Информация

  • Секретариат: DIN
    Менеджер комитета:
    Mr Dipl.-Ing Karl Wenzelewski
  • Председатель (до конца 2023):
    Jeremy Tinkler
  • Менеджер ИСО по техническим программам [TPM]:
    Mme Patricia Cook
    Менеджер ИСО по редакционным программам [EPM]:
    Ms Sanjali Jain
  • Дата создания : 1988

Область деятельности

Standardization of the approach to biological and clinical evaluation of medical and dental materials and devices together with standardization of biological test methods applicable to those materials and devices as well as good clinical practice principles to clinical investigations in humans of those devices.

Быстрый поиск

Цели в области устойчивого развития

Данный комитет занимается разработкой 4 стандарта для достижения следующих Цель устойчивого развития:

3
Хорошее здоровье и благополучие
31

Опубликованных стандартов *

относящиеся к ТК и ПК

из которых 26 находящиеся в компетенции ISO/TC 194

9

Стандартов ИСО, находящихся *

находящиеся в компетенции ISO/TC 194

32

Полноправных членов

19

Наблюдатели

* число включает обновленную информацию

Ссылки Заголовок Тип
ISO/TC 194/SC 1 Tissue product safety Sub committee
ISO/TC 194/WG 1 Systematic approach to biological evaluation and terminology Working group
ISO/TC 194/WG 2 Degradation aspects related to biological testing Working group
ISO/TC 194/WG 3 Animal protection aspects Working group
ISO/TC 194/WG 4 Clinical investigations of medical devices in humans Working group
ISO/TC 194/WG 5 Cytotoxicity Working group
ISO/TC 194/WG 6 Mutagenicity, carcinogenicity and reproductive toxicity Working group
ISO/TC 194/WG 7 Systemic toxicity Working group
ISO/TC 194/WG 8 Irritation, sensitization Working group
ISO/TC 194/WG 9 Effects on blood Working group
ISO/TC 194/WG 10 Implantation Working group
ISO/TC 194/WG 11 Allowable limits for leachable substances Working group
ISO/TC 194/WG 12 Sample preparation and reference materials Working group
ISO/TC 194/WG 13 Toxicokinetics Working group
ISO/TC 194/WG 14 Material characterization Working group
ISO/TC 194/WG 15 Strategic approach to biological assessment Working group
ISO/TC 194/WG 16 Pyrogenicity Working group
ISO/TC 194/WG 17 Nanomaterials Working group

Комитет по рабочим связям с ISO/TC 194

Комитет, указанный ниже, имеет доступ к следующим документам ISO/TC 194:

Ссылка Заголовок ИСО/МЭК
IEC/TC 124 Wearable electronic devices and technologies 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 150 Implants for surgery ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems ISO
ISO/TC 150/SC 7 Tissue-engineered medical products ISO
ISO/TC 157 Non-systemic contraceptives and STI barrier prophylactics ISO
ISO/TC 172/SC 7 Ophthalmic optics and instruments ISO
ISO/TC 173 Assistive products ISO
ISO/TC 198 Sterilization of health care products ISO
ISO/TC 210 Quality management and corresponding general aspects for medical devices ISO
ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems ISO
ISO/TC 229 Nanotechnologies ISO
ISO/TC 304 Healthcare organization management ISO

 

Комитеты по рабочим связям ISO/TC 194

ISO/TC 194 можно получить доступ к документам комитетов ниже

Ссылка Заголовок ИСО/МЭК
IEC/TC 124 Wearable electronic devices and technologies IEC
ISO/TC 106 Dentistry ISO
ISO/TC 106/SC 2 Prosthodontic materials ISO
ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care 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 150/SC 7 Tissue-engineered medical products ISO
ISO/TC 198 Sterilization of health care products ISO
ISO/TC 210 Quality management and corresponding general aspects for medical devices ISO
ISO/TC 229 Nanotechnologies ISO
ISO/TC 304 Healthcare organization management ISO

 

Рабочие связи (Категории А и B)

Акроним Заголовок Тип рабочей связи
FDI World Dental Federation (FDI) A
MedTech Europe Alliance of European medical technology industry associations A
OECD Organisation for Economic Co-operation and Development, OECD A
OIE World Organization for Animal Health (OIE) A
WHO World Health Organization A

ISO/TC 194 - Секретариат

DIN [Germany]

DIN Deutsches Institut für Normung e.V.
Saatwinkler Damm 42/43
D-13627 Berlin
Germany

Tel: +49 30 26 01-0
Fax: +49 30 26 01 12 31
Web:

  2. Участие
  3. Кто разрабатывает стандарты
  4. Технические комитеты
  5. ISO/TC 194