Rospotrebnadzor order 770 of 1985. Methods, means and regimes
INDUSTRY STANDARD
STERILIZATION AND DISINFECTION OF MEDICAL DEVICES
Methods, means and modes
(instead of OST 42-2-2-77)
The term of introduction is set from 01.01.86
DEVELOPED by the All-Union 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., Ioyrish A.P., Kopylova L.S., Troshin K.A., Yuzbashev V.G.
All-Union Scientific Research and Testing Institute of Medical Equipment (VNIIIMG)
Director of the Institute Leonov B.I.
Performers: Teresheneov A.I., Rybchinskaya N.A.
AGREED:
Main Directorate of Quarantine Infections of the Ministry of Health of the USSR
Head of Department Sergiev V.P.
PREPARED FOR APPROVAL
Department for the introduction of new drugs and medical equipment of the Ministry of Health of the USSR
Head of Department Babayan E.A.
APPROVED
USSR Ministry of Health
Deputy Minister Shchepin O.P.
INTRODUCED
Order of the Ministry of Health of the USSR N 770 of June 10, 1985
FIXED
Behind the All-Union Research Institute of Disinfection and Sterilization (VNIIDiS) and
All-Union Scientific Research and Testing Institute of Medical Equipment (VNIIIMT)
Registered and listed state registration 07/12/85 N 8355618
Failure to comply with the standard is punishable by law.
This standard applies to medical devices subjected to sterilization and (or) disinfection during operation.
The standard is mandatory for institutions operating medical devices, as well as for organizations and enterprises that develop and manufacture medical devices.
The standard does not apply to medicinal products and their packaging, to products manufactured by the industry as sterile, to products made of 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).
List of regulatory and technical documents for chemical reagents and supporting materials is given in reference Appendix No. 1 to this standard.
The list of instructive and methodological documents of the USSR Ministry of Health on sterilization and disinfection is given in Reference Appendix No. 2 to this standard.
1. General Provisions
I. General provisions
1.1. The methods, means and modes of pre-sterilization cleaning, sterilization and disinfection established in this standard are equivalent in terms of effectiveness for each type of treatment.
Note. Preference should be given to thermal methods of sterilization (steam and air).
1.2. Based on the provisions of this standard, instructions should be developed that establish 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 should be selected based on the resistance of products to 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 indicators of the product; 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 should be standardized in the technical specifications (medical and technical requirements) for the development of new products, specifications, standards, as well as indicated in the operational documentation and must be controlled at the stage of development and manufacture of the product.
In the technical specifications, in the standards for mass-produced products, the requirement for the 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 specific types products, as well as operational documentation.
1.6. The requirements of technical documentation (including operational) in terms of 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, they must be agreed with the Office for the Introduction of New Medicines and medical equipment of the Ministry of Health of the USSR.
1.7. When conducting pre-sterilization cleaning, sterilization and disinfection by a chemical method (with the exception of gas sterilization), disinfection by boiling, it is allowed to use inhibitors and other additives that help reduce corrosion, permitted by the USSR Ministry of Health and do not reduce the effectiveness of pre-sterilization cleaning, sterilization and disinfection.
1.8. Sterility control should be carried out by bacteriological laboratories of sanitary and epidemiological stations and medical and preventive institutions in accordance with the instructions approved by the USSR Ministry of Health.
1.9. The operation of sterilizers is controlled by disinfection stations and disinfection departments (departments) of sanitary-epidemiological stations in accordance with the instructions approved by the USSR Ministry of Health.
1.10. Quality control of pre-sterilization cleaning and de-infection should be carried out by medical institutions, sanitary-epidemiological and disinfection stations in accordance with the instructions approved by the USSR Ministry of Health.
2. Pre-sterilization cleaning
2.1. All products should be subjected to pre-sterilization cleaning before their sterilization in order to remove protein, fat and mechanical contaminants, as well as drugs.
2.2. Detachable products must be subjected to pre-sterilization cleaning in disassembled form.
2.3. Pre-sterilization cleaning should be carried out manually or mechanized (using special equipment) method.
2.4. Mechanized pre-sterilization cleaning should be carried out by jet, rotary methods, brushing or using ultrasound using surfactants according to clause 18 of this standard and other additives.
