About

Scope

Standardization of requirements and guidance in the field of quality management and corresponding general aspects for medical devices. Standards for small bore connectors.

Excluded:

  • generic quality management standards dealt with by ISO / TC 176;
  • quality management standards for pharmaceutical products;
  • technical requirements for specific types of medical devices (Note: Small bore connectors are components of a range of medical devices but are not themselves medical devices).

Note:

In order to promote global harmonization the technical committee may also develop standards on general aspects stemming from the application of quality principles to medical devices, where these are not covered by the scope of another technical committee.

ISO/TC 210
Visit the Technical Committee's own website for more information.

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Sustainable Development Goals

This committee contributes with 5 standards to the following Sustainable Development Goals:

32
published ISO standards *

under the direct responsibility of ISO/TC 210

7
ISO standards under development *

under the direct responsibility of ISO/TC 210

40
Participating members
26
Observing members

* number includes updates

Reference Title Type
ISO/TC 210/AHG   Ad-hoc group for ISO 22740 Working group
ISO/TC 210/AHG 3   Review of handbook for ISO 13485 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/AHG 6   Monitoring of PMS 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/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/CASCO Committee on conformity assessment ISO
ISO/IEC JTC 1/SC 7 Software and systems engineering 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 Clinical laboratory testing and in vitro diagnostic test 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

 

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 Clinical laboratory testing and in vitro diagnostic test 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
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