Информация

  • Секретариат: DIN
    Менеджер комитета:
    Mrs Dipl.-Ing Margarethe Boresch
  • Председатель (до конца 2024):
    Mr Marc von Pawlowski
  • Менеджер ИСО по техническим программам [TPM]:
    Ms Monica Ibido
    Менеджер ИСО по редакционным программам [EM]:
    Mrs Martha Casantosan
  • Дата создания : 1951

Область деятельности

Standardization of containers (such as infusion bottles and bags, injection vials, ampoules, glass cylinders, cartridges, prefillable syringes, etc.) application systems (such as giving sets, non-electrically driven portable infusion devices, blood collection systems, etc.) and accessories for infusion, transfusion, injection and blood processing in blood banks, terms, definitions, requirements and test methods for these devices, specifications and test methods for quality and performance of their materials and components (such as elastomeric closures, caps and ports, pipettes, etc.) and quality management systems for primary packaging materials.

Excluded:

  • performance requirements of metered devices and supplies intended for self-administration of medicinal products, non-prefilled syringes and needles and intravascular catheters, covered by ISO/TC 84;
  • devices intended for respiratory therapy, covered by ISO/TC 121;
  • dental cartridge syringe holder, covered by ISO/TC 106.

Быстрый поиск

85

Опубликованных стандартов *

20

Стандартов ИСО, находящихся *

23
Полноправных членов
23
Наблюдатели

* число включает обновленную информацию

Ссылки Заголовок Тип
ISO/TC 76/WG 1   Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment Рабочая группа
ISO/TC 76/WG 2   Rigid container systems and related accessories for parenterals and injectables Рабочая группа
ISO/TC 76/WG 4   Elastomeric parts and components and related secondary packaging components Рабочая группа
Комитет по рабочим связям с ISO/TC 76

Комитет, указанный ниже, имеет доступ к следующим документам ISO/TC 76:

Ссылка Заголовок ИСО/МЭК
IEC/SC 62D Particular medical equipment, software, and systems IEC
ISO/TC 48 Laboratory equipment ISO
ISO/TC 61/SC 9 Thermoplastic materials ISO
ISO/TC 63 Glass containers ISO
ISO/TC 84 Devices for administration of medicinal products and catheters ISO
ISO/TC 106/SC 4 Dental instruments ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems ISO
ISO/TC 176/SC 2 Quality systems 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 Medical laboratories and in vitro diagnostic systems ISO

 

Комитеты по рабочим связям ISO/TC 76

ISO/TC 76 можно получить доступ к документам комитетов ниже

Ссылка Заголовок ИСО/МЭК
ISO/TC 45/SC 2 Testing and analysis ISO
ISO/TC 61/SC 9 Thermoplastic materials ISO
ISO/TC 63 Glass containers ISO
ISO/TC 84 Devices for administration of medicinal products and catheters ISO
ISO/TC 106/SC 4 Dental instruments ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems 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 210 Quality management and corresponding general aspects for products with a health purpose including medical devices ISO
ISO/TC 212 Medical laboratories and in vitro diagnostic systems ISO

 

Рабочие связи (Категории А и B)
Акроним Заголовок Тип рабочей связи
EFLM European Federation of Clinical Chemistry and Laboratory Medicine A
WHO World Health Organization A

ISO/TC 76 - 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