The procedure for mechanized cleaning must comply with the operating instructions supplied with the equipment.
Note. Ruffing of rubber products is not allowed.
2.5. Pre-sterilization cleaning by hand should be carried out in sequence in accordance with Table 1.
2.6. When using a cleaning solution containing 0.5% hydrogen peroxide and 0.5% Lotus detergent, a corrosion inhibitor is used - 0.14% sodium oleate.
2.7. At the end of the work shift, the equipment must be mechanically cleaned by washing with detergents.
2.8. The washing solution should include components in accordance with Table 1
2.9. Instruments during operation, pre-sterilization cleaning, sterilization may be subject to corrosion. Tools with visible corrosion spots, as well as with the presence of an oxide film, are subjected to chemical cleaning no more than 1-2 times per quarter.
3. Sterilization
3.1. All products in contact with the wound surface, in contact with blood or injectable drugs, and certain types of medical instruments that come into contact with the mucous membrane during operation and can cause damage to it should be sterilized.
3.2. Sterilization should be carried out by one of the methods given in Tables 4-8.
Table 1. Pre-sterilization cleaning
|
Cleaning mode |
||||||
|
Cleaning processes |
Initial |
holding time, |
hired |
|||
|
nomi- |
pre- |
nomi- |
pre- |
|||
|
Immersion of instruments contaminated with blood in a solution of corrosion inhibitors (1% of their use during surgery or manipulation) |
Taz, |
|||||
|
Rinsing with running water |
Bath, |
|||||
|
Soak |
when applying |
Tank, bath, cancer |
||||
|
complete |
when applying |
|||||
|
* The temperature of the solution during the washing process is not maintained. |
||||||
|
Washing each product in a washing solution (p. 2.8) using a brush or cotton-gauze swab |
||||||
|
when applying |
Bath, |
|||||
|
Rinsing |
when applying |
for |
||||
|
when applying |
||||||
|
Rinsing with distilled water |
Tank, bath |
|||||
|
Hot air drying |
Before |
Sushil- |
||||
|
news |
||||||
Notes: 1. If an instrument contaminated with blood can be washed under running water immediately after being used in an operation or manipulation, do not immerse it in a corrosion inhibitor solution (sodium benzoate).
2. If necessary (duration of operation), the instrument can be left immersed in a corrosion inhibitor solution (sodium benzoate) for up to 7 hours.
3. The washing solution may be used before contamination (until a pink color appears, which indicates that the solution is contaminated with blood, which reduces the cleaning efficiency). Detergent 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 mode of drying of endoscopes and products made of natural latex, as well as the requirements for immersion of endoscopes in solutions should be set out in the instructions for use of these products.
Table 2. Preparation of cleaning solution
|
Name of components |
Quantity |
Applicability |
|
Detergent "Biolot", g |
Applicable for |
|
|
Water, drinking, cm |
(jet method, brushing, |
|
|
Detergent "Biolot", g |
Applicable for |
|
|
Drinking water, cm |
rotary cleaning |
|
|
Detergent "Biolot", g |
Applicable for |
|
|
Drinking water, cm |
manual cleaning |
|
|
Hydrogen peroxide solution*, cm |
Applicable for |
|
|
Detergent: "Progress", "Aina", "Astra", "Lotus" *, g |
(jet method, brushing, |
|
|
Drinking water, cm |
manual cleaning |
|
|
_______________ |
||
|
Detergent "Lotus", g |
Applicable for |
|
|
Drinking water, cm |
||
In Russia, all institutions involved in medical activities are required to work according to strict standards, among which an important place is occupied by the proper disinfection and sterilization of medical devices.
Why comply with the standard
Today, many people, even far from medicine, are familiar with such a term as nosocomial infection. It includes any disease that the patient receives either as a result of his seeking help from a medical institution, or the organization's personnel in the performance of their functional duties. According to statistics, in surgical hospitals the level of purulent-inflammatory complications after clean operations is 12-16%, in gynecological departments complications after operations develop in 11-14% of women. After studying the structure of the incidence, it became obvious that from 7 to 14% of newborns become infected in maternity hospitals and children's departments.
