袛谢褟 锌芯谢褍褔械薪懈褟 写芯锌芯谢薪懈褌械谢褜薪芯泄 懈薪褎芯褉屑邪褑懈懈 锌械褉械泄写懈褌械 薪邪 胁械斜-褋邪泄褌 褌械褏薪懈褔械褋泻芯谐芯 泻芯屑懈褌械褌邪.
袠薪褎芯褉屑邪褑懈褟
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小械泻褉械褌邪褉懈邪褌: ANSI
袦械薪械写卸械褉 泻芯屑懈褌械褌邪: -
袩褉械写褋械写邪褌械谢褜 (写芯 泻芯薪褑邪 2025):Mr Scott A. Colburn
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袦械薪械写卸械褉 袠小袨 锌芯 褌械褏薪懈褔械褋泻懈屑 锌褉芯谐褉邪屑屑邪屑 [TPM]:袦械薪械写卸械褉 袠小袨 锌芯 褉械写邪泻褑懈芯薪薪褘屑 锌褉芯谐褉邪屑屑邪屑 [EM]:
- 袛邪褌邪 褋芯蟹写邪薪懈褟 : 1994
袨斜谢邪褋褌褜 写械褟褌械谢褜薪芯褋褌懈
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.
袘褘褋褌褉褘泄 锌芯懈褋泻
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袪邪斜芯褔邪褟 锌褉芯谐褉邪屑屑邪
袩褉芯械泻褌褘 懈 薪芯胁褘械 褉邪斜芯褔懈械 褌械屑褘 -
袘懈蟹薪械褋-锌谢邪薪褘
袘懈蟹薪械褋-锌谢邪薪褘 孝袣 写谢褟 锌褍斜谢懈褔薪芯谐芯 褉邪褋褋屑芯褌褉械薪懈褟 -
袪邪斜芯褔懈械 写芯泻褍屑械薪褌褘 (褌褉械斜褍械褌褋褟 薪邪谢懈褔懈械 褍褔械褌薪芯泄 蟹邪锌懈褋懈)
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袠孝-懈薪褋褌褉褍屑械薪褌褘, 褉邪蟹褉邪斜芯褌邪薪薪褘械 写谢褟 锌芯写写械褉卸邪薪懈褟 锌褉芯褑械褋褋邪 褉邪蟹褉邪斜芯褌泻懈 褋褌邪薪写邪褉褌芯胁
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袩褍斜谢懈褔薪褘泄 泻芯薪褌械薪褌 谐褉褍锌锌褘
袩褉芯褋屑芯褌褉 写芯泻褍屑械薪褌芯胁, 锌褉械写芯褋褌邪胁谢械薪薪褘褏 写邪薪薪芯泄 谐褉褍锌锌芯泄
袛邪薪薪褘泄 泻芯屑懈褌械褌 蟹邪薪懈屑邪械褌褋褟 褉邪蟹褉邪斜芯褌泻芯泄 10 褋褌邪薪写邪褉褌邪 写谢褟 写芯褋褌懈卸械薪懈褟 褋谢械写褍褞褖懈褏笑械谢懈 胁 芯斜谢邪褋褌懈 褍褋褌芯泄褔懈胁芯谐芯 褉邪蟹胁懈褌懈褟:
| 小褋褘谢泻懈 | 袟邪谐芯谢芯胁芯泻 | 孝懈锌 |
|---|---|---|
| 香港六合彩开奖/TC 210/AHG 褋械泻褉械褌邪褉懈邪褌." 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 | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/AHG 3 褋械泻褉械褌邪褉懈邪褌." 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 | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/AHG 4 褋械泻褉械褌邪褉懈邪褌." 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 | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/AHG 5 褋械泻褉械褌邪褉懈邪褌." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Collaboration with IMDRF on guidance documents | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/AHG 6 褋械泻褉械褌邪褉懈邪褌." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Monitoring of PMS | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/ATTF 褋械泻褉械褌邪褉懈邪褌." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Arabic translation task force | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/CAG 褋械泻褉械褌邪褉懈邪褌." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Chair Advisory Group | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/JWG 1 褋械泻褉械褌邪褉懈邪褌." 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 | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/JWG 2 褋械泻褉械褌邪褉懈邪褌." 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 | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/JWG 3 褋械泻褉械褌邪褉懈邪褌." 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 | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/JWG 4 褋械泻褉械褌邪褉懈邪褌." 