Technical regulation – 2018

These publication are about standards, how and when apply them – main topic, of course, standards for medical devices but some articles are about beginning (good to know information about main points of technical regulation in Russian Federation):

1 – Part 1. Introduction;

2 – Part 2. Samples quantity for biocompatibility studies;

3 – Part 3. Not only GOST R as national standard;

4 – Part 4. Samples quantity for biocompatibility studies – stomatology (dental) materials;

5 – Part 5. Medical device labeling;

6 – Part 6. Medical device labeling (active devices);

7 – Part 7. Labeling of batteries;

8 – Part 8. Classification in GOST R 50444-92;

9 – Part 9. Climatic zone classification for medical devices;

10 – Part 10. About electrical safety classification for medical devices.