Of course, such a picture can not be observed in all medical organizations and their prevalence depends on many factors, such as the type of institution, the nature of care provided, the intensity of transmission mechanisms for nosocomial infections, and its structure. Against this background, one of the main non-specific measures to prevent the occurrence and transmission of nosocomial infection is the disinfection and sterilization of medical devices.
Regulations
In their work, all health facilities are guided by the recommendations recorded in many regulatory documents. The fundamental document is SanPiN (disinfection and sterilization of medical devices is highlighted in a separate section). The latest revision was approved in 2010. Also, the following regulatory acts determine the work of medical institutions.
- Federal Law No. 52, which declares measures for the epidemiological safety of the population.
- Order No. 408 (on viral hepatitis) dated 07/12/1984.
- Order No. 720 (on combating nosocomial infections).
- Order of 09/03/1999 (on the development of disinfection).
OST "Sterilization and disinfection of medical devices" No. 42-21-2-85 is also one of the main documents regulating the standard for processing instruments. It is they who are guided by all medical institutions in their work.
In addition, there is a large number of disinfection and sterilization of medical devices in which it is considered in terms of various disinfectants approved for this purpose. Today, due to the fact that many dis. funds corresponding guidelines are also an integral part of the documents on which the work of health care facilities is based. To date, the processing of instruments consists of three successive stages - disinfection, PSO and sterilization of medical devices.
Disinfection
Disinfection is a complex of measures, as a result of which pathogenic microorganisms are destroyed in environmental objects. These include surfaces (walls, floors, windows, hard furniture, equipment surfaces), patient care items (linen, dishes, sanitary equipment), as well as body fluids, patient secretions, etc.
In the identified focus of infection, activities called "focal disinfection" are carried out. Its purpose is the destruction of pathogens directly in the identified focus. Allocate the following types focal disinfection:
- current - it is it that is carried out in medical institutions in order to prevent the spread of infection;
- the final one is carried out after being isolated, that is, the sick person was hospitalized.
In addition, there is preventive disinfection. Its activities are carried out constantly, regardless of the presence of an infectious focus. It includes washing hands, cleaning surrounding surfaces with the help of products that have bactericidal additives.
Disinfection methods
Depending on the goals, the following methods of disinfection are used:
- mechanical: it refers directly to the mechanical impact on the object - wet cleaning, shaking or knocking out bedding- it does not destroy pathogenic microorganisms, but only temporarily reduces their number;
- physical: exposure to ultraviolet, high or low temperatures - in this case, destruction occurs in case of exact observance of the temperature regime and exposure time;
- chemical: destruction of pathogenic microorganisms with the help of chemicals - immersion, wiping or spraying the object with a chemical solution (is the most common and effective method);
- biological- in this case, an antagonist of the microorganism that needs to be destroyed is used (most often used at specialized bacteriological stations);
- combined- combines several methods of disinfection.
OST "Sterilization and disinfection of medical devices" 42-21-2-85 states that all objects and instruments with which the patient had contact must go through the disinfection process. In healthcare facilities, a physical or chemical method of disinfection is used for this. After its completion, the products, depending on their purpose, are further processed, disposed of or reused.
Pre-sterilization cleaning
Disinfection and sterilization of medical devices for reusable instruments to be sterilized also provides for pre-sterilization cleaning, which takes place after the disinfection of the product. The purpose of this stage is the final mechanical removal of residues of fatty and protein contaminants, as well as medicines.
The new SanPiN, which deals with disinfection and sterilization of medical devices in sufficient detail, provides for the following stages of PSO.
- Within 0.5 minutes, the product is washed under running water to remove the remnants of the disinfectant solution.
- In a washing solution, for the manufacture of which only approved products are used, the products are soaked in full immersion. In the event that they consist of several parts of the product, it is necessary to disassemble and make sure that all existing cavities are filled with a solution. At a washing solution temperature of 50º, the exposure time is 15 minutes.
- After the time has elapsed, each product is washed with a ruff or gauze swab for 0.5 minutes in the same solution.
- Rinse under the products. The duration of rinsing depends on the product used ("Astra", "Lotus" - 10 minutes, "Progress" - 5, "Biolot" - 3).
