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Secretariat:
ANSI
Secretary: Ms. Hillary Woehrle
Chairperson: Dr. Eamonn V. Hoxey until end 2015
ISO Central Secretariat contact: Mrs Mary Lou Pelaprat
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 - Secretariat
United States (ANSI)
Address
Association for the Advancement of Medical Instrumentation
4301 N. Fairfax Drive, Suite 301
US-Arlington VA 22203-1633
Tel: +1 703 525 48 90
Fax: +1 703 276 07 93
Secretariat direct:
E-mail: hwoehrle@aami.org
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Subcommittees/Working Groups:
Subcommittee/Working Group Title ISO/TC 210/WG 1 Application of quality systems to medical devices
The convener can be reached through the secretariatISO/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 secretariatISO/TC 210/JWG 2 Joint ISO/TC 210-IEC/SC 62A WG : Medical device software
The convener can be reached through the secretariatISO/TC 210/WG 2 General aspects stemming from the application of quality principles to medical devices ISO/TC 210/WG 3 Symbols and nomenclature for medical devices
The convener can be reached through the secretariatISO/TC 210/JWG 3 Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability
The convener can be reached through the secretariatISO/TC 210/JWG 4 Joint ISO/TC 210-IEC/SC 62D: Small bore connectors
The convener can be reached through the secretariatISO/TC 210/WG 5 Small bore connectors ¿ reservoir delivery systems -
Liaison Committee to ISO/TC 210
The below committees may see the documents of ISO/TC 210 :
ISO committees in liaison:
ISO/IEC JTC 1/SC 7, ISO/TC 76, ISO/TC 84, ISO/TC 106, ISO/TC 121, ISO/TC 150, ISO/TC 157, ISO/TC 168, ISO/TC 170, ISO/TC 172/SC 7, ISO/TC 173, ISO/TC 173/SC 2, ISO/TC 176, ISO/TC 176/SC 2, ISO/TC 194, ISO/TC 198, ISO/TC 209, ISO/TC 212, ISO/TC 215
IEC committees in liaison:
IEC/TC 56, IEC/TC 62, IEC/SC 62A
Liaison Committee from ISO/TC 210
ISO/TC 210 can access the documents of the below committees :
ISO committees in liaison:
ISO/IEC JTC 1/SC 7, ISO/TC 76, ISO/TC 84, ISO/TC 106, ISO/TC 121, ISO/TC 145/SC 3, ISO/TC 150, ISO/TC 157, ISO/TC 168, ISO/TC 170, ISO/TC 172/SC 7, ISO/TC 173, ISO/TC 173/SC 2, ISO/TC 176, ISO/TC 176/SC 2, ISO/TC 194, ISO/TC 198, ISO/TC 209, ISO/TC 212, ISO/TC 215
Organizations in liaison:
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No meetings currently scheduled
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