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

Show Complete Document History

Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:

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.




Want this as a site license?


Claudia's Notes:
This part of ISO 10993 is based on existing national and international specifications, regulations and standards wherever possible. ISO Technical Committee 194 periodically reviews the document and revises as necessary.

To find similar documents by classification:

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.


Customers who bought this document also bought:

Standard Practice for Performance Testing of Shipping Containers and Systems

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Standard Test Method for Seal Strength of Flexible Barrier Materials

Document Number

ISO 10993-12:2021

Revision Level




Publication Date

Jan. 25, 2021

Committee Number

ISO/TC 194