- Rinse in distilled water for 30 seconds.
- Drying in ovens with hot air.
To prepare a washing solution, use 5 g of SMS ("Progress", "Astra", "Lotos", "Biolot"), 33% perhydrol - 16 g, or 27.5% - 17 g. It is also allowed to use 6% (85 g ) and 3% (170 g) hydrogen peroxide, drinking water - up to 1 liter.
Modern means used for disinfection make it possible to combine the processes of disinfection and PSO. In this case, after the end of the exposure, directly in the des. solution, the tools are brushed and then all subsequent stages of the PSO are carried out.
Quality control
JV, disinfection and sterilization of medical devices, which are painted literally step by step, pay great attention to the quality control of each stage of processing. To do this, tests are carried out that control the absence of blood, other protein compounds on the processed product, as well as the quality of washing off detergents. One percent of the processed instrumentation is subjected to control.
The phenolphthalein test allows you to evaluate how carefully the products were removed detergents used for pre-sterilization cleaning. To put it on a swab, apply a small amount of a ready-made 1% solution of phenolphthalein and then wipe those products that they want to check. If a pink coloration appears, the quality of washing off of detergents is considered insufficient.
Disinfection and sterilization of medical devices require control at each stage, and another test that allows you to assess how well the first stages were carried out is the azopyram test. It evaluates the presence or absence of blood and medicinal substances on them. To carry it out, you will need a solution of azopyram, which, when prepared, can be stored for 2 months in the refrigerator (at room temperature, this period is reduced to one month). Some turbidity of the reagent in the absence of sediment does not affect its quality.
For the test, immediately before it is carried out, the same amount of azopyram and 3% hydrogen peroxide are mixed and applied to the blood spot for verification. The appearance of a purple color means that the reagent is working - you can start testing. To do this, moisten a swab with the prepared reagent and wipe the surfaces of tools and equipment. In products with hollow channels, a few drops of the reagent are placed inside and after 1 minute the result is evaluated, paying special attention to the joints. In the event that a purple color appears, gradually turning into a pink-lilac color, the presence of blood is ascertained. Brownish color indicates the presence of rust, and purple - chlorine-containing substances.
For correct assessment The results of the azopyram test must take into account several points:
- a positive sample is considered only if the staining appeared within the first minute after applying the reagent;
- the working solution can only be used within the first two hours after preparation;
- products must be at room temperature (on a hot surface, the sample will be uninformative);
- regardless of the results, the products on which the test was carried out are washed with water and again subjected to presterization cleaning.
If positive results are obtained after testing, the entire batch is re-treated until a negative result is obtained.
Sterilization
Sterilization is the final step in the treatment of those products that have contact with the wound surface, mucous membrane or blood, as well as injectable drugs. In this case, there is a complete destruction of all forms of microorganisms, both vegetative and spore. Carrying out all manipulations in this case is regulated in detail by such normative document MZ, as an order. Sterilization and disinfection of medical devices are carried out according to the specifics of the medical institution and their purpose. Sterilized products can be stored, depending on the packaging, from a day to six months.
Sterilization Methods
Methods for disinfection and sterilization of medical devices are somewhat different from each other. Sterilization is carried out by the following methods:
- thermal - air, steam, glasperleny;
- chemical - gas or in solutions of chemicals;
- plasma or ozone;
- radiation.
In medical institutions, as a rule, steam, air or chemical methods are used. At the same time, the most important component of the sterilization process is the careful observance of the established regimes (time, temperature, pressure). The mode of disinfection and sterilization of medical devices is selected depending on the material from which the processed product is made.
air method
In this way, medical instruments, parts of apparatuses and devices made of metal, glass are sterilized. Before the sterilization cycle, the products must be thoroughly dried.
The maximum deviation from this method of sterilization should not exceed 3°C.
Steam method
The steam method is by far the most widely used, which is associated with a short cycle, the possibility of using it to sterilize products made from non-heat-resistant materials (linen, suture and rubber, plastic, latex products). Sterility in this method is achieved through the use of steam supplied under excessive pressure. This happens in a steam sterilizer or in an autoclave.
