British Standards Institution

Source:: ISO
Committee:: CH/194 - Biological evaluation of medical devices
Categories:: Medical devices. Biological evaluation
Number of comments:: 0

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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