ISO 10993-3:2026
Current
The latest, up-to-date edition.
Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity
Hardcopy , PDF
English, French
06-08-2026
This document specifies strategies for risk estimation and evaluation of biological harms with respect to:
- genotoxicity;
- carcinogenicity;
- reproductive toxicity; and
- developmental toxicity.
This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity has been established.
This document is not applicable to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products which are covered by regulations.
NOTE Guidance on selecting relevant biological effects for medical devices is covered in ISO10993-1.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
41
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
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