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 ISO / 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 -
Рабочая область
Рабочие документы (требуется наличие учетной записи) -
Электронные приложения ИСО
ИТ-инструменты, разработанные для поддержания процесса разработки стандартов -
Публичный контент группы
Просмотр документов, предоставленных данной группой
Данный комитет занимается разработкой 10 стандарта для достижения следующихЦели в области устойчивого развития:
Комитет по рабочим связям с ISO/TC 210
Комитет, указанный ниже, имеет доступ к следующим документам ISO/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 |
ISO/IEC JTC 1/SC 7 | Software and systems engineering | ISO/IEC |
ISO/IEC JTC 1/SC 42 | Artificial intelligence | ISO/IEC |
ISO/TC 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | ISO |
ISO/TC 84 | Devices for administration of medicinal products and catheters | ISO |
ISO/TC 106 | Dentistry | ISO |
ISO/TC 121 | Anaesthetic and respiratory equipment | ISO |
ISO/TC 150 | Implants for surgery | ISO |
ISO/TC 150/SC 2 | Cardiovascular implants and extracorporeal systems | ISO |
ISO/TC 157 | Non-systemic contraceptives and STI barrier prophylactics | ISO |
ISO/TC 168 | Prosthetics and orthotics | ISO |
ISO/TC 170 | Surgical instruments | ISO |
ISO/TC 172/SC 5 | Microscopes and endoscopes | ISO |
ISO/TC 172/SC 7 | Ophthalmic optics and instruments | ISO |
ISO/TC 173 | Assistive products | ISO |
ISO/TC 173/SC 2 | Classification and terminology | ISO |
ISO/TC 176 | Quality management and quality assurance | ISO |
ISO/TC 176/SC 2 | Quality systems | ISO |
ISO/TC 194 | Biological and clinical evaluation of medical devices | ISO |
ISO/TC 198 | Sterilization of health care products | ISO |
ISO/TC 209 | Cleanrooms and associated controlled environments | ISO |
ISO/TC 212 | Medical laboratories and in vitro diagnostic systems | ISO |
ISO/TC 262 | Risk management | ISO |
ISO/TC 289 | Brand evaluation | ISO |
ISO/TC 304 | Healthcare organization management | ISO |
ISO/TC 314 | Ageing societies | ISO |
ISO/TC 338 | Menstrual products | ISO |
Комитеты по рабочим связям ISO/TC 210
ISO/TC 210 можно получить доступ к документам комитетов ниже
Ссылка | Заголовок | ИСО/МЭК |
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ISO/CASCO | Committee on conformity assessment | ISO |
ISO/IEC JTC 1/SC 7 | Software and systems engineering | ISO/IEC |
ISO/IEC JTC 1/SC 42 | Artificial intelligence | ISO/IEC |
ISO/TC 76 | Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use | ISO |
ISO/TC 84 | Devices for administration of medicinal products and catheters | ISO |
ISO/TC 106 | Dentistry | ISO |
ISO/TC 121 | Anaesthetic and respiratory equipment | ISO |
ISO/TC 145/SC 3 | Graphical symbols for use on equipment | ISO |
ISO/TC 150 | Implants for surgery | ISO |
ISO/TC 150/SC 2 | Cardiovascular implants and extracorporeal systems | ISO |
ISO/TC 150/SC 6 | Active implants | ISO |
ISO/TC 157 | Non-systemic contraceptives and STI barrier prophylactics | ISO |
ISO/TC 168 | Prosthetics and orthotics | ISO |
ISO/TC 170 | Surgical instruments | ISO |
ISO/TC 172/SC 7 | Ophthalmic optics and instruments | ISO |
ISO/TC 173 | Assistive products | ISO |
ISO/TC 173/SC 2 | Classification and terminology | ISO |
ISO/TC 176 | Quality management and quality assurance | ISO |
ISO/TC 176/SC 1 | Concepts and terminology | ISO |
ISO/TC 176/SC 2 | Quality systems | ISO |
ISO/TC 194 | Biological and clinical evaluation of medical devices | ISO |
ISO/TC 198 | Sterilization of health care products | ISO |
ISO/TC 209 | Cleanrooms and associated controlled environments | ISO |
ISO/TC 212 | Medical laboratories and in vitro diagnostic systems | ISO |
ISO/TC 215 | Health informatics | ISO |
ISO/TC 262 | Risk management | ISO |
ISO/TC 289 | Brand evaluation | ISO |
ISO/TC 304 | Healthcare organization management | ISO |
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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EC - European Commission | European Commission | C |
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) | ISO/TC 210 |
* Информация определена, но заседание еще официально не проведено
** Предварительное
ISO/TC 210 - Секретариат
ANSI [United States]
Arlington 22203 VA
United States