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.