Информация

• Секретариат: ANSI (United States)

  Менеджер комитета:

  Mr Amir Aboutaleb
• Председатель (до конца 2025):

  Mr Scott A. Colburn
• Менеджер ИСО по техническим программам [TPM]:

  Mrs Kirsi Silander-van Hunen
  Менеджер ИСО по редакционным программам [EM]:

  Ms Valeria Agamennone
• Дата создания : 1994

Область деятельности

Standardization of requirements and guidance in the field of quality management and corresponding general aspects, for products with a health purpose, including connectors for liquid and gases.

Excluded:

• generic quality management standards dealt with by ISO / TC 176;
• quality management standards for pharmaceutical products and healthcare services;

Note: Products with a health purpose include products for use in relation to health, including medical devices, adjacent products [or could also say accessories] and those with a risk profile similar to medical devices.