SanPiN: disinfection and sterilization of medical devices

In Russia, all medical institutions are obliged to work at strict standards, among which an important place is the proper disinfection and sterilization of medical devices.

Why adhere to the

Disinfection and sterilization of medical devices

standard Today, many people, even people far from medicine, know such term as nosocomial infection. It includes any disease that a patient receives or a patient due to his recourse to a medical institution or the staff of an organization in the performance of his or her 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 apparent that 7 to 14% of newborns are infected in maternity homes and children's departments. Of course, such a picture can be observed far from in all medical organizations and their prevalence depends on many factors, such as the type of institution, the nature of the care provided, the intensity of the mechanisms for transferring the VBI, its structure. Against this background, one of the main non-specific measures to prevent the occurrence and transmission of nosocomial infection is disinfection and sterilization of medical devices.

Normative documents

In their work, all health facilities are guided by the recommendations fixed in many normative documents. The basic document is SanPiN( disinfection and sterilization of medical products in it is highlighted in a separate section).The last edition was approved in 2010.The following normative acts also determine the work of medical institutions.

  1. FZ No. 52, in which measures of epidemiological safety of the population are declared.
  2. Order No. 408( for viral hepatitis) of 12.07.1984.
  3. Order No. 720( to combat VBI).
  4. Order of 03.09.1999( 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 tools. It is they who are guided by all medical institutions in their work.

OST sterilization and disinfection of medical devices

In addition, there are a large number of methodological guidelines( MU), disinfection and sterilization of medical products in which is considered in terms of the various disinfectants allowed for this purpose. Today, due to the fact that a lot of des.means, the corresponding methodical instructions are also an integral part of the documents on which the work of the health facility is built. To date, the standard of processing tools consists of three consecutive stages - disinfection, JI and sterilization of medical devices.


Disinfection is a complex of measures, as a result of which pathogenic microorganisms are destroyed on environmental objects. These include surfaces( walls, floors, windows, hard furniture, equipment surfaces), nursing items( underwear, dishes, sanitation equipment), as well as biological liquids, discharge of patients, etc.

In the identified foci of infectioncarry out activities called "focal disinfection".Its goal is to destroy pathogens directly in the identified outbreak. There are the following types of focal disinfection:

  • current - it is carried out in hospitals to prevent the spread of infection;
  • final - is conducted after the source of infection is isolated, that is, the sick person was hospitalized.

In addition, there is a preventive disinfection. Its activities are held constantly, regardless of the presence of an infectious focus. This includes washing hands, cleaning the surrounding surfaces with the help of products that have bactericidal additives.

Disinfection methods

SanPiN disinfection and sterilization of medical devices

Depending on the objectives, the following disinfection methods are used:

  • mechanical : it refers directly to the mechanical effect on the subject - wet cleaning, shaking out 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 if the temperature and exposure time are accurately observed;
  • chemical : the destruction of pathogenic microorganisms with the help of chemicals - immersion, wiping or irrigation of the object with chemical solution( is the most common and effective method);
  • biological - in this case an antagonist of the microorganism is used, which is required to be destroyed( most often used on specialized bacteriological stations);
  • combined - combines several methods of disinfection.

OST "Sterilization and disinfection of medical devices" 42-21-2-85 asserts that all objects and instruments with which the patient has contact must pass through the process of disinfection. In the health facility, a physical or chemical method of disinfection is used for this. After its completion, the products, depending on their purpose, are further processed, recycled or used again.

Pre-sterilization cleaning

Disinfection and sterilization of medical devices for reusable instruments to be sterilized also involves pre-sterilization cleaning, which follows the disinfection of the product. The purpose of this stage is the final mechanical removal of residues of fat and protein contaminants, as well as medicines.

The new SanPiN, disinfection and sterilization of medical devices in which it is considered in sufficient detail, provides for the following stages of the JI project.

  1. For 0.5 minutes, the product is rinsed under running water to remove residual disinfectant solution.
  2. In a cleaning solution for which only authorized 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 available cavities are filled with a solution. At a washing solution temperature of 50º, the exposure is 15 minutes.
  3. After the expiry of the time, each product is washed with the ruff or gauze swab for 0.5 minutes in the same solution.
  4. The products are rinsed under running water. The duration of rinsing depends on the means used( "Astra", "Lotus" - 10 minutes, "Progress" - 5, "Biolot" - 3).
  5. Rinse in distilled water for 30 seconds.
  6. Drying in ovens with hot air.

5 g CMC( Progress, Astra, Lotos, Biolot), 33% perhydrol 16 g, or 27.5% -17 g are used to prepare the washing solution. Also, 6%( 85%d) and 3%( 170 g) of hydrogen peroxide, drinking water - up to 1 liter.

