About

Scope

Standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems. This includes, for example, quality management, pre- and post-analytical 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 the ISO Committee on Reference Materials (REMCO);
  • conformity assessment guidelines dealt with by the ISO Committee on Conformity assessment (CASCO).

Quick links

27

published ISO standards *

under the direct responsibility of ISO/TC 212

21

ISO standards under development *

under the direct responsibility of ISO/TC 212

40

Participating members

23

Observing members

* number includes updates

Reference Title Type
ISO/TC 212/WG 1 Quality and competence in the medical laboratory Working group
ISO/TC 212/WG 2 Reference systems Working group
ISO/TC 212/WG 3 In vitro diagnostic products Working group
ISO/TC 212/WG 4 Microbiology and molecular diagnostics Working group
ISO/TC 212/WG 5 Laboratory biorisk management Working group
Liaison Committees to ISO/TC 212

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

Reference Title ISO/IEC
IEC/TC 66 Safety of measuring, control and laboratory equipment IEC
ISO/CASCO Committee on conformity assessment ISO
ISO/PC 302 Guidelines for auditing management systems ISO
ISO/REMCO Committee on reference materials ISO
ISO/TC 34 Food products ISO
ISO/TC 34/SC 9 Microbiology ISO
ISO/TC 34/SC 16 Horizontal methods for molecular biomarker analysis ISO
ISO/TC 48 Laboratory equipment ISO
ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use ISO
ISO/TC 150/SC 7 Tissue-engineered medical products ISO
ISO/TC 176 Quality management and quality assurance ISO
ISO/TC 210 Quality management and corresponding general aspects for medical devices ISO
ISO/TC 215 Health informatics ISO
ISO/TC 276 Biotechnology ISO
ISO/TC 304 Healthcare organization management ISO
Liaison Committees from ISO/TC 212

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

Reference Title ISO/IEC
ISO/CASCO Committee on conformity assessment ISO
ISO/PC 283 Occupational health and safety management systems ISO
ISO/REMCO Committee on reference materials ISO
ISO/TC 34 Food products ISO
ISO/TC 34/SC 9 Microbiology ISO
ISO/TC 34/SC 16 Horizontal methods for molecular biomarker analysis ISO
ISO/TC 48 Laboratory equipment ISO
ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use ISO
ISO/TC 150/SC 7 Tissue-engineered medical products ISO
ISO/TC 176 Quality management and quality assurance ISO
ISO/TC 194 Biological and clinical evaluation of medical devices ISO
ISO/TC 207/SC 1 Environmental management systems ISO
ISO/TC 210 Quality management and corresponding general aspects for medical devices ISO
ISO/TC 215 Health informatics ISO
ISO/TC 262 Risk management ISO
ISO/TC 276 Biotechnology ISO
ISO/TC 304 Healthcare organization management ISO
Organizations in liaison (Category A and B)
Acronym Title Category
AHWP Asian Harmonization Working Party A
ASLM African Society for Laboratory Medicine A
BBMRI-ERIC Biobanking and BioMolecular resources Research Infrastructure A
BIPM International Bureau of Weights and Measures A
EC4 European Communities Confederation of Clinical Chemistry A
EC - European Commission European Commission A
EFLM European Federation of Clinical Chemistry and Laboratory Medicine A
EUROM European Federation of Precision Mechanical and Optical Industries A
ICSH International Council for Standardization in Haematology A
IFBLS International Federation of Biomedical Laboratory Science A
IFCC International Federation of Clinical Chemistry and Laboratory Medicine A
ILAC International Laboratory Accreditation Cooperation A
IUPAC International Union of Pure and Applied Chemistry A
MedTech Europe Alliance of European medical technology industry associations A
OECD Organisation for Economic Co-operation and Development, OECD A
WASPaLM World Association of Societies of Pathology and Laboratory Medicine A
WHO World Health Organization A

Organizations in liaison (Category C and D)

C & D liaisons participate at the level of a Working Group

Acronym Title Category
ABSA American Biological Safety Association D
A-PBA Asia-Pacific Biosafety Association D
BACAC Biosafety Association for Central Asia and the Caucasus D
EBSA European Biosafety Association D
IFBA International Federation of Biosafety Associations D
OIE World Organization for Animal Health (OIE) D

ISO/TC 212 - Secretariat

ANSI United States
Clinical and Laboratory Standards Institute
950 West Valley Road, Suite 2500
Wayne, PA 19087-1898
United States

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

Secretariat direct:
Mr David Sterry
Tel: +1 484 588 5942