British Standards Institution

Source:: ISO
Committee:: CH/194 - Biological evaluation of medical devices
Categories:: Medical devices. Biological evaluation
Comment period start date:: 28/03/2025
Comment period end date:: 21/05/2025
Number of comments:: 1

Comment by:

21st May

Scope

This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

23/01/2025

3. Public Comments

Public Comments start date:

28/03/2025

Public Comments end date:

21/05/2025

Learn more about the standards development process

Standards Development

BS EN ISO 10993-11 ISO 10993-11 Biological evaluation of medical devices. Part 11: Tests for systemic toxicity

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