SP disinfection and sterilization of medical devices

Modern means used for disinfection, allow to combine disinfection processes and JI.In this case, after the end of the exposure directly to des.solution is carried out rassevanie tools and then - all subsequent stages of the PCP.

Quality control

JV, disinfection and sterilization of medical products in which are painted literally step by step, pay much attention and quality control of each stage of processing. To do this, samples that control the absence of blood on the processed product, other protein compounds, as well as the quality of flushing of detergents are carried out. Control is subjected to one percent of the treated instruments.

The phenolphthalein test allows one to assess how thoroughly the detergents were removed from the products that were used in the pre-sterilization treatment. To put it on a tampon, apply a small amount of a ready 1% solution of phenolphthalein and then wipe those items that you want to check. In the event that pink staining appears, the quality of washing out of detergents is recognized as insufficient.

Disinfection and sterilization of medical devices require control at each stage, and another sample, which allows one to assess how well the first steps were carried out, is the azopyramic test. She assesses the presence or absence of blood and drug substances on them. To carry out it requires a solution of azopiram, which can be stored in the prepared form 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 sample immediately before it is carried out, the same amount of azopiram and 3% hydrogen peroxide are mixed and applied to a spot of blood for testing. The appearance of violet staining means that the reagent is a worker, you can start checking. To do this, the prepared reagent is wetted with a tampon and wipes the surfaces of the instrument and equipment. In products having hollow channels, several drops of the reagent are placed inward and after 1 minute the result is evaluated, paying special attention to the joints. In the event that a violet 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.

Disinfection, PSO and sterilization of medical devices

For a correct evaluation of the results of the azopyramic test, several points must be taken into account:

  • a positive sample is considered only if the staining appears within the first minute after application of the reagent;
  • working solution can only be used within the first two hours after preparation;
  • products must be room temperature( on a hot surface the sample will be uninformative);
  • , regardless of the results, the products on which the sample was made, washed with water and again subjected to pre-sterile cleaning.

In case of obtaining positive results after the sampling, the whole lot is re-processed until a negative result is obtained.

Sterilization of

Sterilization is the final step in the treatment of products that have contact with the wound surface, mucous membrane or blood, as well as injections. At the same time, all forms of microorganisms, both vegetative and spore, are completely destroyed. The carrying out of all manipulations is regulated in detail by such normative document of the Ministry of Health, as an order. Sterilization and disinfection of medical devices are carried out according to the specifics of the medical institution and their purpose. Keep sterilized products, depending on the packaging, can be from days to six months.

Methods of sterilization

Methods of disinfection and sterilization of medical devices slightly differ from each other. Sterilization is carried out by the following methods:

  • thermal - air, steam, glasperlene;
  • chemical - gas or in solutions of chemical substances;
  • plasma or ozone;
  • radiation.

In the conditions of medical institutions, they usually use steam, air or chemical methods. 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 chosen depending on the material from which the processed article is made.

MU disinfection and sterilization of medical devices

Air Method

In this way, medical instruments, parts of apparatuses and instruments made of metal, glass and silicone rubber are sterilized. Before the sterilization cycle, the products must be thoroughly dried.

The maximum deviation from the temperature regime with this method of sterilization should not exceed 3 ° C.






200 °

30 minutes

Mercury thermometer

180 °

60 minutes

Hydroquinone, thiourea, tartaric acid

160 °

150 minutes


Steam method

The steam method is by far the most widely used,which is associated with a short cycle, the possibility of its use for sterilization of products made of non-resistant materials( underwear, suture and dressings, rubber, plastic, latex).Sterility with this method is achieved through the use of steam fed under excess pressure. This occurs in a steam sterilizer or in an autoclave.






132 °

20 minutes

IS-132, urea, nicotinamide


120 °

45 minutes

IS-120, benzoic acid


134 °

5 minutes



110 °

180 minutes

Antipyrine, resorcin

Deviations in pressure conditions are allowed up to 2 kg / m², and temperature conditions - 1-2 °.

Glasperlene sterilization

The technical support of medical institutions has improved significantly in recent years and this is noted in the latest joint venture( disinfection and sterilization of medical devices).A new method of sterilization, which has become widely used in health facilities, is glasperlene sterilization. It consists in immersing the instrument in a medium heated to 190 - 330 ° glass granules. The process of sterilization takes minutes, and after the tools is ready for use. The downside of this method is that it can only protect small tools, so it is used mainly in dental offices.

Mode of disinfection and sterilization of medical devices

Disinfection, pre-sterilization cleaning, sterilization of medical devices are the most important elements in the work of modern health facilities. The health of both patients and medical personnel will depend on how thoroughly all the measures are implemented, which are fixed in the normative acts approved by the Ministry of Health of the Russian Federation.