Информация

  • Секретариат: DIN
    Менеджер комитета:
    Mrs Dr Susann Minkwitz
  • Председатель (до конца 2023):
    Mr Jeremy Tinkler
  • Менеджер ИСО по техническим программам [TPM]:
    Mme Patricia Cook
    Менеджер ИСО по редакционным [EM]:
    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.

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Цели в области устойчивого развития

Данный комитет занимается разработкой 27 стандарта для достижения следующихЦели в области устойчивого развития:

3
Хорошее здоровье и благополучие
9
Индустриализация, инновации и инфраструктура
36

Опубликованных стандартов *

10

Стандартов ИСО, находящихся *

33
Полноправных членов
19
Наблюдатели

* число включает обновленную информацию

Ссылки Заголовок Тип
ISO/TC 194/CAG   Chair's Advisory Group Working group
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
ISO/TC 194/WG 18   Attributes of medical devices relevant to biological risk assessment 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 products with a health purpose including 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
ISO/TC 338 Menstrual products 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 products with a health purpose including 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
VAMAS Versailles Project on Advanced Materials and Standards A
WHO World Health Organization A

Дата Меяц Местоположение ТК/ПК Примечание
23-27 October 2023 Arlington (United States) ISO/TC 194  

* Информация определена, но заседание еще официально не проведено
** Предварительное

ISO/TC 194 - Секретариат

DIN [Germany]

DIN Deutsches Institut für Normung e.V.
Am DIN-Platz, Burggrafenstraße 6
D-10787 Berlin
Germany

Tel: +49 30 2601-0
Fax: +49 30 26 01 12 31
Web:

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