Информация
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Секретариат: ANSI
Менеджер комитета: -
Председатель (до конца 2025):Mr Scott A. Colburn
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Менеджер ИСО по техническим программам [TPM]:Менеджер ИСО по редакционным программам [EM]:
- Дата создания : 1994
Область деятельности
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 ϲʿ / 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.
Быстрый поиск
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Рабочая программа
Проекты и новые рабочие темы -
Бизнес-планы
Бизнес-планы ТК для публичного рассмотрения -
Рабочие документы (требуется наличие учетной записи)
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ИТ-инструменты, разработанные для поддержания процесса разработки стандартов
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Публичный контент группы
Просмотр документов, предоставленных данной группой
Данный комитет занимается разработкой 10 стандарта для достижения следующихЦели в области устойчивого развития:
Ссылки | Заголовок | Тип |
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ϲʿ/TC 210/AHG секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Ad-hoc group for ϲʿ 22740 | Рабочая группа |
ϲʿ/TC 210/AHG 3 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Review of handbook for ϲʿ 13485 | Рабочая группа |
ϲʿ/TC 210/AHG 4 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Assessment of ϲʿ 13485 | Рабочая группа |
ϲʿ/TC 210/AHG 5 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Collaboration with IMDRF on guidance documents | Рабочая группа |
ϲʿ/TC 210/AHG 6 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Monitoring of PMS | Рабочая группа |
ϲʿ/TC 210/ATTF секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Arabic translation task force | Рабочая группа |
ϲʿ/TC 210/CAG секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Chair Advisory Group | Рабочая группа |
ϲʿ/TC 210/JWG 1 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Joint ϲʿ/TC 210-IEC/SC 62A WG : Application of risk management to medical devices | Рабочая группа |
ϲʿ/TC 210/JWG 2 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Joint ϲʿ/TC 210-IEC/SC 62A WG : Medical device software | Рабочая группа |
ϲʿ/TC 210/JWG 3 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Joint ϲʿ/TC 210-IEC/SC 62A WG : Medical device usability | Рабочая группа |
ϲʿ/TC 210/JWG 4 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Joint ϲʿ/TC 210 - IEC/SC 62D WG: Small bore connectors | Рабочая группа |
ϲʿ/TC 210/STTF секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Spanish translation task force | Рабочая группа |
ϲʿ/TC 210/TG 1 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Review of Strategic Business Plan | Рабочая группа |
ϲʿ/TC 210/WG 1 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Application of quality systems to medical devices | Рабочая группа |
ϲʿ/TC 210/WG 2 секретариат." 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 | Рабочая группа |
ϲʿ/TC 210/WG 3 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Symbols and nomenclature for medical devices | Рабочая группа |
ϲʿ/TC 210/WG 5 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Connectors for reservoir delivery systems | Рабочая группа |
ϲʿ/TC 210/WG 7 секретариат." data-bs-placement="top" data-bs-trigger="focus" role="button" tabindex="0" data-bs-html="true"> | Good engineering maintenance management | Рабочая группа |
Комитет по рабочим связям с ϲʿ/TC 210
Комитет, указанный ниже, имеет доступ к следующим документам ϲʿ/TC 210:
Ссылка | Заголовок | ИСО/МЭК |
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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 |
ϲʿ/IEC JTC 1/SC 7 | Software and systems engineering | ϲʿ/IEC |