Deviations in pressure modes are allowed up to 2 kg / m², and temperature conditions - 1-2 °.
Glasperlen sterilization
Technical support of medical institutions for last years improved significantly and this is noted in the latest SP (disinfection and sterilization of medical devices). A new one that has become widely used in healthcare facilities is glasperlene sterilization. It consists in immersing the instrumentation in the medium of glass granules heated to 190 - 330 °. The sterilization process takes minutes, and then the instrumentation is ready for use. The disadvantage of this method is that only small instruments can be secured with it, so it is used mainly in dental departments.
Disinfection, pre-sterilization cleaning, sterilization of medical devices are essential elements in the work of modern hospitals. From how carefully all the activities that are enshrined in regulations approved by the Ministry of Health of the Russian Federation, the health of both patients and medical personnel will depend.
INDUSTRY STANDARD
STERILIZATION AND DISINFECTION
MEDICAL DEVICES
METHODS, TOOLS AND REGIMES
OST 42-21-2-85
DEVELOPED by the All-Union 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.,
Ioyrish A.N., L.S. Troshin K.A., Yuzbashev V.G.
All-Union Scientific Research and Testing Institute of Medical Equipment (VNIIIMG)
Director of the Institute Leonov B.I.
Performers: Tereshenkov A.I., Rybchinokaya N.A.
AGREED:
Main Directorate of Quarantine Infections of the Ministry of Health of the USSR
Head of Department Sergiev V.P.
PREPARED FOR APPROVAL
Department for the introduction of new drugs and medical equipment of the Ministry of Health of the USSR
Head of Department Babayan E.A.
APPROVED
USSR Ministry of Health
Deputy Minister Shchepin O.P.
INTRODUCED
FIXED
Behind the All-Union Research Institute of Disinfection and Sterilization (VNIIDiS) and
All-Union Scientific Research and Testing Institute of Medical Equipment (VNIIIMT)
Registered and entered in the register of state registration 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.
Non-compliance with the standard is punishable by law
This standard applies to medical devices subjected to sterilization and (or) disinfection during operation.
The standard is mandatory for institutions operating medical devices, as well as for organizations and enterprises that develop and manufacture medical devices.
The standard does not apply to medicinal products and their packaging, to products manufactured by the industry as sterile, to products made of 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 normative and technical documents for chemical reagents and auxiliary materials is given in the reference appendix to this standard.
The list of instructive and methodological documents of the USSR Ministry of Health on sterilization and disinfection is given in the reference appendix to this standard.
. General provisions
. Disinfection
Pre-sterilization cleaning
|
Cleaning mode |
Applied equipment |
Holding time, min |
nominal value |
limit deviation |
nominal value |
limit 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 |
Bathtub, sink |
Soaking in a cleaning solution (p. ) with the product completely immersed |
Tank, bathtub, sink |
when using detergents "Progress", "Astra", "Lotus", "Aina" |
Washing each product in a washing solution (p.) with a brush or cotton-gauze swab |
Rinsing under running water |
when using detergent "Biolot" |
Bathtub, sink with water jet |
when using detergent "Progress" |
when using detergents "Astra", "Lotus", "Aina" |
Rinsing with distilled water |
Tank, bath |
Hot air drying |
until the complete disappearance of moisture |
drying cabinet |
* The temperature of the solution during the washing process is not maintained Notes. 1. If an instrument contaminated with blood can be washed under running water immediately after use in an operation or manipulation, do not immerse it in a corrosion inhibitor solution (sodium benzoate). 2. If necessary (duration of operation), the instrument can be left immersed in a corrosion inhibitor solution (sodium benzoate) for up to 7 hours. 3. The washing solution may be used before contamination (until a pink color appears, which indicates that the solution is contaminated with blood, which reduces the cleaning efficiency). Detergent 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 mode of drying of endoscopes and products made of natural latex, as well as the requirements for immersion of endoscopes in solutions, should be set out in the instructions for use of these products. |
Detergent preparation
|
The number of components for the preparation of 1 dm3 of cleaning solution |
Applicability |
Detergent "Biolot", g |
It is used for mechanized cleaning (jet method, brushing, use of ultrasound) |
Drinking water, cm3 |
Detergent "Biolot", g |
It is used for mechanized cleaning by the rotary method. |
Drinking water, cm3 |
Detergent "Biolot", g |
Used for manual cleaning |
Drinking water, cm3 |
Hydrogen peroxide solutionx, cm3 |
It is used for mechanized (jet method, brushing, use of ultrasound) and manual cleaning |
Detergent |
("Progress", "Aina", "Astra", |
"Lotus") xx, g |
Drinking water, cm3 |
Detergent "Lotus", g |
Used for mechanized cleaning using ultrasound |
Drinking water, cm |
x - For pre-sterilization cleaning, it is allowed to use medical hydrogen peroxide, as well as technical hydrogen peroxide grades A and B. The amounts of hydrogen peroxide given in the table are calculated for a solution with a concentration of 27.5%.
