Reference number
ISO 11608-3:2022
International Standard
ISO 11608-3:2022
Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
Edition 3
2022-04
Read sample
ISO 11608-3:2022
76626
Published (Edition 3, 2022)

ISO 11608-3:2022

ISO 11608-3:2022
76626
Language
Format
CHF 151
Convert Swiss francs (CHF) to your currency

Abstract

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.

General information

  •  : Published
     : 2022-04
     : 2023-01
     : 2023-01
    : International Standard published [60.60]
  •  : 3
     : 27
  • ISO/TC 84
    11.040.25 
  • RSS updates

Got a question?

Check out our Help and Support