ϲʿ/IEC JTC 1/SC 42 | Artificial intelligence | ϲʿ/IEC |
ϲʿ/TC 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | ϲʿ |
ϲʿ/TC 84 | Devices for administration of medicinal products and catheters | ϲʿ |
ϲʿ/TC 106 | Dentistry | ϲʿ |
ϲʿ/TC 121 | Anaesthetic and respiratory equipment | ϲʿ |
ϲʿ/TC 150 | Implants for surgery | ϲʿ |
ϲʿ/TC 150/SC 2 | Cardiovascular implants and extracorporeal systems | ϲʿ |
ϲʿ/TC 157 | Non-systemic contraceptives and STI barrier prophylactics | ϲʿ |
ϲʿ/TC 168 | Prosthetics and orthotics | ϲʿ |
ϲʿ/TC 170 | Surgical instruments | ϲʿ |
ϲʿ/TC 172/SC 5 | Microscopes and endoscopes | ϲʿ |
ϲʿ/TC 172/SC 7 | Ophthalmic optics and instruments | ϲʿ |
ϲʿ/TC 173 | Assistive products | ϲʿ |
ϲʿ/TC 173/SC 2 | Classification and terminology | ϲʿ |
ϲʿ/TC 176 | Quality management and quality assurance | ϲʿ |
ϲʿ/TC 176/SC 2 | Quality systems | ϲʿ |
ϲʿ/TC 194 | Biological and clinical evaluation of medical devices | ϲʿ |
ϲʿ/TC 198 | Sterilization of health care products | ϲʿ |
ϲʿ/TC 209 | Cleanrooms and associated controlled environments | ϲʿ |
ϲʿ/TC 212 | Medical laboratories and in vitro diagnostic systems | ϲʿ |
ϲʿ/TC 262 | Risk management | ϲʿ |
ϲʿ/TC 289 | Brand evaluation | ϲʿ |
ϲʿ/TC 304 | Healthcare organization management | ϲʿ |
ϲʿ/TC 314 | Ageing societies | ϲʿ |
ϲʿ/TC 338 | Menstrual products | ϲʿ |
Комитеты по рабочим связям ϲʿ/TC 210
ϲʿ/TC 210 можно получить доступ к документам комитетов ниже
Ссылка | Заголовок | ИСО/МЭК |
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ϲʿ/CASCO | Committee on conformity assessment | ϲʿ |
ϲʿ/IEC JTC 1/SC 7 | Software and systems engineering | ϲʿ/IEC |
ϲʿ/IEC JTC 1/SC 42 | Artificial intelligence | ϲʿ/IEC |
ϲʿ/TC 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | ϲʿ |
ϲʿ/TC 84 | Devices for administration of medicinal products and catheters | ϲʿ |
ϲʿ/TC 106 | Dentistry | ϲʿ |
ϲʿ/TC 121 | Anaesthetic and respiratory equipment | ϲʿ |
ϲʿ/TC 145/SC 3 | Graphical symbols for use on equipment | ϲʿ |
ϲʿ/TC 150 | Implants for surgery | ϲʿ |
ϲʿ/TC 150/SC 2 | Cardiovascular implants and extracorporeal systems | ϲʿ |
ϲʿ/TC 150/SC 6 | Active implants | ϲʿ |
ϲʿ/TC 157 | Non-systemic contraceptives and STI barrier prophylactics | ϲʿ |
ϲʿ/TC 168 | Prosthetics and orthotics | ϲʿ |
ϲʿ/TC 170 | Surgical instruments | ϲʿ |
ϲʿ/TC 172/SC 7 | Ophthalmic optics and instruments | ϲʿ |
ϲʿ/TC 173 | Assistive products | ϲʿ |
ϲʿ/TC 173/SC 2 | Classification and terminology | ϲʿ |
ϲʿ/TC 176 | Quality management and quality assurance | ϲʿ |
ϲʿ/TC 176/SC 1 | Concepts and terminology | ϲʿ |
ϲʿ/TC 176/SC 2 | Quality systems | ϲʿ |
ϲʿ/TC 194 | Biological and clinical evaluation of medical devices | ϲʿ |
ϲʿ/TC 198 | Sterilization of health care products | ϲʿ |
ϲʿ/TC 209 | Cleanrooms and associated controlled environments | ϲʿ |
ϲʿ/TC 212 | Medical laboratories and in vitro diagnostic systems | ϲʿ |
ϲʿ/TC 215 | Health informatics | ϲʿ |
ϲʿ/TC 262 | Risk management | ϲʿ |
ϲʿ/TC 289 | Brand evaluation | ϲʿ |
ϲʿ/TC 304 | Healthcare organization management | ϲʿ |
Рабочие связи (Категории А и B)
Акроним | Заголовок | Тип рабочей связи |
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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 |
Рабочие связи (Категории С)
Рабочие связи категорий C, присутствующих в Рабочей группе
Акроним | Заголовок | Тип рабочей связи |
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GEDSA | The Global Enteral Device Supplier Association | C |
Дата | Меяц | Местоположение | ТК/ПК | Примечание |
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3-7 | March 2025 | Minato City (Japan) | ϲʿ/TC 210 |
* Информация определена, но заседание еще официально не проведено
** Предварительное
ϲʿ/TC 210 - Секретариат
ANSI [United States]
Arlington 22203 VA
United States