pre-rinse with running water

±0.1

Bath, sink

Soaking in solution:

± 1.0

Enameled, glass, polyethylene container with lid

acetic acid - 5 g

± 1.0

(recalculation to 100%)

sodium chloride - 1 g

distilled water -

Rinsing with running water

±0.1

Bath, sink

Sheet, diaper, towel

x For stainless steel scalpels.

xx For instruments with an oxide film.

xxx For instruments with severe corrosion, it is recommended to additionally clean the damaged areas with a brush or cotton-gauze swab.

Steam sterilization method (saturated water steam under excess pressure)

Applicability

Sterility retention period

Equipment used

Steam pressure in the sterilization chamber, MPa (kgf/cm2)

Sterilization holding time, min

with manual and semi-automatic control, not less

With automatic control

nominal value

limit value

nominal value

limit value

nominal value

maximum deviation

±0.02

Sterilization is carried out in sterilization boxes without filters or in sterilization boxes with a filter, or in double soft packaging made of calico, parchment, unimpregnated bag paper, moisture-resistant bag paper, paper for packaging products on E-type machines (density polyethylene, PVC plastics)

The shelf life of sterilization of products sterilized in sterile boxes without filters, in double soft packaging made of calico or parchment, unimpregnated paper, bag paper for packaging products on brand E machines is t 3 days, in sterilization boxes with a filter 20 days

Steam sterilizer

(±0.2)

Air sterilization method (dry hot air)

Applicability

Conditions for sterilization

Sterility retention period

Equipment used

Operating temperature in the sterilization chamber, ° C

Holding time, min

nominal value

maximum deviation

nominal value

maximum deviation

Dry products are subjected to sterilization. Sterilization is carried out in packaging made of unimpregnated sack paper, moisture-resistant sack paper, paper for packaging products on E-type machines or without packaging (in open containers)

Products sterilized in unimpregnated sack paper and moisture-resistant sack paper, paper for product packaging on E-type machines can be stored for 3 days. Products sterilized without packaging should be used immediately after sterilization

Air sterilizer

Chemical sterilization method (solutions of chemicals)

Sterilization mode

Applicability

Conditions for sterilization

Equipment used

Temperature, ° C

Holding time, min

nominal value

maximum deviation

nominal value

maximum deviation

Hydrogen peroxide 6% solution x

At least 18

Sterilization should be carried out by completely immersing the product in the solution for the duration of the sterilization exposure, after which the product should be washed with sterile water xxx

The shelf life of a sterilized product in a sterile container (sterilization box) lined with a sterile sheet is 3 days.

Closed containers made of glass, plastic or coated with enamel (enamel without damage)

xx The temperature of the solution is not maintained during the sterilization process.

xxx The Dezoxon-1 solution can be used for one day.

xxxx Organizations that develop and manufacture products may use non-sterile water when testing the resistance of products to sterilization agents.

Chemical sterilization method (gas) sterilization with a mixture of OB and ethylene oxide

Sterilization mode

Applicability

Conditions for sterilization

Equipment used

Gas dose

Operating temperature in the sterilization chamber, ° C

Relative humidity, %

Holding time, min

mm. rt. Art.

nominal value

maximum deviation

nominal value

maximum deviation

Mixture of OB (ethylene oxide with methyl bromide in a ratio of 1:0.5 by substance, respectively)

not less than 80

For optics, pacemakers

Sterilization is carried out in a package of two layers of polyethylene film 0.06 m thick, parchment, unimpregnated sack paper, moisture-resistant sack paper, paper for packaging products on E-type machines. The shelf life of products sterilized in plastic film packaging is up to 5 years, in parchment or paper - 20 days.

Stationary gas sterilizer, microanaerostat MI

For products made of polymeric materials (rubber, plastic), glass, metal

For plastic magazines to stitching machines

Ethylene oxide

at least 18

For products made of polymer materials, glass, metal

Portable apparatus, microanaerostat MI

Chemical sterilization method (gas) sterilization with a mixture of water vapor and formaldehyde

Sterilizing agent

Sterilization mode

Neutralization

Applicability

Conditions for sterilization

Equipment used

temperature, ° WITH

relative humidity, %

sterilization exposure, min

amount of formaldehyde, cm 3

holding time, min

amount of ammonia, cm 3

nominal value

maximum deviation

nominal value

maximum deviation

nominal value

maximum deviation

Disinfection of medical products*

	Disinfectant agent	Disinfection mode xx					Applicability	Conditions for disinfection	Equipment used
		Temperature, ° WITH		Concentration, %	Holding time, min
		nominal value	maximum deviation		nominal value	maximum deviation
Boiling	Distilled water							Complete immersion of products in water	Disinfection boiler
	Distilled water with sodium bicarbonate (baking soda)
	Saturated water steam under excess pressure P = 0.05 MPa (0.5 kgf/cm 2)							Carried out in sterilization boxes	Steam sterilizer. Disinfection chambers
Air	Dry hot air							Disinfection should be carried out without packaging (in trays)	Air sterilizer
Chemical	Triple solution of formaldehyde (formaldehyde): sodium phenol bicarbonate	at least 18						Complete immersion of the product in the solution	Closed containers made of glass, plastic