xx - Organizations that develop and manufacture medical devices when checking the resistance of products to pre-sterilization cleaning agents should use hydrogen peroxide solutions with detergents.
Chemical cleaning of stainless steel surgical instruments
|
Cleaning mode |
Applied equipment |
Initial solution temperature, °С |
Holding time, min |
nominal value |
limit deviation |
nominal value |
limit deviation |
Pre-rinsing with running water |
Bathtub, sink |
Soaking in solution: |
Enameled, glass, polyethylene container with lid |
acetic acid - 5 g |
(conversion to 100%) |
sodium chloride - 1 g |
distilled water - |
Washing with running water |
Bathtub, sink |
Sheet, diaper, towel |
x For stainless steel scalpels.
xx For tools with an oxide film.
xxx For instruments with severe corrosion lesions, it is recommended to additionally clean the lesions with a ruff or cotton-gauze swab.
Steam sterilization method (saturated water steam under pressure)
|
Applicability |
Shelf life of sterility |
Applied equipment |
Steam pressure in the sterilization chamber, MPa (kgf/cm2) |
Sterilization exposure time, min |
with manual and floor automatic control, not less |
With automatic control |
nominal value |
limit value |
nominal value |
limit value |
nominal value |
limit deviation |
Sterilization is carried out in sterilization boxes without filters or in sterilization boxes with a filter, or in double soft packaging made of coarse calico, parchment, unimpregnated bag paper, wet-strength bag paper, paper for packaging products on brand E machines (density polyethylene, PVC plastic compounds) |
The shelf life of products sterilized in sterile boxes without filters, in double soft packaging made of coarse calico or parchment, unimpregnated paper, bag paper for packaging products on brand E machines, is t3 days, in sterilization boxes with a filter 20 days |
Steam sterilizer |
Air sterilization method (dry hot air)
|
Applicability |
Conditions for sterilization |
Shelf life of sterility |
Applied equipment |
Working temperature in the sterilization chamber, °C |
Holding time, min |
nominal value |
limit deviation |
nominal value |
limit deviation |
Sterilization is subjected to dry products. Sterilization is carried out in packaging made of unimpregnated sack paper, wet-strength sack paper, paper for packaging products on brand E machines or without packaging (in open containers) |
Products sterilized in unimpregnated sack paper and wet-strength sack paper, paper for packaging products on brand E 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)
x Hydrogen peroxide solution can be used within 7 days from the date of preparation, provided that it is stored in a closed container in a dark place. Further use of the solution can be carried out only if the content of active substances is controlled. xx The temperature of the solution during the sterilization process is not maintained. xxx Deoxon-1 solution can be used within one day. xxxx Organizations that develop and manufacture products when testing the resistance of products to sterilization agents may use non-sterile water. Chemical sterilization method (gas) sterilization with a mixture of OB and ethylene oxide
Chemical sterilization method (gas) sterilization with a mixture of water vapor and formaldehyde
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INDUSTRY STANDARD
STERILIZATION AND DISINFECTION
MEDICAL DEVICES
METHODS, TOOLS AND REGIMES
OST 42-21-2-85
DEVELOPED by the All-Union 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.,
Ioyrish A.N., L.S. Troshin K.A., Yuzbashev V.G.
