ISO - ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems

About

Secretariat: ANSI

Committee Manager:

Mr David Sterry
Chairperson (until end 2027):

Mr Jesus Rueda Rodriguez
ISO Technical Programme Manager [TPM]:

Ms Isabelle Vega

ISO Editorial Manager [EM]:

Ms Claudia Lueje
Creation date: 1994

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 ISO/TC 334 the Committee on Reference Materials (REMCO);
conformity assessment guidelines dealt with by the ISO Committee on Conformity assessment (CASCO).

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This committee contributes with 31 standards to the following Sustainable Development Goals:

Good Health and Well-being

Quality Education

Industry, Innovation and Infrastructure

Sustainable Cities and Communities

Responsible Consumption and Production

published ISO standards *

ISO standards under development *

Participating members

Observing members

* number includes updates

Structure
Liaisons

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 medical devices	ISO
ISO/TC 215	Health informatics	ISO
ISO/TC 276	Biotechnology	ISO
ISO/TC 283	Occupational health and safety management	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 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
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
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
IFBA	International Federation of Biosafety Associations	C
Instand-NGS4P	Integrated and standardized NGS workflows for Personalised therapy	C
OIE	World Organization for Animal Health (OIE)	C