ISO 10993-12:2021

International Standard   Current Edition · Approved on 20 January 2021

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

ISO 10993-12:2021 Files

English 21 Pages
Current Edition
63.29 OMR

ISO 10993-12:2021 Scope

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.

Best Sellers

GSO 150-2:2013
 
Gulf Standard
Expiration dates for food products - Part 2 : Voluntary expiration dates
OS GSO 150-2:2013
GSO 150-2:2013 
Omani Standard
Expiration dates for food products - Part 2 : Voluntary expiration dates
OS GSO 2055-1:2015
GSO 2055-1:2015 
Omani Standard
HALAL FOOD - Part 1 : General Requirements
GSO 2055-1:2015
 
Gulf Technical Regulation
HALAL FOOD - Part 1 : General Requirements

Recently Published

ISO 37303:2025
 
International Standard
Compliance management systems — Guidance for competence management
ISO 37302:2025
 
International Standard
Compliance management systems — Guidance for the evaluation of effectiveness
ISO 21740:2025
 
International Standard
Space systems — Launch window estimation and collision avoidance
ISO 7899-3:2025
 
International Standard
Water quality — Enumeration of intestinal enterococci — Part 3: Most probable number method