February 22, 2018
How to define necessary numbers of samples for biocompatibility trials?
The standard, that regulates this number in Russia is GOST 31214. And its actual version is GOST 31214-2016 (started from 01.10.2017). The Annex A of this standards contains the table, regulating the necessary number of samples. You can see this below:
| Name of medical devices and materials | Minimal necessary number of samples |
| 1. Implantable devices (except of devices for cardio surgery and ophthalmic) | 5 items |
| 2. Devices for cardio surgery: implantable stimulators of internal organs, pacemakers | 5 items |
| 3. Dental (stomatology) materials | According to GOST 31576 |
| 4. Ophthalmic devices:
- intraocular lenses - Scleroplastical material - Antiglaucomal drainages
- Contact lenses - Ocular protheses - glass lenses, glass frames - Gels for ophthalmic surgery
|
20 items 10 items According to agreement with declarant
15 items 5 items 5 items 50 ml |
| 5. Contraceptive devices:
- intrauterine devices - condoms - diaphragms, cervical caps |
5 items 10 items 10 items |
| 6. Devices for connection and agglutinations of tissues:
- bone cementums - glue composites - Materials for tissue plastic - Brackets for tissue staplers
|
4 packages 4 packages Gels - 25 ml, other devices - 5 items According to agreement with declarant |
| 7. Catheters, probes, bougies, drainages, shunts, ferrules | 10 items |
| 8. Probes, electrodes for diagnostic and therapeutic devices | 5 items
For sterile - 3 sets |
| 9. Surgical tools of different purpose | 5 items, Stomatological tools - According to GOST 31576 |
| 10. Containers and reservoirs for blood, its components and blood substitute storage | 10 items |
| 11. blood gas exchange deviceы, hemodialyzers with blood lines | 5 items |
| 12. Sorbents (hemo- and immunosorbents, lymph sorbents) | 5 devices |
| 13. Tares, packages for medicines:
- stoppers - containers |
30 items with summary volume 250 ml, but no less than 5 devices |
| 14. Devices with short contact with blood and lymph:
- Exfusion, transfusion and infusion devices - Blood line - sterile injectors
|
10 items 10 items Number of injectors with summary volume 200 ml |
| 15. Surgical sutures | 5 items |
| 16. Bandaging, burns healing, drainaging, absorbing materials | According to agreement with declarant |
| 17. Nappies, swaddling bands, sanitary pads, tampons | 3 items, 2 packages (of tampons) |
| 18. Medical gloves | Sterile - 10 pairs,
non sterile - 5 pairs |
| 19. Neonatal incubators | According to agreement with declarant |
| 20. Anesthesia-respiratory apparatus | Modules with a direct or indirect contact with organism - According to agreement with declarant |
| 21. Gum syringes | 5 items |
| 22. Esmarch irrigators, hot-water bottles, tourniquets | 3 items |
| 23. Orthopedic devices | 3 items |
| 24. Inhalers | 3 items |
| 25. Devices (materials) for fixing, immobilization of tissues and organs (plasters, films, bandaging materials, elastic bandages, gypseous bandages) | Non sterile - 3 items,
sterile - 5 items |
| 26. Devices for external prosthesis:
- corsets, prosthesis cases, prostheses etc. |
According to agreement with declarant |
| 27. Bedclothes, medical clothes | Sterile - 5 sets,
non-sterile - 3 sets |
| 28. Urinals and ostomy pouching systems | 3 items |
| 29. Litters, blankets | 100 cm2 of device’s material |
| 30. Hearing aids | 3 items |
| 31. Liquids, gels, contact pastes | 1 package (no less than 100 g) |
| 32. Massaging devices, applicators | According to agreement with declarant |
| 33. X-ray protective devices | 1 device |
We hope, that this information will help you during the routine of state registration of your device.