Chemical	Chloramine	at least 18					polymeric materials, rubbers	complete immersion of the product in the solution or wiping twice with a calico napkin with an interval of 15 minutes between wipes	masses or coated with enamel (enamel without damage)


	Hydrogen peroxide	at least 18


	Formalin (based on formaldehyde)


	Dezoxon - 1





								Wipe twice with a calico napkin or gauze with an interval between wipes of 10 - 15 minutes


	Sulfochloranthine



Chemical		at least 18





	Hydrogen peroxide with 0.5% detergent (Progress, Astra, Aina, Lotus)

Document as of January 2016

In accordance with the agreement “Standardization and metrological support of topographic, geodetic and cartographic production” (code 10.197), industry standards “Industry system of labor safety standards. Basic provisions” and “Cartographic devices. General technical conditions” were developed by TsNIIGAiK and adopted by Roscartography. In order to put them into effect and use them in topographic, geodetic and cartographic production, I order:

1. Industry standards “Industry system of occupational safety standards. Basic provisions” and “Cartographic devices. General technical conditions” shall be approved and assigned symbols according to OST 68-12.1-2002 and OST 68-16-2002 (see Appendix).

2. Set the date for the implementation of OST 68-12.1-2002 "Industry system of labor safety standards. Basic provisions" and OST 68-16-2002 "Cartographic devices. General technical conditions" from January 1, 2003.

3. TsNIIGAiK and the Kartgeocentre, before January 1, 2003, publish OST 68-12.1-2002 and OST 68-16-2002 in the amount of 100 copies. each and distribute the circulation according to the order attached to this Order (not provided). The Cartographic Center will post information about the implementation of these industry standards on the Internet on the Roscartography website.

4. Heads of enterprises and organizations of Roscartography ensure the timely implementation of OST 68-12.1-2002 and OST 68-16-2002, as well as compliance with their requirements in the process of production activities.

5. Control over the implementation of this Order is entrusted to the deputy head of Roscartography A.N. Prusakova.

Head of the Federal Service of Geodesy and Cartography of Russia A.A.DRAZHNYUK

INDUSTRY STANDARD

INDUSTRY SYSTEM OF OCCUPATIONAL SAFETY STANDARDS. BASIC POINTS

OST 68-12.0.01-02

1 area of use

This standard establishes the purpose, structure and content of the industry system of occupational safety standards (hereinafter referred to as OSHS), as well as the construction, content and procedure for harmonizing the standards of this system.

The provisions of this standard apply to standards aimed at ensuring safety for all types of work performed in the Roscartography system.

The standard was developed on the basis and development of GOST 12.0.001.

Federal Law "On the Fundamentals of Labor Safety in the Russian Federation" N 181-FZ dated July 17, 1999 GOST 1.4-93 GSS RF. Industry standards, enterprise standards, standards of scientific, technical, engineering societies and other public organizations. General provisions of GOST R 1.5-92 GSS RF. General requirements for the construction, presentation, design and content of GOST 12.0.001-82 SSBT standards. Basic provisions of GOST 12.0.002-80 SSBT. Terms and definitions GOST 12.0.003-74 SSBT. Dangerous and harmful production factors. Classification GOST 12.0.004-90 SSBT. Organization of occupational safety training. General provisions of GOST 12.0.005-84 SSBT. Metrological support in the field of occupational safety. Basic provisions of GOST 12.2.003-91 SSBT. Production equipment. General occupational safety requirements GOST 12.3.002-75 SSBT. Production processes. General safety requirements GOST 30494-96 Residential and public buildings. Indoor microclimate parameters Resolution of the Ministry of Labor of the Russian Federation N 65 "On approval of the standard regulations on the procedure for training and testing knowledge on labor protection of managers and specialists of enterprises, institutions, organizations" dated 10.12.1994 R 2.2.013-94 "Hygienic criteria for assessing conditions of the State Committee for Sanitary and Epidemiological Supervision of Labor according to indicators of the harmfulness and danger of Russia's factors of the working environment, the severity and intensity of the labor process dated July 12, 1994" Resolution of the Ministry of Labor N 12 "Regulations on the procedure for certification of workplaces according to working conditions" dated March 14, 1997 Order of the Ministry of Health and Medical Industry of Russia and the State Committee for Sanitary and Epidemiological Supervision of Russia N 280 /88 “On approval of temporary Lists of harmful, hazardous substances and production factors, as well as work during which preliminary and periodic medical examinations of workers are carried out” dated 10/05/1995 PTB-88 Safety regulations for topographic and geodetic work R-85200- 010-99 Methodological recommendations. On the procedure for certification of workplaces for working conditions in organizations of Roscartography SanPiN 2.2.2.542-96 Hygienic requirements for video display terminals, personal electronic computers and organization of work

3. Definitions, notations and abbreviations

3.1. Definitions

The terms used are in accordance with GOST 12.0.002.