All-Union Scientific Research and Testing Institute of Medical Equipment (VNIIIMG)
Director of the Institute Leonov B.I.
Performers: Tereshenkov A.I., Rybchinokaya N.A.
AGREED:
Main Directorate of Quarantine Infections of the Ministry of Health of the USSR
Head of Department Sergiev V.P.
PREPARED FOR APPROVAL
Department for the introduction of new drugs and medical equipment of the Ministry of Health of the USSR
Head of Department Babayan E.A.
APPROVED
USSR Ministry of Health
Deputy Minister Shchepin O.P.
INTRODUCED
FIXED
Behind the All-Union Research Institute of Disinfection and Sterilization (VNIIDiS) and
All-Union Scientific Research and Testing Institute of Medical Equipment (VNIIIMT)
Registered and entered in the register of state registration 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.
Non-compliance with the standard is punishable by law
This standard applies to medical devices subjected to sterilization and (or) disinfection during operation.
The standard is mandatory for institutions operating medical devices, as well as for organizations and enterprises that develop and manufacture medical devices.
The standard does not apply to medicinal products and their packaging, to products manufactured by the industry as sterile, to products made of 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 normative and technical documents for chemical reagents and auxiliary materials is given in the reference appendix to this standard.
The list of instructive 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 |
Applied equipment |
Holding time, min |
nominal value |
limit deviation |
nominal value |
limit 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 |
Bathtub, sink |
Soaking in a cleaning solution (p. ) with the product completely immersed |
Tank, bathtub, sink |
when using detergents "Progress", "Astra", "Lotus", "Aina" |
Washing each product in a washing solution (p.) with a brush or cotton-gauze swab |
Rinsing under running water |
when using detergent "Biolot" |
Bathtub, sink with water jet |
when using detergent "Progress" |
when using detergents "Astra", "Lotus", "Aina" |
Rinsing with distilled water |
Tank, bath |
Hot air drying |
until the complete disappearance of moisture |
drying cabinet |
* The temperature of the solution during the washing process is not maintained Notes. 1. If an instrument contaminated with blood can be washed under running water immediately after use in an operation or manipulation, do not immerse it in a corrosion inhibitor solution (sodium benzoate). 2. If necessary (duration of operation), the instrument can be left immersed in a corrosion inhibitor solution (sodium benzoate) for up to 7 hours. 3. The washing solution may be used before contamination (until a pink color appears, which indicates that the solution is contaminated with blood, which reduces the cleaning efficiency). Detergent 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 mode of drying of endoscopes and products made of natural latex, as well as the requirements for immersion of endoscopes in solutions, should be set out in the instructions for use of these products. |
Detergent preparation
|
The number of components for the preparation of 1 dm 3 washing solution |
Applicability |
Detergent "Biolot", g |
It is used for mechanized cleaning (jet method, brushing, use of ultrasound) |
Drinking water, cm 3 |
Detergent "Biolot", g |
It is used for mechanized cleaning by the rotary method. |
Drinking water, cm 3 |
Detergent "Biolot", g |
Used for manual cleaning |
Drinking water, cm 3 |
Hydrogen peroxide solution x, cm 3 |
It is used for mechanized (jet method, brushing, use of 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 |
x - For pre-sterilization cleaning, it is allowed to use medical hydrogen peroxide, as well as technical hydrogen peroxide grades A and B. The amounts of hydrogen peroxide given in the table are calculated for a solution with a concentration of 27.5%.
xx - Organizations that develop and manufacture medical devices when checking the resistance of products to pre-sterilization cleaning agents should use hydrogen peroxide solutions with detergents.
Chemical cleaning of stainless steel surgical instruments
|
Cleaning mode |
Applied equipment |
Initial solution temperature, ° С |
Holding time, min |
nominal value |
limit deviation |
nominal value |
limit deviation |
Pre-rinsing with running water |
±0.1 |
Bathtub, sink |
Soaking in solution: |
±1.0 |
Enameled, glass, polyethylene container with lid |
acetic acid - 5 g |
±1.0 |
(conversion to 100%) |
sodium chloride - 1 g |
distilled water - |
Washing with running water |
±0.1 |
Bathtub, sink |
Sheet, diaper, towel |
x For stainless steel scalpels.
xx For tools with an oxide film.
xxx For instruments with severe corrosion lesions, it is recommended to additionally clean the lesions with a ruff or cotton-gauze swab.
