About

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.

Quick links

Sustainable Development Goals

This committee contributes with 12 standards to the following Sustainable Development Goals:

3
Good Health and Well-being
4
Quality Education
9
Industry, Innovation and Infrastructure
10
Reduced Inequalities
12
Responsible Consumption and Production
16
Peace, Justice and Strong Institutions
32

Published ISO standards *

13

ISO standards under development *

41
Participating members
30
Observing members

* number includes updates

Reference Title Type
ISO/TC 210/AHG   Ad-hoc group for ISO 22740 Working group
ISO/TC 210/AHG 4   Assessment of ISO 13485 Working group
ISO/TC 210/AHG 5   Collaboration with IMDRF on guidance documents Working group
ISO/TC 210/ATTF   Arabic translation task force Working group
ISO/TC 210/CAG   Chair Advisory Group Working group
ISO/TC 210/JWG 1   Joint ISO/TC 210-IEC/SC 62A WG : Application of risk management to medical devices Working group
ISO/TC 210/JWG 2   Joint ISO/TC 210-IEC/SC 62A WG : Medical device software Working group
ISO/TC 210/JWG 3   Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability Working group
ISO/TC 210/JWG 4   Joint ISO/TC 210 - IEC/SC 62D WG: Small bore connectors Working group
ISO/TC 210/STTF   Spanish translation task force Working group
ISO/TC 210/TG 1   Review of Strategic Business Plan Working group
ISO/TC 210/WG 1   Application of quality systems to medical devices Working group
ISO/TC 210/WG 2   General aspects stemming from the application of quality principles to medical devices Working group
ISO/TC 210/WG 3   Symbols and nomenclature for medical devices Working group
ISO/TC 210/WG 5   Connectors for reservoir delivery systems Working group
ISO/TC 210/WG 6   Application of post market surveillance systems to medical devices Working group
ISO/TC 210/WG 7   Good engineering maintenance management Working group
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 150/SC 2 Cardiovascular implants and extracorporeal systems 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
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
DITTA Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association A
EUROM European Federation of Precision Mechanical and Optical Industries A
GHWP Global Harmonization Working Party 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
EC - European Commission European Commission C
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

Tel: +1 703 525 48 90
Fax: +1 703 276 07 93

  2. Taking part
  3. Who develops standards
  4. Technical Committees
  5. ISO/TC 210