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PS 3358-2026
Active
Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
Committee:
Medical Devices and Supplies
Sector:
Health and Personal Care
Available Standards
Original Standard
إنجليزي (English)
70
Page
2026
International Classification for Standards (ICS)
| Code | Classification |
|---|---|
| 11.060.10 | Dental materials |
| 11.100.99 | Other standards related to laboratory medicine |
Adopted Standards
| Standards / Amendment / Corrigendum | |
|---|---|
| 1 | ISO 7405:2025 |
Scope
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.