3.2. Notations and abbreviations

State system of labor safety standards - SSBT Industry system of labor safety standards - OSSBT Geodetic and cartographic instructions, norms, rules - GKINP Regulatory documents - ND Safety rules - PTB

4. General provisions

4.1. The requirements of OSHS standards must comply with the requirements of the Federal Law "On the Fundamentals of Occupational Safety and Health in the Russian Federation", State OSHS standards series 12; are interconnected with the requirements, recommendations, norms and rules set forth in Resolution of the Ministry of Labor of the Russian Federation N 65 of October 12, 1994, R 2.2.013-94, Order of the Ministry of Health and Medical Industry of Russia and the State Committee for Sanitary and Epidemiological Supervision of Russia N 280/88 of October 5, 1995, PTB-88, SanPiN 2.2.2.542; provisions of regulatory documents of the GKINP series, current industry standards and regulatory documents regulating labor safety.

4.2. The requirements established by OSHS standards in accordance with their scope must be taken into account in the technical specifications, regulatory, technical, design, technological, operational and project documentation for specific products and types of work in geodetic and cartographic activities.

4.3. Appendix "A" (informational) provides a list of standards of the State System of Occupational Safety Standards, containing general provisions and general requirements of safety standards; Appendix "B" (informational) provides a list of current industry standards and regulatory documents regulating occupational safety issues.

5. Structure of the industry system of occupational safety standards

5.1. The industry system of occupational safety standards includes the groups shown in the table:

┌──────┬───────────────────────────────── ───────── ───────────────┐ │0 │Organizational and methodological standards │ ├──────┼──────── ────────── ───────────────────────────────────────┤ │1 │Standards of requirements and norms for types of hazardous and harmful │ │ │production factors │ ├──────┼────────────────────────── ──────── ───────────────────────┤ │2 │Safety requirements standards for production │ │ │equipment, production processes and applications │ │ │means of protection for workers │ ├─ ─────┼─────────────────────────────────── ───────── ─────────────┤ │3 │Standards of requirements for production, office, │ │ │household premises and structures, sanitary and living │ │ │conditions when carrying out geodetic and cartographic │ │ │works │ └──────┴───────────────────────────────── ───────── ───────────────┘

5.2. Group "0" standards establish:

Organizational and methodological foundations of standardization in the field of occupational safety (goals, objectives and structure of the system, implementation and monitoring of compliance with safety standards, etc.);

Requirements (rules) for the organization of work aimed at ensuring occupational safety (training workers in occupational safety, personnel certification, methods for assessing the state of occupational safety, etc.).

5.3. Standards of group "1" OSSS establish:

Additional requirements to the requirements of group "1" of the safety standards on the specific features of hazardous and harmful production factors and environmental impacts during field and other types of work in the industry;

Maximum permissible values of parameters and characteristics; hazardous and harmful production factors and environmental impacts;

Methods for their control;

Methods of protecting workers from hazardous and harmful production factors and environmental influences.

5.4. Standards of group "2" OSSS establish:

Safety requirements for types and types of production equipment, safety requirements for workplaces;

Safety requirements for types of production processes under specific conditions of their implementation (for example, with the use of vehicles; when calibrating devices in a hospital or in the field);

Requirements for the use of protective equipment for workers when performing specific types of production processes;

Methods for monitoring compliance with safety requirements.

5.5. Group "3" standards establish:

Requirements for household premises and structures, depending on their purpose during field work, in terms of ensuring the safety of people using them and working on them; requirements for sanitary facilities; requirements for sanitary and living conditions when carrying out specific types of field work in various natural conditions in terms of ensuring the preservation of the health of workers;

Requirements for household premises and structures during their installation (for example, tents) or construction, operation, repair and reconstruction;

Methods for monitoring compliance with safety requirements for domestic premises, structures and sanitary conditions.

6. Designations of OSHS standards

The designation of the industry standard OSSHS must consist of: designation of the ND category (for example, OST); index 68, indicating that this standard belongs to industry standards; registration number, the first two digits of which (12 with a dot) determine whether the standard belongs to the OSSBT complex; the subsequent digit with a dot indicates the group of the standard and the two subsequent digits indicate the serial number of the standard in the group. The year of approval or revision of the standard is indicated through a dash.

The notation structure should look like this:

OST68-12.Х.ХХ-ХХ.

registration number ────────\/───── ── / \ OST-68 12. X XX XX ─┬─ ─┬─ ─┬─ ─┬─ │ │ │ │last two digits - year approval or revision │ │ │ │ │ │ serial number of the standard in the group │ │ └── ────────────────────────────────── │ │ group code (clause 5.1) │ └───── OSS system designation BT └─────── ───────────────────────────────────────── ───

Designation example: OST 68-12.0.01-02

7. Construction, content and design of OSSB standards

7.1. The structure, content and presentation of OSHS standards are in accordance with GOST R 1.5 and this standard.

Registration of standards is in accordance with GOST R 1.5.

7.2. The name of the OSHS standard should consist of a group heading - “Industry system of occupational safety standards”, a heading establishing the object of standardization, and a subheading specifying the object of standardization or the nature of the requirements (for example, “General safety requirements”).

7.3. Organizational and methodological EHS safety standards that establish requirements for conducting field work must contain:

Requirements for organizing safe field work in various natural conditions, taking into account the requirements for high-risk work, the possibility of emergency situations, and protection from crime;

Personnel requirements;

The procedure for registering readiness for field work;

Safety requirements for following routes;

The procedure for training and certification of personnel on occupational safety issues.

