International Standard
ISO 15747:2026
Plastic containers for intravenous injections
Reference number
ISO 15747:2026
Edition 4
2026-05
Preview
ISO 15747:2026
89249
недоступно на русском языке
Опубликовано (Версия 4, 2026)

ISO 15747:2026

ISO 15747:2026
89249
Язык
Формат
CHF 135

Тезис

This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.

This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.

NOTE 1        In some countries, national or regional pharmacopoeias or other government regulations are legally binding, and these requirements take precedence over this document.

NOTE 2        Annex E provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of the document.

NOTE 3        Annex F provides recommendations regarding sustainability.

NOTE 4        Annex G provides information on attributive and variable testing.

Общая информация

  •  : Опубликовано
     : 2026-05
    : Опубликование международного стандарта [60.60]
  •  : 4
  • ISO/TC 76
    11.040.20 
  • RSS обновления

Жизненный цикл

Цели в области устойчивого развития

Данный стандарт разработан для достижения следующих Цель устойчивого развития

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