Abstract
PreviewThis 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.
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Status: PublishedPublication date: 2022-04
Corrected version (en): 2023-01
Corrected version (fr): 2023-01 -
Edition: 3Number of pages: 27
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- ICS :
- 11.040.25 Syringes, needles and catheters
Buy this standard
| Format | Language | |
|---|---|---|
| std 1 145 | PDF + ePub | |
| std 2 145 | Paper |
- CHF145
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