ISO 11608-3:2022
Current
The latest, up-to-date edition.
Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
French, English
07-04-2022
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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 ISO11608-1.
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 ISO11040-8) 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.
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 11608-3:2022 | Identical |
| I.S. EN ISO 11608-3:2022 | Identical |
| UNI EN ISO 11608-3:2022 | Identical |
| ÖNORM EN ISO 11608-3:2022 10 15 | Identical |
| PN-EN ISO 11608-3:2022-11 | Identical |
| NS-EN ISO 11608-3:2022 | Identical |
| ÖNORM EN ISO 11608-3:2024 01 01 | Identical |
| BS EN ISO 11608-3:2022 | Identical |
| UNE-EN ISO 11608-3:2022 | Identical |
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