TC 210
Quality management and corresponding general aspects for medical devices
- Secretariat: ANSI
- Secretary: Ms. Hillary Woehrle
- Chairperson: Dr. Eamonn V. Hoxey (United Kingdom) until end 2009
- Creation date: 1994
- Work programme
(drafts and new work items of TC 210)
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.
| Total number of published ISO standards related to the TC and its SCs: | 18 |
| Number of published ISO standards under the direct responsibility of TC 210: | 18 |
| Participating countries: | 30 |
| Observing countries: | 18 |
ISO committees in liaison:
JTC 1/SC 7, TC 76, TC 84, TC 106, TC 121, TC 145/SC 3, TC 150, TC 157, TC 168, TC 170, TC 172/SC 7, TC 173, TC 173/SC 2, TC 176, TC 176/SC 2, TC 194, TC 198, TC 209, TC 212, TC 215
IEC committees in liaison:
IEC/TC 56, IEC/TC 62, IEC/SC 62A
Organizations in liaison:
DITTA, EDMA, EUCOMED, EUROM, WHO
Subcommittees/Working Groups:
| Subcommittee/Working Group | Title |
|---|---|
| TC 210/WG 1 |
Application of quality systems to medical devices The convener can be reached through the secretariat |
| TC 210/JWG 1 |
Joint ISO/TC 210-IEC/SC 62A WG : Application of risk management to medical devices The convener can be reached through the secretariat |
| TC 210/JWG 2 |
Joint ISO/TC 210-IEC/SC 62A WG : Medical device software The convener can be reached through the secretariat |
| TC 210/WG 2 |
General aspects stemming from the application of quality principles to medical devices The convener can be reached through the secretariat |
| TC 210/WG 3 |
Symbols and nomenclature for medical devices The convener can be reached through the secretariat |
| TC 210/JWG 3 |
Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability The convener can be reached through the secretariat |
| TC 210/JWG 4 |
Joint ISO/TC 210-IEC/SC 62D: Small bore connectors The convener can be reached through the secretariat |
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