Steam sterilization method (saturated water steam under pressure)
|
Applicability |
Shelf life of sterility |
Applied equipment |
Steam pressure in the sterilization chamber, MPa (kgf / cm 2) |
Sterilization exposure time, min |
with manual and semi-automatic control, not less than |
With automatic control |
nominal value |
limit value |
nominal value |
limit value |
nominal value |
limit 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 coarse calico, parchment, unimpregnated bag paper, wet-strength bag paper, paper for packaging products on brand E machines (density polyethylene, PVC plastic compounds) |
The shelf life of sterility of products sterilized in sterile boxes without filters, in double soft packaging made of coarse 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 |
Shelf life of sterility |
Applied equipment |
Operating temperature in the sterilization chamber, ° С |
Holding time, min |
nominal value |
limit deviation |
nominal value |
limit deviation |
Sterilization is subjected to dry products. Sterilization is carried out in packaging made of unimpregnated sack paper, wet-strength sack paper, paper for packaging products on brand E machines or without packaging (in open containers) |
Products sterilized in unimpregnated sack paper and wet-strength sack paper, paper for packaging products on brand E 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)
x Hydrogen peroxide solution can be used within 7 days from the date of preparation, provided that it is stored in a closed container in a dark place. Further use of the solution can be carried out only if the content of active substances is controlled. xx The temperature of the solution during the sterilization process is not maintained. xxx Deoxon-1 solution can be used within one day. xxxx Organizations that develop and manufacture products when testing the resistance of products to sterilization agents may use non-sterile water. Chemical sterilization method (gas) sterilization with a mixture of OB and ethylene oxide
Chemical sterilization method (gas) sterilization with a mixture of water vapor and formaldehyde
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Disinfection, sterilization of medical supplies
Sterilization and disinfection of medical devices. Methods, means and modes
1) Disinfection, sterilization of medical devices according to orders No. 770 and No. 408:
pre-disinfection in a separate container;
disinfection;
test for traces of chlorine-containing agents;
pre-sterilization treatment:
■ preparation of cleaning solution,
■ new detergents,
■ disinfectants used for disinfection and pre-sterilization cleaning at the same time;
control of pre-sterilization cleaning; sterilization:
■ definition, device, tasks of the CSO.
■ types of sterilization.
2) Prevention of occupational infection in the treatment room.
3) Cleaning the treatment room.
4) Disposal of disposable products.
5) Disinfection measures for medical supplies.
6) Device of steam sterilizer, air sterilizer.
Medical devices in contact with the wound surface, in contact with blood, injection drugs or mucous membranes of patients after preliminary disinfection, pre-sterilization cleaning, are subject to mandatory sterilization. Today, the industry standard (OST 42-21-2-85) is in force, which defines methods, means and modes of disinfection, sterilization of medical devices, fixed by order No. 770 of the Ministry of Health of the USSR of 06/10/1985 ᴦ., which was supplemented by order No. 408 of 07/12/89.
Failure to comply with the standard is punishable by law.
This standard applies to medical devices subjected to sterilization and (or) disinfection during operation.
The standard is mandatory for institutions operating medical devices, as well as for organizations and enterprises that develop and manufacture medical devices.
The standard establishes methods, means, modes of disinfection, pre-sterilization cleaning and sterilization.
There are three stages in the processing of medical devices:
I stage - disinfection;
II stage - pre-sterilization cleaning;
III stage - sterilization.
Order No. 408 provides for the preliminary rinsing of medical devices that have cavity, capillary in a separate container with water.
Wash water is disinfected by boiling for 30 minutes. or fall asleep with dry bleach 200 g per 1 liter with an exposure of 60 minutes, after which the water can be drained into the sewer.
All healthcare facilities operate by combining orders No. 770 and No. 408.
STAGE I - DISINFECTION
1 . Pre-rinsing in a separate container (water).
2. Disinfection in des. solution. The exposure time depends on the disinfectant used. solution and infection (see table 3).