ISO/TC 194
Biological and clinical evaluation of medical devices
Информация
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Секретариат: DIN
Секретариат: -
Председатель (до конца 2023):Jeremy Tinkler
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Менеджер ИСО по техническим программам :Менеджер ИСО по редакционным программам :
- 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
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Проекты и новые рабочие темы
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Бизнес-планы ТК для публичного рассмотрения
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по ИСО/ТК и общественным информационным материалам
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ИТ-инструменты, разработанные для поддержания процесса разработки стандартов
Данный комитет занимается разработкой 4 стандарта для достижения следующих Цель устойчивого развития:
| 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 | Optics and photonics | 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
Tel: +49 30 26 01-0
Fax: +49 30 26 01 12 31
Web: http://www.din.de
Секретариат:
Mr Dipl.-Ing Karl Wenzelewski
Tel: +49 7231 9188-24
Fax: +49 7231 9188-33
Email: karl.wenzelewski@din.de