7.4. EHS standards that establish requirements and standards for types of hazardous and harmful production factors must contain:

Standardized parameters and characteristics of hazardous and harmful production factors that determine their impact on the human body;

Maximum permissible values of parameters and characteristics of weather and climatic factors in the working area, ensuring labor safety during field work (topographic and geodetic work, aerial photography, etc.) in a specific area (plain, taiga, swampy or mountainous terrain, etc.), taking into account hazardous biological factors;

Methods for preventing exposure of workers to hazardous and harmful production factors;

Methods for monitoring parameters and characteristics of hazardous and harmful production factors.

7.5. Features of the construction and content of OSSS standards that establish safety requirements for production equipment are in accordance with GOST 12.2.003-74.

7.6. Features of the construction and content of OSSS standards that establish safety requirements for production processes are in accordance with GOST 12.3.002-75.

7.7. Standards and sections of standards establishing requirements for the use of protective equipment for workers must contain:

List of protective equipment for specific types of work in specific conditions, rules for their use;

Requirements for the operation, care and storage of protective equipment when carrying out all types of work in various conditions (field, office, etc.);

Methods for monitoring quality indicators and assessing the condition of protective equipment during operation.

8. Coordination of the final versions of draft OSHS standards

The final edition of the draft industry standards of the OSSBT series is subject, in accordance with GOST R 1.4, to mandatory approval with the Territorial Body of the Trade Union of Geology, Geodesy and Cartography Workers, as well as with the Head Organization for Standardization of the Roscartography System.

Appendix A (informational)

STATE STANDARDS REGULATING GENERAL OCCUPATIONAL SAFETY REQUIREMENTS

GOST 12.0.001-82 SSBT. Basic provisions of GOST 12.0.002-80 SSBT. Terms and definitions GOST 12.0.004-90 SSBT. Organization of occupational safety training. General provisions of GOST 12.0.005-84 SSBT. Metrological support in the field of occupational safety. Basic provisions of GOST 12.1.004-90 SSBT. Fire safety. General requirements GOST 12.1.007-76 SSBT. Harmful substances. Classification and general safety requirements GOST 12.1.008-76 SSBT. Biological safety. General requirements GOST 12.1.010-76 SSBT. Explosion safety. General requirements GOST 12.1.012-90 SSBT. Vibration safety. General requirements GOST 12.1.019-79 SSBT. Electrical safety. General requirements and nomenclature of types of protection GOST 12.1.040-83 SSBT. Laser safety. General provisions of GOST 12.1.045-84 SSBT. Electrostatic fields. Permissible levels at workplaces and requirements for monitoring GOST 12.2.003-91 SSBT. Production equipment. General occupational safety requirements GOST 12.2.007.0-75 SSBT. Electrical products. General safety requirements GOST 12.2.032-78 SSBT. Workplace when performing work while sitting. General ergonomic requirements GOST 12.2.033-78 SSBT. Workplace when performing work while standing. General ergonomic requirements GOST 12.2.061-81 SSBT. Production equipment. General safety requirements for workplaces GOST 12.3.002-75 SSBT. Production processes. General safety requirements GOST 30494-96 Residential and public buildings. Indoor microclimate parameters

Appendix B (informational)

INDUSTRY STANDARDS AND ND REGULATING ISSUES OF LABOR SAFETY

OST 68 12.0.05-87 System of occupational safety standards. The procedure for training in labor safety and admission to high-risk work in organizations of topographic and geodetic production OST 68 12.0.06-87 System of labor safety standards. Analysis of the causes of industrial injuries in topographic and geodetic production organizations RD BGEI 36-01 Occupational safety requirements for the operation of topographic and geodetic equipment and methods of their control TOI R-85110-008-98 Safety manual for the operation of satellite receiver-indicators when performing topographic and geodetic work R-85200-010-99 Methodological recommendations. On the procedure for certification of workplaces for working conditions in organizations of Roscartography PTB-88 Safety rules for topographic and geodetic work MU 2-73 On the procedure for developing and harmonizing safety requirements in standards and technical conditions SanPiN 2.2.2.542-96 Hygienic requirements for video displays terminals, personal electronic computers and work organization

Approved by the Head of the Federal Service of Geodesy and Cartography of Russia A.A. DRAZHNYUK September 6, 2002

INDUSTRY STANDARD

CARTOGRAPHIC DEVICES. GENERAL TECHNICAL CONDITIONS

OST 68-16-02

1. Developed and submitted for approval by the Federal State Unitary Enterprise Central Order of the Badge of Honor Research Institute of Geodesy, Aerial Photography and Cartography named after. F.N. Krasovsky.

4. Introduced for the first time.

1 area of use

This standard applies to cartographic devices intended for the creation and use of cartographic works. The standard does not apply to projection devices and printing equipment used in map publishing processes.

The devices are manufactured in UHL climatic design, placement category 4.2 according to GOST 15150.

GOST 2.601-95. ESKD. Operational documents.

GOST 9.014-78. ESZKS. Temporary anti-corrosion protection of products. General requirements.

GOST 9.301-86. ESZKS. Metallic and non-metallic inorganic coatings. General requirements.

GOST 9.303-84. ESZKS. Metallic and non-metallic inorganic coatings. General requirements for selection.

