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:
| 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 * |
* The convener can be reached through the secretariat (See contact information below)
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 administration | ISO |
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 administration | ISO |
| Acronym | Title | Liaison type |
|---|---|---|
| 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 |
| 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 |