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

Sustainable Development Goals

This committee contributes with 37 standards to the following Sustainable Development Goals:

3
Good Health and Well-being
4
Quality Education
8
Decent Work and Economic Growth
9
Industry, Innovation and Infrastructure
11
Sustainable Cities and Communities
12
Responsible Consumption and Production
13
Climate Action
53

Published ISO standards *

16

ISO standards under development *

43
Participating members
31
Observing members

* number includes updates

Reference Title Type
ISO/TC 212/JWG 6   Joint ISO/TC 212 - ISO/TC 276 WG: Quality practice for detection of SARS-CoV-2 Working group
ISO/TC 212/STTF   Spanish translation task force Working group
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/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 products with a health purpose including medical devices ISO
ISO/TC 215 Health informatics ISO
ISO/TC 276 Biotechnology ISO
ISO/TC 283 Occupational health and safety management ISO
ISO/PC 302 Guidelines for auditing management systems ISO
ISO/TC 304 Healthcare organization management ISO
ISO/TC 334 Reference materials ISO
ISO/TC 336 Laboratory design 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/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 products with a health purpose including medical devices ISO
ISO/TC 215 Health informatics ISO
ISO/TC 229 Nanotechnologies ISO
ISO/TC 262 Risk management ISO
ISO/TC 276 Biotechnology ISO
ISO/TC 283 Occupational health and safety management ISO
ISO/PC 302 Guidelines for auditing management systems ISO
ISO/TC 304 Healthcare organization management ISO
ISO/TC 334 Reference materials 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
CLSI Clinical and Laboratory Standards Institute, Inc A
EC - European Commission European Commission A
EC4 European Communities Confederation of Clinical Chemistry 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
A-PBA Asia-Pacific Biosafety Association C
ABSA American Biological Safety Association C
BACAC Biosafety Association for Central Asia and the Caucasus C
EBSA European Biosafety Association C
EMPAIA EMPAIA International e. V. C
IARC International Agency for Research on Cancer C
IFBA International Federation of Biosafety Associations C
Instand-NGS4P Integrated and standardized NGS workflows for Personalised therapy C
WOAH World Organization for Animal Health (WOAH) C

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
Web:

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