GOST 427-75. Metal measuring rulers. Technical conditions.

GOST 3882-74. Hard sintered alloys. Stamps.

GOST 6507-90. Micrometers. Technical conditions.

GOST 8074-82. Instrumental microscopes. Types, main parameters and sizes. Technical requirements.

GOST 12069-90. Length measures are lined. General technical conditions.

GOST 14192-96. Cargo marking.

GOST 15150-69. Machines, instruments and other technical products. Versions for different climatic regions. Categories, conditions of operation, storage and transportation in terms of the impact of environmental climatic factors.

GOST 18179-72. OKB-122-7 grease. Technical conditions.

GOST 21667-76. Cartography. Terms and Definitions.

GOST 22651-77. Cartographic devices. Terms and Definitions.

GOST 25706-83. Measuring magnifiers. Main parameters. General technical conditions.

OST 68-11-96. Drawing instruments and tools for cartographic work. General technical requirements.

3. Classification, definitions and designations

3.1. This standard uses terms according to GOST 21667 and GOST 22651.

3.2. Depending on their purpose, devices are divided into groups and types indicated in Table 1.

Table 1

┌─────────────────┬────────────────────── ─┬─────── ───────────────┐ │ Group │ View │ Purpose │ ├──────────────── ─┼──────── Grav cutting machines │Engraving │Manufacturing │ │ │mapping device │publishing │ │ │Universal │originals │ │ │engraving device │cartographic │ │ │Engraving │works by method │ │ │pantograph │engraving │ │ │Differentiated │ │ │ │engraving │ │ │ │cartographic device│ │ │ │Engraving device │ │ │ │lines │ │ │ │Device for engraving│ │ │ │building signs │ │ │ │Engraving │ │ │ │calipers │ │ │ │Electric calipers │ │ │ │Hatching │ │ │ │engraving device │ │ ├─── ──────────────┼───────────────────────┼── ───────── ───────────┤ │Cartometric │Planimeter │Measurement of lengths │ │ │Curvimeter │segments of curves and │ │ │ │winding lines and │ │ │ │areas on maps, │ │ │ │plans, diagrams │ ├─────────────────┼────────────────────── ─┼─────── ───────────────┤ │Drawing │According to OST 68-11-96 │ │ ├───────────── ────┼─── ────────────────────┼──────────────────── ──┤ │Coordinate │Coordinateograph │Construction similar │ │ │Cartometer │figures, removing and │ │ │ │applying flat │ │ │ │coordinates │ ├───────────────── ┼───────── Systems and │Input complex │Input-output │ │ devices for input │graphic information │graphic │ │and output │Complex output │information │ │graphic │graphic information │ │ │information │ │ │ └─────────── ──────┴── ─────────────────────┴─────────────────── ───┘

4. Technical requirements

4.1. General requirements for devices

4.1.1. Devices must comply with the requirements of this standard and technical specifications for devices of specific types (types) and design documentation.

4.1.2. Metal parts of devices must have a protective and decorative coating. General requirements for the selection of coatings according to GOST 9.301 and GOST 9.303.

4.1.3. Scales, their digitization and other markings printed on instruments must be clear, have no gaps and be made in a way that allows them to be read by the naked eye at a distance of 250 mm at an illumination of 90 lux.

4.1.4. The device kit (as agreed with the Customer) must include: operational documentation (ED) in accordance with GOST 2.601, replacement parts, spare parts and accessories in accordance with ED; upon customer request - repair documentation (RD) in accordance with GOST 2.601.

4.1.5. Materials, semi-finished products and purchased components must have a document or mark confirming their compliance with current standards.

4.1.6. Devices in transport containers must withstand the impact of mechanical and dynamic loads with an acceleration of 30 m/sq. s at a blow frequency of 80 to 120 per minute for 0.5 hours.

4.1.7. The technical specifications for specific types and types of cartographic instruments must indicate the main indicators of purpose, safety and maintainability indicators, overall dimensions and weight, and for measuring instruments - metrological characteristics.

4.2. Requirements for engraving devices

4.2.1. The devices must ensure engraving on an industrial varnish layer with a thickness of 8 - 9 microns on transparent plastic with full removal of the engraving layer without damaging the plastic. Reliability requirements are established in the technical specifications for specific types of devices.

4.2.2. After final assembly and adjustment, the screws and nuts are tightened or locked to ensure they do not become misaligned during operation.

4.2.3. The fastening of the cutters in the tool holders must be rigid; the cutters must not change the set position during operation.

4.2.4. The movement of moving parts and connections should be easy, smooth, without jamming or play.

4.2.5. The cutters must be made of carbon steel with a hard alloy soldered onto the cutting part with a hardness of at least 50 HRC according to GOST 3882.

4.2.6. The thickness of the stroke engraved by the cutter or needle must be marked on cutters and needles.

4.2.7. The sizes of double, triple and quadruple incisors must mutually correspond to standard or unified symbols.

4.2.8. The permissible deviation of the width of the engraved lines is no more than +/- 0.01 mm.

4.2.9. Tolerances on the dimensions of lines engraved with double, triple and quadruple cutters should not exceed:

For line width +/- 0.02 mm;

For the width of the gap between the lines +/- 0.02 mm;

The variation in thickness of lines engraved with one cutter should not exceed half the tolerance for the width of the line.

