Информация

  • Секретариат: ANSI (United States)
    Менеджер комитета:
    Mr Amir Aboutaleb
  • Председатель (до конца 2025):
    Mr Scott A. Colburn
  • Менеджер ИСО по техническим программам [TPM]:
    Mrs Kirsi Silander-van Hunen
    Менеджер ИСО по редакционным программам [EM]:
    Ms Valeria Agamennone
  • 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.

ISO/TC 210
Для получения дополнительной информации перейдите на веб-сайт технического комитета.

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Цели в области устойчивого развития

Данный комитет занимается разработкой 10 стандарта для достижения следующихЦели в области устойчивого развития:

3
Хорошее здоровье и благополучие
9
Индустриализация, инновации и инфраструктура
10
Уменьшение неравенства
31

Опубликованных стандартов *

12

Стандартов ИСО, находящихся *

40
Полноправных членов
29
Наблюдатели

* число включает обновленную информацию

Ссылки Заголовок Тип
ISO/TC 210/AHG   Ad-hoc group for ISO 22740 Рабочая группа
ISO/TC 210/AHG 3   Review of handbook for ISO 13485 Рабочая группа
ISO/TC 210/AHG 4   Assessment of ISO 13485 Рабочая группа
ISO/TC 210/AHG 5   Collaboration with IMDRF on guidance documents Рабочая группа
ISO/TC 210/AHG 6   Monitoring of PMS Рабочая группа
ISO/TC 210/ATTF   Arabic translation task force Рабочая группа
ISO/TC 210/CAG   Chair Advisory Group Рабочая группа
ISO/TC 210/JWG 1   Joint ISO/TC 210-IEC/SC 62A WG : Application of risk management to medical devices Рабочая группа
ISO/TC 210/JWG 2   Joint ISO/TC 210-IEC/SC 62A WG : Medical device software Рабочая группа
ISO/TC 210/JWG 3   Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability Рабочая группа
ISO/TC 210/JWG 4   Joint ISO/TC 210 - IEC/SC 62D WG: Small bore connectors Рабочая группа
ISO/TC 210/STTF   Spanish translation task force Рабочая группа
ISO/TC 210/TG 1   Review of Strategic Business Plan Рабочая группа
ISO/TC 210/WG 1   Application of quality systems to medical devices Рабочая группа
ISO/TC 210/WG 2   General aspects stemming from the application of quality principles to medical devices Рабочая группа
ISO/TC 210/WG 3   Symbols and nomenclature for medical devices Рабочая группа
ISO/TC 210/WG 5   Connectors for reservoir delivery systems Рабочая группа
ISO/TC 210/WG 6   Application of post market surveillance systems to medical devices Рабочая группа
ISO/TC 210/WG 7   Good engineering maintenance management Рабочая группа
Комитет по рабочим связям с ISO/TC 210

Комитет, указанный ниже, имеет доступ к следующим документам ISO/TC 210:

Ссылка Заголовок ИСО/МЭК
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
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
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
EC - European Commission European Commission C
GEDSA The Global Enteral Device Supplier Association C
Дата Меяц Местоположение ТК/ПК Примечание
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)

Association for the Advancement of Medical Instrumentation
901 N. Glebe Road, Suite 300
Arlington 22203 VA
United States

Tel: +1 703 525 48 90
Fax: +1 703 276 07 93

  2. Участие
  3. Кто разрабатывает стандарты
  4. Технические комитеты
  5. ISO/TC 210