Sobre
-
Secretaría: ANSI (United States)Responsable de comité:
-
Presidente/a (hasta el final 2027):Mr Jesus Rueda Rodriguez
-
Responsable de programa técnico de ISO [TPM]:Responsable editorial de ISO [EM]:
- Fecha de creación: 1994
Alcance
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).
Enlaces rápidos
-
Programa de trabajo
Borradores y nuevos elementos de trabajo -
Área de trabajo
Documentos de trabajo (se requiere cuenta de usuario) -
Aplicaciones electrónicas de ISO
Herramientas de TI que apoyan el proceso de desarrollo de normas -
Material público
Consulte los documentos que pone a disposición este grupo - TC business plan for public review
Este comité contribuye con 51 normas a los siguientes Objetivos de Desarrollo Sostenible:
Grupos de trabajo conjuntos bajo la responsabilidad de otro comité
| Referencia | Título |
|---|---|
| ISO/TC 34/SC 9/JWG 1 | Joint ISO/TC 34/SC 9, ISO/TC 34/SC 16 and ISO/TC 212: Whole Genome Sequencing - Based Detection of Antimicrobial Resistance Determinants |
Comités de enlace a ISO/TC 212
Los comités que aparecen a continuación pueden acceder a los documentos de ISO/TC 212:
| Referencia | Título | ISO/IEC |
|---|---|---|
| IEC/SC 62D | Particular medical equipment, software, and systems | IEC |
| IEC/TC 62 | Medical equipment, software, and systems | 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 147/SC 4 | Microbiological methods | 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 276/SC 1 | Analytical methods | 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 |
Comités de enlace de ISO/TC 212
ISO/TC 212 pueden acceder a los documentos de los comités que aparecen a continuación:
| Referencia | Título | ISO/IEC |
|---|---|---|
| IEC/SC 62D | Particular medical equipment, software, and systems | 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 |
Organizaciones de enlace (categorías A y B)
| Sigla | Título | Categoría |
|---|---|---|
| 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 |
| GHWP | Global Harmonization Working Party | 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 |
Organizaciones de enlace (categoría C)
Los enlaces C participan a nivel de grupo de trabajo
| Sigla | Título | Categoría |
|---|---|---|
| A-PBA | Asia-Pacific Biosafety Association | C |
| ABSA | American Biological Safety Association | C |
| BACAC | Biosafety Association for Central Asia and the Caucasus | C |
| Bigpicture | Bigpicture | 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 |
| WOAH | World Organization for Animal Health (WOAH) | C |
| Fecha | Mes | Ubicación | TC/SC | Nota |
|---|---|---|---|---|
| 21-22 | October 2026 | Singapore (Singapore) | ISO/TC 212 |
* Información definitiva, pero la reunión aún no se ha convocado formalmente
** Provisional
ISO/TC 212 - Secretaría
ANSI (United States)
Clinical and Laboratory Standards Institute
5 Great Valley Parkway, Suite 219
Malvern 19355 PA
United States
Malvern 19355 PA
United States
Tel: +1 610 688 01 00
Fax: +1 610 688 07 00
Web: http://www.clsi.org