Информация

  • Секретариат: ANSI
    Менеджер комитета:
    Mr Wil Vargas
  • Председатель (до конца 2021):
    Dr P.W.J. Linders
  • Менеджер ИСО по техническим программам [TPM]:
    Mr Ben Carson
    Менеджер ИСО по редакционным программам [EPM]:
    Ms Jasmin Lewis
  • Дата создания : 1994

Область деятельности

Standardization of requirements and guidance in the field of quality management and corresponding general aspects for medical devices. Standards for small bore connectors.

Excluded:

  • generic quality management standards dealt with by ISO / TC 176;
  • quality management standards for pharmaceutical products;
  • technical requirements for specific types of medical devices (Note: Small bore connectors are components of a range of medical devices but are not themselves medical devices).

Note:

In order to promote global harmonization the technical committee may also develop standards on general aspects stemming from the application of quality principles to medical devices, where these are not covered by the scope of another technical committee.

ISO/TC 210

Visitez le site du comité pour de plus amples informations.

Быстрый поиск

Цели в области устойчивого развития

Данный комитет занимается разработкой 1 стандарт для достижения следующих Цели в области устойчивого развития:

31

Опубликованных стандартов *

находящиеся в компетенции ISO/TC 210

7

Стандартов ИСО, находящихся *

находящиеся в компетенции ISO/TC 210

42

Полноправных членов

18

Наблюдатели

* число включает обновленную информацию

Ссылки Заголовок Тип
ISO/TC 210/AHG Ad-hoc group for ISO 22740 Working group
ISO/TC 210/AHG 1 High Level Structure Analysis Working group
ISO/TC 210/JWG 1 Joint ISO/TC 210-IEC/SC 62A WG : Application of risk management to medical devices Working group
ISO/TC 210/JWG 2 Joint ISO/TC 210-IEC/SC 62A WG : Medical device software Working group
ISO/TC 210/JWG 3 Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability Working group
ISO/TC 210/JWG 4 Joint ISO/TC 210 - IEC/SC 62D WG: Small bore connectors Working group
ISO/TC 210/WG 1 Application of quality systems to medical devices Working group
ISO/TC 210/WG 2 General aspects stemming from the application of quality principles to medical devices Working group
ISO/TC 210/WG 3 Symbols and nomenclature for medical devices Working group
ISO/TC 210/WG 5 Connectors for reservoir delivery systems Working group
ISO/TC 210/WG 6 Application of post market surveillance systems to medical devices Working group

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 electrical equipment used in medical practice IEC
IEC/TC 56 Dependability IEC
IEC/TC 62 Electrical equipment in medical practice IEC
ISO/CASCO Committee on conformity assessment ISO
ISO/IEC JTC 1/SC 7 Software and systems engineering 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 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 Clinical laboratory testing and in vitro diagnostic test systems ISO
ISO/TC 262 Risk management ISO
ISO/TC 289 Brand evaluation ISO
ISO/TC 304 Healthcare organization management 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/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 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 Clinical laboratory testing and in vitro diagnostic test systems ISO
ISO/TC 215 Health informatics 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
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
GEDSA The Global Enteral Device Supplier Association C
Дата Меяц Местоположение ТК/ПК Примечание
7-11 October 2019 London (United Kingdom) 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, VA 22203
United States

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

Секретариат:

Mr Wil Vargas
Tel: +1-703-647-2779
Fax: +1-703-276-0793