About

Scope

Standardization and guidance in the field of medical laboratories and in vitro diagnostic systems. This includes, for example, quality management, pre- and postanalytical procedures, analytical performance, laboratory safety, reference systems and quality assurance.

Excluded:

  • generic quality management standards dealt with by ISO/TC 176;
  • quality management standards for medical devices dealt with by ISO/TC 210;
  • reference materials guidelines dealt with by ISO/TC 334 the Committee on Reference Materials (REMCO);
  • conformity assessment guidelines dealt with by the ISO Committee on Conformity assessment (CASCO).

Quick links

55

Published ISO standards *

16

ISO standards under development *

44
Participating members
30
Observing members

* number includes updates

Liaison Committees to ISO/TC 212

The committees below can access the documents of ISO/TC 212:

 

Liaison Committees from ISO/TC 212

ISO/TC 212 can access the documents of the committees below:

 

Organizations in liaison (Category A and B)

Organizations in liaison (Category C)

C liaisons participate at the level of a Working Group

ISO/TC 212 - Secretariat

ANSI (United States)

Clinical and Laboratory Standards Institute
5 Great Valley Parkway, Suite 219
Malvern 19355 PA
United States

Tel: +1 610 688 01 00
Fax: +1 610 688 07 00