British Standards Institution

Source:: ISO
Committee:: CH/194 - Biological evaluation of medical devices
Categories:: Information management | Standardization. General rules

Scope

This document establishes best practice recommendations for:

— processing extracts for instrumental analysis;

— recognizing and addressing compromised extracts.

This document can be used in conjunction with ISO 10993-18.

Purpose

ISO 10993-18:2020, specifies a framework for the discovery, identification, and quantification of extractable and/or leachable constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents. ISO 10993-18: 2020 reflects and establishes those practical, achievable, and science-based best practices for leachables and extractables identification and quantification for which a consensus in the community of practice could be achieved. This document was written to augment ISO 10993-18:2020.

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

Standard timeline

1. Proposal

Proposal start date:

03/04/2025

Proposal end date:

25/05/2025

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

ISO/NP TS 25364-4 - Analytical chemistry matters associated with ISO 10993-18 — Part 4: Critical aspects of extract viability in extractables and leachables testing using non-targeted analysis (NTA)

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