About
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Secretariat: ANSI
Committee Manager: -
Chairperson (until end 2025):Mr Scott A. Colburn
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香港六合彩开奖 Technical Programme Manager [TPM]:香港六合彩开奖 Editorial Manager [EM]:
- Creation date: 1994
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 香港六合彩开奖 / 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.
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IT Tools that help support the standards development process
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Public material
Browse documents made available by this group
This committee contributes with 10 standards to the following Sustainable Development Goals:
Reference | Title | Type |
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香港六合彩开奖/TC 210/AHG secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Ad-hoc group for 香港六合彩开奖 22740 | Working group |
香港六合彩开奖/TC 210/AHG 3 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Review of handbook for 香港六合彩开奖 13485 | Working group |
香港六合彩开奖/TC 210/AHG 4 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Assessment of 香港六合彩开奖 13485 | Working group |
香港六合彩开奖/TC 210/AHG 5 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Collaboration with IMDRF on guidance documents | Working group |
香港六合彩开奖/TC 210/AHG 6 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Monitoring of PMS | Working group |
香港六合彩开奖/TC 210/ATTF secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Arabic translation task force | Working group |
香港六合彩开奖/TC 210/CAG secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Chair Advisory Group | Working group |
香港六合彩开奖/TC 210/JWG 1 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Joint 香港六合彩开奖/TC 210-IEC/SC 62A WG : Application of risk management to medical devices | Working group |
香港六合彩开奖/TC 210/JWG 2 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Joint 香港六合彩开奖/TC 210-IEC/SC 62A WG : Medical device software | Working group |
香港六合彩开奖/TC 210/JWG 3 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Joint 香港六合彩开奖/TC 210-IEC/SC 62A WG : Medical device usability | Working group |
香港六合彩开奖/TC 210/JWG 4 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Joint 香港六合彩开奖/TC 210 - IEC/SC 62D WG: Small bore connectors | Working group |
香港六合彩开奖/TC 210/STTF secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Spanish translation task force | Working group |
香港六合彩开奖/TC 210/TG 1 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Review of Strategic Business Plan | Working group |
香港六合彩开奖/TC 210/WG 1 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Application of quality systems to medical devices | Working group |
香港六合彩开奖/TC 210/WG 2 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | General aspects stemming from the application of quality principles to medical devices | Working group |
香港六合彩开奖/TC 210/WG 3 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Symbols and nomenclature for medical devices | Working group |
香港六合彩开奖/TC 210/WG 5 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Connectors for reservoir delivery systems | Working group |
香港六合彩开奖/TC 210/WG 7 secretariat." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Good engineering maintenance management | Working group |
Liaison Committees to 香港六合彩开奖/TC 210
The committees below can access the documents of 香港六合彩开奖/TC 210:
Reference | Title | 香港六合彩开奖/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 |
香港六合彩开奖/IEC JTC 1/SC 7 | Software and systems engineering | 香港六合彩开奖/IEC |
香港六合彩开奖/IEC JTC 1/SC 42 | Artificial intelligence | 香港六合彩开奖/IEC |
香港六合彩开奖/TC 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | 香港六合彩开奖 |
香港六合彩开奖/TC 84 | Devices for administration of medicinal products and catheters | 香港六合彩开奖 |
