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  • BSI
    19/30376763 DC BS EN ISO 10993-12. Biological evaluation of medical devices - Part 12. Sample preparation and reference materials
    Edition: 2019
    $44.66
    / user per year

Description of 19/30376763 DC 2019

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



Standard Number19/30376763 DC
TitleBS EN ISO 10993-12. Biological evaluation of medical devices - Part 12. Sample preparation and reference materials
StatusDefinitive
Publication Date2019-05-13
Identical National Standard OfISO/DIS 10993-12
DescriptorsSelection, Biological analysis and testing, Extraction, Specimen preparation, Control samples, Medical equipment, Extraction methods of analysis, Test specimens
ICS11.100.20 Biological evaluation of medical devices
CommitteeCH/194
PublisherBSI
Pages35

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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