Standard

SN EN ISO 10993-12:1997

Jan 1997 Withdrawn

Note: Latest version: SN EN ISO 10993-12:2021

Existing or new amendments and versions must be purchased separately.

Language German

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Abstract

The document specifies requirements and gives guidance on procedures to be followed in the preparation of samples of medical devices for testing in biological systems in accordance with one or more other parts of ISO 10993. These include; a) test material selection; b) selection of representative portions from a device; c) test sample preparation; d) the selection of reference materials to demonstrate the suitability of the test systems and/or to enable relative comparison of the biological activity of the test sample; and e) preparation of extract.

Products specifications

Standard from INB
Published: January 1 1997
Withdrawn: April 1 2005
Effective: May 1 1997
Document type: EN
Pages
ISBN:

ICS: 11.040.01
ICS: 11.060.01
ICS: 11.120.01
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 129

Product Relations

Replaced by: SN EN ISO 10993-12:2005
Adopted from: ISO 10993-12:1996, IDT
Adopted from: EN ISO 10993-12 , IDT

SN EN ISO 10993-12:1997

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SN EN ISO 10993-12:2021

SN EN ISO 10993-12:2012

SN EN ISO 10993-12:2009

SN EN ISO 10993-12:2008

SN EN ISO 10993-12:2005