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.