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SNV - SN EN ISO 11608-3

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths

active, Most Current
Organization: SNV
Publication Date: 1 May 2022
Status: active
Page Count: 38
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

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.

Document History

SN EN ISO 11608-3
May 1, 2022
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
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...
December 1, 2012
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
This part of ISO 11608 specifies the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is...

References

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