GOST R 51609-2000 MEDICAL PRODUCTS. CLASSIFICATION IN ACCORDANCE WITH POTENTIAL RISK OF USING
Prepared and introduced by the Technical Committee No 11 “Medical instruments and apparatus”, the Committee on New Medical Equipment by the Ministry of Health of the Russian Federation, Private Company VNIIMP-VITA.
4. General requirements
4.1. For medical purposes all medical products (MP) are classified in accordance with degree of potential risk of using into four classes. Classes are designated as 1, 2a, 2b and 3. Degree of potential risk of using MP increases respectively listing of classes. Each MP belongs only to one class (see Supplement B):
Class 1 – MP with low degree of risk (some noninvasive electrodes, a number of surgical devices, some types of medical devices and so on);
Class 2а - MP with average degree of risk (diagnostic ultrasonic equipment, some dressing, some blood reagents, apparatus for physical therapy and so on);
Class 2b - MP with heightened degree of risk (apparatus for anaesthesia, apparatus for administration and so on);
Class 3 - MP with high degree of risk (implanted pacemaker, artificial heart valves, apparatus for hemodialysis and so on).
Sets of reagents may be referred to classes 2а, 2b or 3 depending on potential risk of results of their using.
4.2. Their functional purpose and conditions of using shall be taken into account when classifying MP.
4.2.1. MP classification criteria
When classifying MP the present Standard takes into account the following criteria:
- period of using MP;
- MP invasiveness;
- contact and relation with human body;
- mode of MP administration in body (through anatomic cavities or surgically);
- application to vital organs (heart, central circulatory system, central nervous system);
- using of energy sources.
4.3. Classifying Procedure
4.3.1. When filing an application and documents for MP registration the applicant shall specify MP class (see GOST R 15.013).
4.3.2. Class in accordance with potential risk of using for newly developed MP shall be specified in draft technical specification (see GOST R 15.013).
4.3.3. MP class shall be set by the Ministry of Health of the Russian Federation based on examination results provided by the applicant taking into account methods of medical use.
4.3.4. In case of disagreement with examination results the applicant is entitled to outline his/her proposals and provide to the Ministry of Health of the Russian Federation with materials necessary for supplementary examination on classification of the MP applied for in the appropriate manner.
4.3.5. Final decision on MP class shall be taken by the Ministry of Health of the Russian Federation.
4.4. The applicant shall have the right to reclassify MP unless and till it has been two years after MP registration or ahead of time if there are proper grounds. Reclassifying procedure is identical to classifying one.
4.5. MP, which have been registered by the Ministry of Health of the Russian Federation before putting the present Standard into effect, shall be classified upon reregistration at the end of effective period of the relevant registration certificate or before this period at the initiative of the applicant.
4. General requirements
4.1. For medical purposes all medical products (MP) are classified in accordance with degree of potential risk of using into four classes. Classes are designated as 1, 2a, 2b and 3. Degree of potential risk of using MP increases respectively listing of classes. Each MP belongs only to one class (see Supplement B):
Class 1 – MP with low degree of risk (some noninvasive electrodes, a number of surgical devices, some types of medical devices and so on);
Class 2а - MP with average degree of risk (diagnostic ultrasonic equipment, some dressing, some blood reagents, apparatus for physical therapy and so on);
Class 2b - MP with heightened degree of risk (apparatus for anaesthesia, apparatus for administration and so on);
Class 3 - MP with high degree of risk (implanted pacemaker, artificial heart valves, apparatus for hemodialysis and so on).
Sets of reagents may be referred to classes 2а, 2b or 3 depending on potential risk of results of their using.
4.2. Their functional purpose and conditions of using shall be taken into account when classifying MP.
4.2.1. MP classification criteria
When classifying MP the present Standard takes into account the following criteria:
- period of using MP;
- MP invasiveness;
- contact and relation with human body;
- mode of MP administration in body (through anatomic cavities or surgically);
- application to vital organs (heart, central circulatory system, central nervous system);
- using of energy sources.
4.3. Classifying Procedure
4.3.1. When filing an application and documents for MP registration the applicant shall specify MP class (see GOST R 15.013).
4.3.2. Class in accordance with potential risk of using for newly developed MP shall be specified in draft technical specification (see GOST R 15.013).
4.3.3. MP class shall be set by the Ministry of Health of the Russian Federation based on examination results provided by the applicant taking into account methods of medical use.
4.3.4. In case of disagreement with examination results the applicant is entitled to outline his/her proposals and provide to the Ministry of Health of the Russian Federation with materials necessary for supplementary examination on classification of the MP applied for in the appropriate manner.
4.3.5. Final decision on MP class shall be taken by the Ministry of Health of the Russian Federation.
4.4. The applicant shall have the right to reclassify MP unless and till it has been two years after MP registration or ahead of time if there are proper grounds. Reclassifying procedure is identical to classifying one.
4.5. MP, which have been registered by the Ministry of Health of the Russian Federation before putting the present Standard into effect, shall be classified upon reregistration at the end of effective period of the relevant registration certificate or before this period at the initiative of the applicant.
