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Standard [WITHDRAWN]

DIN EN ISO 10993-12:2012-10

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012

German title
Biologische Beurteilung von Medizinprodukten - Teil 12: Probenvorbereitung und Referenzmaterialien (ISO 10993-12:2012); Deutsche Fassung EN ISO 10993-12:2012
Publication date
2012-10
Original language
German
Pages
33

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Publication date
2012-10
Original language
German
Pages
33
DOI
https://dx.doi.org/10.31030/1860096

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Overview

This standard 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 series 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 standard is not applicable to materials or products containing live cells. This standard is directed at manufacturers of medical devices and test laboratories. The committee responsible for this standard is NA 027-02-12 AA "Biologische Beurteilung von Medizinprodukten" ("Biological evaluation of medical devices") at DIN.

Content
ICS
11.100.20
DOI
https://dx.doi.org/10.31030/1860096
Replacement amendments

This document replaces DIN EN ISO 10993-12:2009-08 .

This document has been replaced by:: DIN EN ISO 10993-12:2021-08 .

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