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Norm

ISO 10993-12:2021

Issue date: 2021 01 20

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testin...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 21 Pages
Language:
English

This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.

Specifically, this document addresses the following:

— test sample selection;

— selection of representative portions from a medical device;

— test sample preparation;

— experimental controls;

— selection of, and requirements for, reference materials;

— preparation of extracts.

This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.

Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.

ISO 10993-12:2021
2021 01 20
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Norm
ISO 10993-12:2012
2012 06 29
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Norm
ISO 10993-12:2007
2007 10 31
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corr...
Norm
ISO 10993-12:2002
2002 12 11
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corr...
Norm
ISO 10993-12:1996
1996 09 05
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Norm
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