ISO/TC 210
Quality management and corresponding general aspects for medical devices
About
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Secretariat: ANSI
Secretary: -
Chairperson (until end 2018):Mr P.W.J. Linders
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ISO Technical Programme Manager :ISO Editorial Programme Manager :
- Creation date: 1994
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.
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ISO/TC 210
Visit the Technical Committee's own website for more information.
This committee contributes with 2 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 electrical equipment used in medical practice | IEC |
| IEC/TC 56 | Dependability | IEC |
| IEC/TC 62 | Electrical equipment in medical practice | 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 215 | Health informatics | ISO |
| ISO/TC 262 | Risk management | ISO |
| ISO/TC 304 | Healthcare organization management | 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/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 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 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 |
| 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 |
| Date | Month | Location | TC/SC | Note |
|---|---|---|---|---|
| 12-16 | November 2018 | Seoul (Korea, Republic of) | ISO/TC 210 |
* Information definite but meeting not yet formally convened
** Provisional
ISO/TC 210 - Secretariat
ANSI United States
Association for the Advancement of Medical Instrumentation
4301 N. Fairfax Drive, Suite 301
Arlington, VA 22203-1633
United States
Arlington, VA 22203-1633
United States
Tel: +1 703 525 48 90
Fax: +1 703 276 07 93