ISO/TC 212
Clinical laboratory testing and in vitro diagnostic test systems
About
-
Secretariat: ANSI
Secretary: -
Chairperson (until end 2024):Dr Jack J. Zakowski
-
ISO Technical Programme Manager :ISO Editorial Programme Manager :
- 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 the ISO Committee on Reference Materials (REMCO);
- conformity assessment guidelines dealt with by the ISO Committee on Conformity assessment (CASCO).
Quick links
-
Drafts and new work items
-
TC Business plans for public review
-
on ISOTC and Public information folder
-
IT Tools that help support the standards development process
This committee contributes with 2 standards to the following Sustainable Development Goals:
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
Wayne, PA 19087-1898
United States
Tel: +1 610 688 01 00
Fax: +1 610 688 07 00
Web: http://www.clsi.org