EN ISO 10993-12:2021

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

Publication date:   Oct 14, 2021

General information

60.60 Standard published   Jun 16, 2021


CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100.20   Biological evaluation of medical devices



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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.

Related legislation

Legislation related to this standard


Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC


Life cycle


EN ISO 10993-12:2012


EN ISO 10993-12:2021
60.60 Standard published
Jun 16, 2021


EN ISO 10993-12:2021/prA1