British Standards Institution

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

Scope

This document was written to augment ISO 10993-18:2020. Specifically, this document addresses and
provides best practice recommendations for:
— Uncertainty in Leachables and Extractables Measurements;
— Derivation, Calculation and Application of the Analytical Evaluation Threshold (AET);
— Best Practices for Leachables and Extractables Identification;
— Best Practices for Leachables and Extractables Quantification;
— Requirements for Instrumentation and Human Resources.

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.

Comment on proposal

Required form fields are indicated by an asterisk (*) character.

How important do you think standardization is in this area? *

Do you agree that a standard on this subject is feasible?: *

Please give reasons for your selections above: *

Would you or your organization use the standard? *

Would you or your organization be prepared to participate in the development of the standard or to comment on the draft when it is available? *

Are you aware of any regulation, existing standards and other good practice information in this area in the UK (e.g. Industry codes of practice; company specifications, international or European Standards)? *

Would the development of a standard(s) in this area have a particular impact/relevance to SME, consumer, environmental or societal interests? *

Are you aware of any other organizations to which this proposal may be relevant? If so please provide details below. *

Additional comments on the scope or proposal:

Although BSI will not usually enter into correspondence regarding individual comments or suggestions we may wish to contact you to seek further clarification. Please indicate whether this will be acceptable: *

Discard

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

Standard timeline

1. Proposal

Proposal start date:

14/07/2024

Proposal end date:

05/09/2024

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 Discovery, Identification and Quantification of Medical Device Extractables and Leachables via Non-Target Analysis (NTA) — Analytical Chemistry Matters Associated with ISO 10993-18

Scope

Purpose

Comment on proposal

Discard changes?

Submit comment

Submit comment

Follow standard

Unfollow standard

Error