About
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Secretariat: ANSI
Committee Manager: -
Chairperson (until end 2025):Mr Scott A. Colburn
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ISO Technical Programme Manager [TPM]:ISO Editorial Manager [EM]:
- Creation date: 1994
Scope
Standardization of requirements and guidance in the field of quality management and corresponding general aspects, for products with a health purpose, including connectors for liquid and gases.
Excluded:
- generic quality management standards dealt with by ISO / TC 176;
- quality management standards for pharmaceutical products and healthcare services;
Note: Products with a health purpose include products for use in relation to health, including medical devices, adjacent products [or could also say accessories] and those with a risk profile similar to medical devices.
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This committee contributes with 10 standards to the following Sustainable Development Goals:
Liaison Committees to ISO/TC 210
The committees below can access the documents of ISO/TC 210:
Reference | Title | ISO/IEC |
---|---|---|
IEC/SC 62A | Common aspects of medical equipment, software, and systems | IEC |
IEC/SC 62D | Particular medical equipment, software, and systems | IEC |
IEC/TC 56 | Dependability | IEC |
IEC/TC 62 | Medical equipment, software, and systems | IEC |
ISO/IEC JTC 1/SC 7 | Software and systems engineering | ISO/IEC |
ISO/IEC JTC 1/SC 42 | Artificial intelligence | ISO/IEC |
ISO/TC 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | ISO |
ISO/TC 84 | Devices for administration of medicinal products and catheters | ISO |
ISO/TC 106 | Dentistry | ISO |
ISO/TC 121 | Anaesthetic and respiratory equipment | ISO |
ISO/TC 150 | Implants for surgery | ISO |
ISO/TC 157 | Non-systemic contraceptives and STI barrier prophylactics | ISO |
ISO/TC 168 | Prosthetics and orthotics | ISO |
ISO/TC 170 | Surgical instruments | ISO |
ISO/TC 172/SC 5 | Microscopes and endoscopes | ISO |
ISO/TC 172/SC 7 | Ophthalmic optics and instruments | ISO |
ISO/TC 173 | Assistive products | ISO |
ISO/TC 173/SC 2 | Classification and terminology | ISO |
ISO/TC 176 | Quality management and quality assurance | ISO |
ISO/TC 176/SC 2 | Quality systems | ISO |
ISO/TC 194 | Biological and clinical evaluation of medical devices | ISO |
ISO/TC 198 | Sterilization of health care products | ISO |
ISO/TC 209 | Cleanrooms and associated controlled environments | ISO |
ISO/TC 212 | Medical laboratories and in vitro diagnostic systems | ISO |
ISO/TC 262 | Risk management | ISO |
ISO/TC 289 | Brand evaluation | ISO |
ISO/TC 304 | Healthcare organization management | ISO |
ISO/TC 314 | Ageing societies | ISO |
ISO/TC 338 | Menstrual products | ISO |
Liaison Committees from ISO/TC 210
ISO/TC 210 can access the documents of the committees below:
Reference | Title | ISO/IEC |
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ISO/CASCO | Committee on conformity assessment | ISO |
ISO/IEC JTC 1/SC 7 | Software and systems engineering | ISO/IEC |
ISO/IEC JTC 1/SC 42 | Artificial intelligence | ISO/IEC |
ISO/TC 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | ISO |
ISO/TC 84 | Devices for administration of medicinal products and catheters | ISO |
ISO/TC 106 | Dentistry | ISO |
ISO/TC 121 | Anaesthetic and respiratory equipment | ISO |
ISO/TC 145/SC 3 | Graphical symbols for use on equipment | ISO |
ISO/TC 150 | Implants for surgery | ISO |
ISO/TC 150/SC 2 | Cardiovascular implants and extracorporeal systems | ISO |
ISO/TC 150/SC 6 | Active implants | ISO |
ISO/TC 157 | Non-systemic contraceptives and STI barrier prophylactics | ISO |
ISO/TC 168 | Prosthetics and orthotics | ISO |
ISO/TC 170 | Surgical instruments | ISO |
ISO/TC 172/SC 7 | Ophthalmic optics and instruments | ISO |
ISO/TC 173 | Assistive products | ISO |
ISO/TC 173/SC 2 | Classification and terminology | ISO |
ISO/TC 176 | Quality management and quality assurance | ISO |
ISO/TC 176/SC 1 | Concepts and terminology | ISO |
ISO/TC 176/SC 2 | Quality systems | ISO |
ISO/TC 194 | Biological and clinical evaluation of medical devices | ISO |
ISO/TC 198 | Sterilization of health care products | ISO |
ISO/TC 209 | Cleanrooms and associated controlled environments | ISO |
ISO/TC 212 | Medical laboratories and in vitro diagnostic systems | ISO |
ISO/TC 215 | Health informatics | ISO |
ISO/TC 262 | Risk management | ISO |
ISO/TC 289 | Brand evaluation | ISO |
ISO/TC 304 | Healthcare organization management | ISO |
Organizations in liaison (Category A and B)
Acronym | Title | Category |
---|---|---|
AHWP | Asian Harmonization Working Party | A |
DITTA | Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association | A |
EUROM | European Federation of Precision Mechanical and Optical Industries | A |
IACRC | Inter-American Coalition for Regulatory Convergence | A |
IMDRF | International Medical Device Regulators Forum | A |
MedTech Europe | Alliance of European medical technology industry associations | A |
WFSA | World Federation of Societies of Anaesthesiologists | A |
WHO | World Health Organization | A |
Organizations in liaison (Category C)
C liaisons participate at the level of a Working Group
Acronym | Title | Category |
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GEDSA | The Global Enteral Device Supplier Association | C |
ISO/TC 210 - Secretariat
ANSI [United States]
Association for the Advancement of Medical Instrumentation
901 N. Glebe Road, Suite 300
Arlington 22203 VA
United States
Arlington 22203 VA
United States
Tel: +1 703 525 48 90
Fax: +1 703 276 07 93