DPS
Drejtoria e Përgjithshme e Standardizimit
Tel/Cel: +355 4 222 62 55
E-mail: info@dps.gov.al
Adresa: Rr.: "Reshit Collaku", (pranë ILDKPKI, kati VI), Kutia Postare 98, Tiranë - Shqipëri
Main menu

ISO 10993-12:2012

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
29 qer 2012
95.99 Withdrawal of Standard   20 jan 2021

General information

95.99     20 jan 2021

ISO

ISO/TC 194

International Standard

11.100.20  

anglisht   frëngjisht  

Buying

Shfuqizuar

Language in which you want to receive the document.

Scope

ISO 10993-12:2012 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, ISO 10993-12:2012 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.

ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10993-12:2007

NOW

WITHDRAWN
ISO 10993-12:2012
95.99 Withdrawal of Standard
20 jan 2021

REVISED BY

PUBLISHED
ISO 10993-12:2021