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):
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.