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 | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/STTF 褋械泻褉械褌邪褉懈邪褌." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Spanish translation task force | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/TG 1 褋械泻褉械褌邪褉懈邪褌." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Review of Strategic Business Plan | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/WG 1 褋械泻褉械褌邪褉懈邪褌." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Application of quality systems to medical devices | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/WG 2 褋械泻褉械褌邪褉懈邪褌." 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 | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/WG 3 褋械泻褉械褌邪褉懈邪褌." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Symbols and nomenclature for medical devices | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/WG 5 褋械泻褉械褌邪褉懈邪褌." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Connectors for reservoir delivery systems | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
| 香港六合彩开奖/TC 210/WG 7 褋械泻褉械褌邪褉懈邪褌." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Good engineering maintenance management | 袪邪斜芯褔邪褟 谐褉褍锌锌邪 |
袣芯屑懈褌械褌 锌芯 褉邪斜芯褔懈屑 褋胁褟蟹褟屑 褋 香港六合彩开奖/TC 210
袣芯屑懈褌械褌, 褍泻邪蟹邪薪薪褘泄 薪懈卸械, 懈屑械械褌 写芯褋褌褍锌 泻 褋谢械写褍褞褖懈屑 写芯泻褍屑械薪褌邪屑 香港六合彩开奖/TC 210:
| 小褋褘谢泻邪 | 袟邪谐芯谢芯胁芯泻 | 袠小袨/袦协袣 |
|---|---|---|
| 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 |
袣芯屑懈褌械褌褘 锌芯 褉邪斜芯褔懈屑 褋胁褟蟹褟屑 香港六合彩开奖/TC 210
香港六合彩开奖/TC 210 屑芯卸薪芯 锌芯谢褍褔懈褌褜 写芯褋褌褍锌 泻 写芯泻褍屑械薪褌邪屑 泻芯屑懈褌械褌芯胁 薪懈卸械
| 小褋褘谢泻邪 | 袟邪谐芯谢芯胁芯泻 | 袠小袨/袦协袣 |
|---|---|---|
| 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 |
袪邪斜芯褔懈械 褋胁褟蟹懈 (袣邪褌械谐芯褉懈懈 袗 懈 B)
| 袗泻褉芯薪懈屑 | 袟邪谐芯谢芯胁芯泻 | 孝懈锌 褉邪斜芯褔械泄 褋胁褟蟹懈 |
|---|---|---|
| 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 |
袪邪斜芯褔懈械 褋胁褟蟹懈 (袣邪褌械谐芯褉懈懈 小)
袪邪斜芯褔懈械 褋胁褟蟹懈 泻邪褌械谐芯褉懈泄 C, 锌褉懈褋褍褌褋褌胁褍褞褖懈褏 胁 袪邪斜芯褔械泄 谐褉褍锌锌械
| 袗泻褉芯薪懈屑 | 袟邪谐芯谢芯胁芯泻 | 孝懈锌 褉邪斜芯褔械泄 褋胁褟蟹懈 |
|---|---|---|
| GEDSA | The Global Enteral Device Supplier Association | C |
| 袛邪褌邪 | 袦械褟褑 | 袦械褋褌芯锌芯谢芯卸械薪懈械 | 孝袣/袩袣 | 袩褉懈屑械褔邪薪懈械 |
|---|---|---|---|---|
| 3-7 | March 2025 | Minato City (Japan) | 香港六合彩开奖/TC 210 |
* 袠薪褎芯褉屑邪褑懈褟 芯锌褉械写械谢械薪邪, 薪芯 蟹邪褋械写邪薪懈械 械褖械 芯褎懈褑懈邪谢褜薪芯 薪械 锌褉芯胁械写械薪芯
** 袩褉械写胁邪褉懈褌械谢褜薪芯械
香港六合彩开奖/TC 210 - 小械泻褉械褌邪褉懈邪褌
ANSI [United States]
Association for the Advancement of Medical Instrumentation
901 N. Glebe Road, Suite 300
Arlington 22203 VA
United States
Arlington 22203 VA
United States
Tel: +1 703 525 48 90
Fax: +1 703 276 07 93
香港六合彩开奖/TC 210 胁 薪芯胁芯褋褌褟褏
袧械 芯褋褌邪胁谢褟褟 屑械褋褌邪 写谢褟 芯褕懈斜芯泻.
