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.