4.2.10. Engraving of points and circles must be done without distorting their shapes. The permissible maximum deviation of the roundness of engraved signs is no more than +/- 0.02 mm.

4.2.11. The permissible maximum deviation from the nominal dimensions of diameters and line thicknesses when engraving points and circles is no more than:

+/- 0.03 mm for points and circles;

+/- 0.01 mm for circle line thickness.

4.2.12. The permissible maximum deviation from the nominal dimensions when engraving symbols is +/- 0.02 mm.

4.3. Requirements for drawing devices

4.3.1. Drawing devices and tools must be produced in accordance with OST 68-11 and technical specifications for specific types of devices.

4.4. Requirements for cartometer devices

4.4.1. The curvimeter must have two scales:

metric - with measurement limits from 0 to 100 cm;

inch - with measurement limits from 0 to 39.4 inches.

4.4.2. Scale division price:

metric (cm) - 1.0;

inch (inches) - 0.5;

discreteness of digital curvimeter readings (mm) - 0.5.

4.4.3. The relative error in measuring a straight line segment of at least 50 cm in length should be no more than 0.5%.

4.4.4. Curvimeter dials must be white. Slight shades of light colors are allowed. The strokes and numbers of the metric scale should be black, the inch scale should be red. The color of the arrows is black or dark blue.

4.4.5. The working surface of the idler wheel must have a knurl with blunt edges, ensuring that it rolls on paper without slipping or rolling marks.

4.4.6. The rotation of the idler wheel should be smooth, without jumps or jams.

4.4.7. The design of the curvimeter should ensure ease of use, speed and ease of rolling the deflector wheel over the object being measured.

4.4.8. Planimeters must have the following basic parameters and dimensions: the measurement limit is selected from the range: 300; 500; 1000 sq. cm; the range of changes in the planimeter division price is 0.1 - 0.4 square meters. cm; scale division of the bypass lever is 0.05 mm; digital planimeter reading discreteness - 0.05 or 0.1 square. cm; the error in area measurement is determined from the series +/- 0.2; 0.5; 1.0%.

4.4.9. The index of the bypass magnifying glass, which serves to outline the contour, must be clear. The magnifying glass should provide good visibility of the bypass contour.

4.4.10. When installing the counting mechanism carriage to the desired division, its movement along the bypass lever should be easy and smooth.

4.4.11. The counting roller should have no longitudinal play, and its rotation should be easy and smooth.

4.4.12. No play is allowed in the connection of the pole arm with the support weight and the planimeter carriage.

4.4.13. Digital curvimeters and planimeters must operate from built-in batteries.

4.5. Requirements for instruments for measuring coordinates

4.5.1. The devices must ensure operation in areas of at least 600 x 600 mm. At the customer's request, the devices must ensure operation in areas of formats up to and including AO.

4.5.2. The discreteness of information recording is 0.05 mm.

4.5.3. The permissible maximum error in applying and reading coordinates is +/- 0.1 mm for A2 format and +/- 0.2 mm for large formats.

4.5.4. The magnification of the optical observation system is no less than (2 +/- OD) times.

4.5.5. The design of the device must provide the ability to connect a data recorder (storage device) to it.

4.6. Requirements for cartographic devices for input and output of graphic information

4.6.1. Input devices that convert graphic information into digital or electronic form must provide:

1) reading graphic (photographic) images of the original and their properties (color, saturation, contrast, etc.);

2) preservation of the metric characteristics of the original in accordance with the requirements of the technical specifications for a specific type of input device.

4.6.2. Output devices that convert information from digital or electronic form into graphic form must provide:

1) display of graphic (photographic properties of images (color, saturation, contrast, etc.);

4.6.3. I/O devices that sequentially convert graphic information into digital or electronic form, and then back into graphic form, must provide:

1) reproducibility of the graphic (photographic) properties of the original (color, saturation, contrast, etc.);

2) preservation of the metric characteristics of the original in accordance with the requirements of the technical specifications for the specific type of output cartographic work.

4.6.4. The dimensions of the working field on which a graphic (photographic) image is placed to perform input and output operations are established by the technical specifications of the device, but not less than 600 mm x 900 mm.

4.6.5. Input and output devices must have software to obtain the relative coordinates of points identified appropriately on the original material and on the converted one.

4.6.6. Devices must operate from AC mains or built-in power sources.

4.7. Labeling and packaging

4.7.1. Labeling should be done on the device and packaging. The marking must be applied in a way that ensures its preservation during the period between repairs.

4.7.2. The device labeling must contain:

manufacturer's trademark;

symbol of the device or its name;

year of issue;

serial number according to the manufacturer's system.

4.7.3. Devices must be provided with standard individual packaging in the form of a box, case, cover, envelope or box. The packaging must indicate: the manufacturer's trademark; name of the device, tool or spare parts.

5. Acceptance rules

5.1. To determine the quality of devices, the following types of tests are established:

Acceptance and acceptance;

Periodic;

Typical.

5.2. All devices manufactured by the manufacturer are subject to acceptance tests. Tests are carried out by the technical control department (QC) of the manufacturer.

5.3. Acceptance and periodic tests are carried out in the scope and sequence specified in the technical specifications for specific devices.

