BS EN ISO 10993-12:2012 PDF

Biological evaluation of medical devices - Sample preparation and reference materials

First page of standard BS EN ISO 10993-12:2012

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Title (English):

BS EN ISO 10993-12:2012

Biological evaluation of medical devices - Sample preparation and reference materials

Document status:: Withdrawn
Format:: Electronic (PDF)
Publication date:: October 31, 2012
ICS:: 11.100.20
Technical committee:: CEN
SKU:: BS EN ISO 10993-12:2012

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Abstract

1 Scope This part of ISO 10993 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 systems in accordance with one or more parts of ISO 10993. Specifically, this part of ISO 10993 addresses the following:

— test sample selection;

— selection of representative portions from a device;

— test sample preparation;

— experimental controls ;

— selection of, and requirements, for reference materials ;

— preparation of extracts .

This part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

Related standards

Mentioned in the description and other BS standards

— test sample selection;

— selection of representative portions from a device;

— test sample preparation;

— experimental controls ;

— selection of, and requirements, for reference materials ;

— preparation of extracts .

This part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

BS EN ISO 10993-12:2012 PDF

Abstract

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Abstract

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