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Article 38. Medical devices
1. Medical products are any tools, devices, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the condition of the human body, conducting medical research, restored ia, substitution, changes in the anatomical structure or physiological functions of the body, prevention or termination of pregnancy, the functional purpose of which is not realized through pharmacological, immunological, genetic or metabolic effects on the human body. Medical devices may be considered interchangeable if they are comparable in terms of functionality, quality and technical characteristics and are able to replace each other.
2. Medical devices are divided into classes depending on the potential risk of their use and types in accordance with the nomenclature classification of medical devices. The nomenclature classification of medical devices is approved by the authorized federal executive body.
3. The circulation of medical devices includes technical tests, toxicological studies, clinical trials, examination of the quality, effectiveness and safety of medical devices, their state registration, production, manufacture, import into the territory of the Russian Federation, export from the territory of the Russian Federation, confirmation of compliance, state control, storage, transportation, implementation, installation, commissioning, use, operation, including maintenance, provided for by the norm explicit, technical and (or) operational documentation of the manufacturer, as well as repair, disposal or destruction.
4. On the territory of the Russian Federation, the circulation of medical devices registered in the manner established by the Government of the Russian Federation authorized by the federal executive authority is permitted.
5. Medical devices that are manufactured according to individual orders of patients, which are subject to special requirements for the appointment of medical workers and which are intended exclusively for personal use by a particular patient, are not subject to state registration.
6. The procedure for importing medical devices into the territory of the Russian Federation for state registration is established by the authorized federal executive body.
The import into the territory of the Russian Federation and the export from the territory of the Russian Federation of medical devices within the framework of doping control is carried out in accordance with the procedure established by the Government of the Russian Federation.
8. In order to state registration of medical devices in accordance with the procedure established by the authorized federal executive body, conformity assessment is carried out in the form of technical tests, toxicological studies, clinical trials and examination of the quality, effectiveness and safety of medical devices, as well as tests to approve the type of measuring instruments (in relation to medical devices related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, per ry of which is approved by the authorized federal executive body).
9. For state registration of medical devices and examination of the quality of efficiency and safety of medical devices, a state duty is levied in accordance with the legislation of the Russian Federation on taxes and fees.
10. In accordance with the procedure established by the Government of the Russian Federation, the federal executive body authorized by it maintains the state register of medical devices and organizations manufacturing and manufacturing medical devices, and places it on its official website on the Internet.
11. The following information shall be entered in the state register of medical devices and organizations engaged in the production and manufacture of medical devices:
1) the name of the medical device;
2) the date of state registration of the medical device and its registration number, the validity of the registration certificate;
3) the purpose of the medical device established by the manufacturer;
4) type of medical device;
5) the class of potential risk of using a medical device;
6) the code of the All-Russian classifier of products for a medical device;
7) the name and location of the organization - the applicant of the medical device;
8) the name and location of the organization - the manufacturer of the medical device or the organization - the manufacturer of the medical device;
9) the address of the place of manufacture or manufacture of the medical device;
10) information about interchangeable medical devices.
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Article 38. Medical devices
- Article 96. Monitoring the safety of medical devices
1. Medical devices in circulation in the territory of the Russian Federation are subject to safety monitoring in order to identify and prevent side effects not specified in the instructions for use or the operation manual of the medical device, undesirable reactions during its use, the characteristics of the interaction of medical devices with each other, facts and circumstances
- Article 95. State control over the circulation of medical devices
1. The circulation of medical devices, which is carried out on the territory of the Russian Federation, is subject to state control. 2. State control over the circulation of medical devices is carried out by the federal executive body authorized by the Government of the Russian Federation. 3. State control over the circulation of medical devices includes control over
- ANNEX 1. Sterilization of medical devices
All medical devices (hereinafter referred to as “the products”) in contact with the wound surface, in contact with blood or injection drugs, as well as certain types of products that come into contact with the mucous membrane during operation and may cause damage to it, are subjected to pre-sterilization cleaning and sterilization. Pre-sterilization cleaning Pre-sterilization
- ANNEX 1. Methods of quality control of disinfection of medical devices
The quality of disinfection is judged by the absence of staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli bacteria on medical devices after it. Control is subject to 1% of simultaneously processed products of the same name (but not less than 3-5 units). The quality control of disinfection is carried out by the method of flushing. Swabs are taken from product surfaces
- Industry standard. Sterilization and disinfection of medical devices (Extracts)
OST 42-21-2-85 was put into effect by Order of 10.06.85 No. 770 (extracts) Methods, means and modes Non-compliance with the standard is prosecuted 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
- Quality control of pre-sterilization cleaning of medical devices using azopyram reagent
(Approved by the General Directorate of Quarantine Infections of the Ministry of Health of the USSR dated 08.05.88 No. 28-6 / 13) (Methodical instructions) General part The methodological guidelines regulate the quality control of pre-sterilization cleaning of various medical devices using the new azopyram reagent. The test with azopyram in sensitivity is not inferior to benzidine and 10 times higher
- Article 37. Procedures for the provision of medical care and standards of medical care
1. Medical care is organized and provided in accordance with the procedures for the provision of medical care, mandatory for execution in the territory of the Russian Federation by all medical organizations, as well as on the basis of medical care standards. 2. The procedures for the provision of medical care and the standards of medical care are approved by the authorized federal executive body.
- Article 20. Informed voluntary consent to medical intervention and to refusal of medical intervention
1. A necessary prerequisite for medical intervention is the provision of informed voluntary consent of a citizen or his legal representative for medical intervention on the basis of the complete information provided by the medical officer in an accessible form about the goals, methods of providing medical care, the risk associated with them, possible options for medical intervention,
- Guidelines for the use of corrosion inhibitors in the process of pre-sterilization cleaning of medical devices from metal
(Approved by the General Directorate of Quarantine Infections of the Ministry of Health of the USSR dated April 30, 86 No. 28-6 / 16) General Provisions The guidelines are an addition to the “Guidelines for the pre-sterilization cleaning of medical devices” approved by the Ministry of Health of the USSR on 08.06.82. No. 28-6 / 13. Guidelines are intended for employees of medical institutions,
- Article 79. Obligations of medical organizations
1. A medical organization must: 1) provide emergency medical assistance to citizens; 2) carry out medical activities in accordance with legislative and other regulatory legal acts of the Russian Federation, including the procedures for the provision of medical care and standards of medical care; 3) inform citizens about the possibility of receiving medical care in