5.4. Periodic tests must be carried out at intervals selected from the series 0.5; 1; 3 years.

5.5. Periodic tests are carried out to ensure that the device meets all requirements, including reliability and maintainability.

5.6. Three devices out of those that passed acceptance tests are subjected to periodic testing.

5.7. The result of acceptance and periodic tests is considered positive if the device meets all requirements.

5.8. If the device does not meet at least one requirement, the devices are returned to the manufacturing workshop to determine the reasons for the defect and eliminate the defects.

5.9. After eliminating the defects, rejected devices are presented to the Quality Control Department again. Repeated tests are carried out in full scope of acceptance tests.

5.10. If repeated tests reveal that the device does not comply with the requirements of the specifications, the devices are finally rejected.

5.11. Type tests are carried out by the manufacturer in all cases when changes are made to the design, materials and manufacturing technology that affect the technical characteristics.

5.12. At least 10 devices manufactured with modifications must be presented for type testing.

5.13. If the results of standard tests are positive, the devices can be manufactured according to the modified technological regulations.

5.14. If the results of type tests are negative, the planned changes to the design, materials or technology are not made.

6. Test methods

6.1. Testing of devices and making decisions based on test results is carried out in accordance with the requirements of this standard and technical specifications for devices of specific types. The test methods and means specified in this standard may be replaced by others provided that the required conditions and measurement errors are ensured.

All measuring and testing instruments used must be verified or certified in the prescribed manner.

6.2. All tests, unless the conditions for their conduct are specified in the description of individual methods, should be carried out under the following conditions:

Ambient air temperature - (20 +/- 5) °C;

Relative air humidity - (65 +/- 15)%.

6.3. The list of measuring instruments and equipment required for testing is given in the Appendix.

6.4. Control of cartographic devices for compliance with the requirements of paragraphs 4.1.3, 4.1.4, 4.1.7, 4.2.2 - 4.2.6, 4.4.1, 4.4.2, 4.4.4 - 4.4.7, 4.4.9 - 4.4.13, 4.5.5, 4.6.1 - 4.6.3, 4.6.5 is carried out by external inspection by comparison with design documentation and testing.

6.5. The quality of protective and decorative coatings according to clause 4.1.2 is checked in accordance with the requirements of GOST 9.302, the requirements for quality control of the base metal and coatings are checked in accordance with GOST 9.301.

6.5. The compliance of materials, purchased components with standards and other regulatory and technical documentation according to clause 4.1.5 is established according to the documents for their supply.

6.6. When testing for vibration strength according to clause 4.1.6, the devices in the package are rigidly attached to the table of the vibration stand and tested in a given mode.

6.7. Verification of the requirements according to clauses 4.2.1, 4.2.7, 4.2.8, 4.2.9, 4.2.11, 4.2.12 is carried out by trial engraving with each cutter from the supplied set on an Ozascribe type engraving base located on a clear table , for all cutter stroke values (from 0.6 to 1.2 mm). Check the quality of engraved signs using a LI-3-10x magnifying glass in accordance with GOST 25706. If it is difficult to determine the shape of conventional signs (rectangle, square), visually measure the angles and dimensions of the sides of the signs using a BMI-1Ts microscope in accordance with GOST 8074. Deviations from the nominal values should not exceed those specified in the relevant paragraphs of section 4.

6.8. The requirements under clause 4.2.10 are monitored as follows:

Engrave a circle with any cutter;

Measure the diameter of the circle in four directions using a BMI-1Ts microscope in accordance with GOST 8074;

We obtain the deviation from roundness by subtracting the minimum diameter value from the maximum. The deviation from the nominal value should be no more than 0.02 mm.

6.9. Checking the relative error of the curvimeter according to clause 4.4.3 is determined by the results of measurements with the curvimeter of a straight line segment of at least 0.5 m, previously measured with a line length measure of type IV according to GOST 12069-78. Measuring the length of a segment with a curvimeter must be done at least 6 times.

6.10. Check the control of the main parameters according to clause 4.4.8 using a ruler in accordance with GOST 427, a measuring magnifying glass in accordance with GOST 25706, a micrometer in accordance with GOST 6507.

To determine the error in area measurement, bring the planimeter into working condition in accordance with the ED. Make 6 contours of an area of 100 square meters. cm, recording the readings after each of them, and calculate the error m using the formula:

______________ m = \/SUM DELTA / n where: DELTA = P - P 0 i, n - number of measurements, P - values of the measured area.

6.11. Check the dimensions of the working area of the coordinateograph according to clauses 4.5.1, 4.6.4 by measuring the coordinate values of the extreme points along each of the axes.

6.12. Check the discreteness of information registration according to clause 4.5.2 when outputting information (for cartometers - to a computer).

6.13. The error in reading the coordinates of points according to clause 4.5.3 can be checked by comparing the results of measuring the coordinates of control grid points with the certified values of the coordinates of these points. The control grid must be certified on equipment that has a measurement error of no more than 0.01 mm.

6.14. The enlargement of the optical observation system according to clause 4.5.4 should be carried out by comparing the value of the selected interval S2 on the second scale with its enlarged image S1 on the first scale. The ratio of these quantities determines the magnification of the viewing device F = S1 / S2.

