British Standards Institution

Source:: ISO
Committee:: CH/194 - Biological evaluation of medical devices
Categories:: Medical devices. Biological evaluation
Comment period start date:: 04/04/2025
Comment period end date:: 28/05/2025
Number of comments:: 0

Comment by:

28th May

Scope

This document specifies strategies for risk estimation and selection of biological harms identification tests with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:— genotoxicity;— carcinogenicity;— reproductive 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.NOTE Guidance on selection of relevant endpoints is provided in ISO 10993‑1.

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Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

29/01/2025

3. Public Comments

Public Comments start date:

04/04/2025

Public Comments end date:

28/05/2025

Learn more about the standards development process

Standards Development

BS EN ISO 10993-3 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

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