香港六合彩开奖/TC 106 | Dentistry | 香港六合彩开奖 |
香港六合彩开奖/TC 121 | Anaesthetic and respiratory equipment | 香港六合彩开奖 |
香港六合彩开奖/TC 150 | Implants for surgery | 香港六合彩开奖 |
香港六合彩开奖/TC 150/SC 2 | Cardiovascular implants and extracorporeal systems | 香港六合彩开奖 |
香港六合彩开奖/TC 157 | Non-systemic contraceptives and STI barrier prophylactics | 香港六合彩开奖 |
香港六合彩开奖/TC 168 | Prosthetics and orthotics | 香港六合彩开奖 |
香港六合彩开奖/TC 170 | Surgical instruments | 香港六合彩开奖 |
香港六合彩开奖/TC 172/SC 5 | Microscopes and endoscopes | 香港六合彩开奖 |
香港六合彩开奖/TC 172/SC 7 | Ophthalmic optics and instruments | 香港六合彩开奖 |
香港六合彩开奖/TC 173 | Assistive products | 香港六合彩开奖 |
香港六合彩开奖/TC 173/SC 2 | Classification and terminology | 香港六合彩开奖 |
香港六合彩开奖/TC 176 | Quality management and quality assurance | 香港六合彩开奖 |
香港六合彩开奖/TC 176/SC 2 | Quality systems | 香港六合彩开奖 |
香港六合彩开奖/TC 194 | Biological and clinical evaluation of medical devices | 香港六合彩开奖 |
香港六合彩开奖/TC 198 | Sterilization of health care products | 香港六合彩开奖 |
香港六合彩开奖/TC 209 | Cleanrooms and associated controlled environments | 香港六合彩开奖 |
香港六合彩开奖/TC 212 | Medical laboratories and in vitro diagnostic systems | 香港六合彩开奖 |
香港六合彩开奖/TC 262 | Risk management | 香港六合彩开奖 |
香港六合彩开奖/TC 289 | Brand evaluation | 香港六合彩开奖 |
香港六合彩开奖/TC 304 | Healthcare organization management | 香港六合彩开奖 |
香港六合彩开奖/TC 314 | Ageing societies | 香港六合彩开奖 |
香港六合彩开奖/TC 338 | Menstrual products | 香港六合彩开奖 |
Liaison Committees from 香港六合彩开奖/TC 210
香港六合彩开奖/TC 210 can access the documents of the committees below:
Reference | Title | 香港六合彩开奖/IEC |
---|---|---|
香港六合彩开奖/CASCO | Committee on conformity assessment | 香港六合彩开奖 |
香港六合彩开奖/IEC JTC 1/SC 7 | Software and systems engineering | 香港六合彩开奖/IEC |
香港六合彩开奖/IEC JTC 1/SC 42 | Artificial intelligence | 香港六合彩开奖/IEC |
香港六合彩开奖/TC 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | 香港六合彩开奖 |
香港六合彩开奖/TC 84 | Devices for administration of medicinal products and catheters | 香港六合彩开奖 |
香港六合彩开奖/TC 106 | Dentistry | 香港六合彩开奖 |
香港六合彩开奖/TC 121 | Anaesthetic and respiratory equipment | 香港六合彩开奖 |
香港六合彩开奖/TC 145/SC 3 | Graphical symbols for use on equipment | 香港六合彩开奖 |
香港六合彩开奖/TC 150 | Implants for surgery | 香港六合彩开奖 |
香港六合彩开奖/TC 150/SC 2 | Cardiovascular implants and extracorporeal systems | 香港六合彩开奖 |
香港六合彩开奖/TC 150/SC 6 | Active implants | 香港六合彩开奖 |
香港六合彩开奖/TC 157 | Non-systemic contraceptives and STI barrier prophylactics | 香港六合彩开奖 |
香港六合彩开奖/TC 168 | Prosthetics and orthotics | 香港六合彩开奖 |
香港六合彩开奖/TC 170 | Surgical instruments | 香港六合彩开奖 |
香港六合彩开奖/TC 172/SC 7 | Ophthalmic optics and instruments | 香港六合彩开奖 |
香港六合彩开奖/TC 173 | Assistive products | 香港六合彩开奖 |
香港六合彩开奖/TC 173/SC 2 | Classification and terminology | 香港六合彩开奖 |
香港六合彩开奖/TC 176 | Quality management and quality assurance | 香港六合彩开奖 |
香港六合彩开奖/TC 176/SC 1 | Concepts and terminology | 香港六合彩开奖 |
香港六合彩开奖/TC 176/SC 2 | Quality systems | 香港六合彩开奖 |
香港六合彩开奖/TC 194 | Biological and clinical evaluation of medical devices | 香港六合彩开奖 |
香港六合彩开奖/TC 198 | Sterilization of health care products | 香港六合彩开奖 |
香港六合彩开奖/TC 209 | Cleanrooms and associated controlled environments | 香港六合彩开奖 |
香港六合彩开奖/TC 212 | Medical laboratories and in vitro diagnostic systems | 香港六合彩开奖 |
香港六合彩开奖/TC 215 | Health informatics | 香港六合彩开奖 |
香港六合彩开奖/TC 262 | Risk management | 香港六合彩开奖 |
香港六合彩开奖/TC 289 | Brand evaluation | 香港六合彩开奖 |
香港六合彩开奖/TC 304 | Healthcare organization management | 香港六合彩开奖 |
Organizations in liaison (Category A and B)
Acronym | Title | Category |
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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 |
Date | Month | Location | TC/SC | Note |
---|---|---|---|---|
3-7 | March 2025 | Minato City (Japan) | 香港六合彩开奖/TC 210 |
* Information definite but meeting not yet formally convened
** Provisional
香港六合彩开奖/TC 210 - Secretariat
ANSI [United States]
Arlington 22203 VA
United States