6.15. Safety and maintainability control - in accordance with the specifications for specific types of devices.

7. Transportation and storage

7.1. For transportation, devices must be packaged in transport containers that ensure the safety of products and individual packaging during transportation.

7.2. Marking of transport containers in accordance with GOST 14192 with the obligatory application of handling signs and warning notices about the methods of handling the cargo.

7.3. The weight of one piece of transport container when fully loaded with instruments should not exceed 50 kg.

7.4. The storage conditions for devices in transport containers or individual packaging in terms of exposure to environmental climatic factors must comply with category 4 according to GOST 15150.

7.5. When stored for more than 6 months. devices must be preserved according to group 11-3 GOST 9.014.

8. Operating instructions

8.1. During operation, devices must be protected from dust, moisture, shock and shaking.

8.2. Cleaning devices with substances that damage coatings is not allowed.

8.3. During operation, devices must be lubricated at least once every six months with OKB-122-5 grease in accordance with GOST 18179.

8.4. It is necessary to carry out routine maintenance as specified in the operating instructions for certain types of devices.

8.5. During operation, measuring instruments for cartographic purposes must undergo periodic calibration through a calibration interval established by the metrological service.

9. Manufacturer's warranty

9.1. The manufacturer guarantees trouble-free operation of the devices provided that the consumer complies with the operating, transportation and storage conditions established by this standard, technical specifications and operating instructions for certain types of devices.

9.2. Warranty periods are established in the technical specifications for certain types of devices.

Application

┌────────────────────────────────────┬─── ───────── ───────────────┐ │ Name │ Type or designation │ ├───────────────── ───────── Lie metal neck │Ruler-1000 │ │ │GOST 427-75 │ ├──────────────────────────────────── ┼──────── │ │ │ GOST 25706-83 │ ├─── ───────── ────────────────────────┼──────────────── ───────── ──┤ │Micrometer │GOST 6507-90 │ ├─────────────────────────── ────────┼─ ──────────────────────────┤ │Control grid │ │ ├────── ─────────── ───────────────────┼───────────────────── ──────┤ │Microscope instrumental │GOST 8074-82 │ ├───────────────────────────────── ───┼───── ──────────────────────┤ │Microscope with measuring attachment │TU 3-3.2048-88 │ ├──── ───────── ───────────────────────┼───────────────── ───────── ─┤ │Densitometer │DP-1, DP-2 │ │ │MI 716-85, MI 1225-86 │ ├─────────────────── ───── ────────────┼───────────────────────────┤ │Test object │Non-standardized │ └─ ───────────────────────────────────┴───── ───────── ─────────────┘

ConsultantPlus: note It is allowed to use other measuring instruments that provide the required accuracy.

Methods, means and modes. The main differences between technical characteristics, state and industry standards Application of OST

State standard

Specifications

Industry standard

ORDER dated June 10, 1985 N 770

ON THE INTRODUCTION OF THE INDUSTRY STANDARD OST 42-21-2-85 "STERILIZATION AND DISINFECTION OF MEDICAL DEVICES. METHODS, MEANS AND REGIMES"

APPROVAL SHEET

MINISTRY OF HEALTH OF THE USSR

INDUSTRY STANDARD STERILIZATION AND DISINFECTION OF MEDICAL DEVICES METHODS, MEANS AND MODES OST 42-21-2-85

UDC 614.48 Group R 08

INDUSTRY STANDARD

STERILIZATION AND DISINFECTION OF MEDICAL DEVICES

METHODS, MEANS AND MODES

1. General Provisions

2. Pre-sterilization cleaning

3. Sterilization

4. Disinfection

Industry Standards (OST)

Technical conditions (TU)

SCROLL INSTRUCTIONAL AND METHODOLOGICAL DOCUMENTS ON STERILIZATION AND DISINFECTION

Table 1. Pre-sterilization cleaning

Table 2. Preparation of detergent

Table 3. Chemical cleaning of stainless steel surgical instruments

Table 4. Steam sterilization method (saturated water steam under excess pressure)

Table 5. Air sterilization method (dry hot air)

Table 6. Chemical sterilization method (chemical solutions)

Table 7. Chemical sterilization method (gas) sterilization with a mixture of OB and ethylene oxide

Table 8. Chemical sterilization method (gas) sterilization with a mixture of water vapor and Formaldehyde

Table 9. Disinfection of medical devices*

Regulatory and technical documentation for chemical reagents and auxiliary materials

List of instructional and methodological documents on sterilization and disinfection

. General provisions

INDUSTRY STANDARD

INDUSTRY SYSTEM OF OCCUPATIONAL SAFETY STANDARDS. BASIC POINTS

OST 68-12.0.01-02

INDUSTRY STANDARD

CARTOGRAPHIC DEVICES. GENERAL TECHNICAL CONDITIONS

OST 68-16-02

ORDER
dated June 10, 1985 N 770

INDUSTRY STANDARD
STERILIZATION AND DISINFECTION OF MEDICAL DEVICES METHODS, MEANS AND MODES OST 42-21-2-85

SCROLL
INSTRUCTIONAL AND METHODOLOGICAL DOCUMENTS ON STERILIZATION AND DISINFECTION