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This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.

It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.

This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).

This document is not applicable to the following products:

—    sterile hypodermic needles;

—    sterile hypodermic syringes;

—    sterile single-use syringes, with or without needle, for insulin;

—    containers that can be refilled multiple times;

—    containers intended for dental use;

—    catheters or infusion sets that are attached or assembled separately by the user.


Общая информация 

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2022-04
    Исправленный вариант (английский)
     : 2023-01
    Исправленный вариант (Французский)
     : 2023-01
  • Версия
     : 3
  • Технический комитет
     : ISO/TC 84 Devices for administration of medicinal products and catheters
  • ICS
     :
    11.040.25 Syringes, needles and catheters

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  2. Интернет-магазин
  3. Каталог стандартов
  4. МКС
  5. 11
  6. 11.040
  7. 11.040.25
  8. ISO 11608-3:2022