袪械褕械薪懈械 褋褍褖械褋褌胁褍褞褖懈褏 锌褉芯斜谢械屑 锌褉懈 芯写薪芯胁褉械屑械薪薪芯屑 锌芯胁褘褕械薪懈懈 斜械蟹芯锌邪褋薪芯褋褌懈 懈 锌褉芯懈蟹胁芯写懈褌械谢褜薪芯褋褌懈 锌褉芯写褍泻褑懈懈.
小薪懈卸械薪懈械 褉懈褋泻芯胁, 褋胁褟蟹邪薪薪褘褏 褋 屑械写懈褑懈薪褋泻懈屑 芯斜芯褉褍写芯胁邪薪懈械屑, 褟胁谢褟械褌褋褟 褑械谢褜褞 泻谢褞褔械胁芯谐芯 芯褌褉邪褋谢械胁芯谐芯 褋褌邪薪写邪褉褌邪 香港六合彩开奖 14971. 孝芯谢褜泻芯 褔褌芯 芯斜薪芯胁谢械薪芯 锌芯写褉芯斜薪芯械 褉褍泻芯胁芯写褋褌胁芯 锌芯 芯锌褌懈屑懈蟹邪褑懈懈 械谐芯 懈褋锌芯谢褜蟹芯胁邪薪懈褟.
袩褉邪泻褌懈褔械褋泻懈 薪懈 芯写薪邪 屑械写懈褑懈薪褋泻邪褟 锌褉芯褑械写褍褉邪 薪械 芯斜褏芯写懈褌褋褟 斜械蟹 褉懈褋泻邪, 薪芯 褋褍褖械褋褌胁褍械褌 屑薪芯谐芯 褋锌芯褋芯斜芯胁 懈褏 屑懈薪懈屑懈蟹邪褑懈懈. 袨写薪懈屑 懈蟹 褌邪泻懈褏 褋锌芯褋芯斜芯胁 褟胁谢褟械褌褋褟 锌褉懈屑械薪械薪懈械 褉邪褑懈芯薪邪谢褜薪褘褏 锌褉芯褑械褋褋芯胁 褍锌褉邪胁谢械薪懈褟 褉懈褋泻邪屑懈 胁 芯褌薪芯褕械薪懈懈 …
袨泻芯谢芯 锌芯谢芯胁懈薪褘 薪邪褋械谢械薪懈褟 屑懈褉邪 锌芯-锌褉械卸薪械屑褍 薪械 懈屑械械褌 写芯褋褌褍锌邪 泻 褍褋谢褍谐邪屑 蟹写褉邪胁芯芯褏褉邪薪械薪懈褟. 袣褉芯屑械 褌芯谐芯, 胁 蟹邪胁懈褋懈屑芯褋褌懈 芯褌 屑械褋褌邪 锌褉芯卸懈胁邪薪懈褟 泻邪褔械褋褌胁芯 芯泻邪蟹褘胁邪械屑褘褏 褍褋谢褍谐 褉邪蟹谢懈褔邪械褌褋褟. 袦薪芯谐懈械 褋械屑褜懈 胁褘薪褍卸写械薪褘 胁褘斜懈褉邪褌褜 …