2. Taking part
  3. Who develops standards
  4. Technical Committees
  5. ISO/TC 212

ISO/TC 212

Clinical laboratory testing and in vitro diagnostic test systems

 

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

35

published ISO standards *

under the direct responsibility of ISO/TC 212

14

ISO standards under development *

under the direct responsibility of ISO/TC 212

46

Participating members

20

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/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/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 283 Occupational health and safety management 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)

C liaisons participate at the level of a Working Group

Acronym Title Category
ABSA American Biological Safety Association C
A-PBA Asia-Pacific Biosafety Association C
BACAC Biosafety Association for Central Asia and the Caucasus C
EBSA European Biosafety Association C
IFBA International Federation of Biosafety Associations C
OIE World Organization for Animal Health (OIE) C
Date Month Location TC/SC Note
4-8 November 2019 Cuauhtémoc (Mexico) ISO/TC 212  

* Information definite but meeting not yet formally convened
** Provisional

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
Web:

Secretariat direct:
Mr David Sterry
Tel: +1 484 588 5942
  2. Taking part
  3. Who develops standards
  4. Technical Committees
  5. ISO/TC 212