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  • BSI
    BS EN ISO 10993-12:2021 - TC Tracked Changes. Biological evaluation of medical devices - Sample preparation and reference materials
    Edition: 2021
    $620.36
    / user per year

Description of BS EN ISO 10993-12:2021 - TC 2021

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.



Standard NumberBS EN ISO 10993-12:2021 - TC
TitleTracked Changes. Biological evaluation of medical devices - Sample preparation and reference materials
StatusDefinitive
Publication Date2021-11-16
DescriptorsTest specimens, Control samples, Medical equipment, Extraction methods of analysis, Selection, Specimen preparation, Extraction, Biological analysis and testing
ICS11.100.20 Biological evaluation of medical devices
CommitteeCH/194
ISBN978 0 539 19918 5
PublisherBSI
Pages84

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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