Standard Svensk standard · SS-EN ISO 10993-12:2021

Biologisk värdering av medicintekniska produkter - Del 12: Provberedning och referensmaterial (ISO 10993-12:2021)

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Standard Svensk standard · SS-EN ISO 10993-12:2021

Biologisk värdering av medicintekniska produkter - Del 12: Provberedning och referensmaterial (ISO 10993-12:2021)
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Omfattning
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.

Ämnesområden

Biologisk värdering av medicintekniska produkter (11.100.20)


Köp denna standard

Standard Svensk standard · SS-EN ISO 10993-12:2021

Biologisk värdering av medicintekniska produkter - Del 12: Provberedning och referensmaterial (ISO 10993-12:2021)
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Pris: 995 SEK
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Pris: 995 SEK
standard ikon

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Pris: 1 592 SEK
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Produktinformation

Språk: Engelska

Framtagen av: Std Vård

Internationell titel: Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

Artikelnummer: STD-80029875

Utgåva: 6

Fastställd: 2021-06-22

Antal sidor: 36

Ersätter: SS-EN ISO 10993-12:2012