BS EN ISO 11608-3:2022
Current
The latest, up-to-date edition.
Needle-based injection systems for medical use. Requirements and test methods Containers and integrated fluid paths
Hardcopy , PDF
English
13-11-2023
| Committee |
CH/84
|
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| Standards | Relationship |
| I.S. EN ISO 11608-3:2022 | Equivalent |
| DIN EN ISO 11608-3:2022-09 | Equivalent |
| ISO 11608-3:2022 | Identical |
| EN ISO 11608-3:2022 | Identical |
| UNE-EN ISO 11608-3:2022 | Equivalent |
| EN ISO 11608-3:2022 | Equivalent |
| ISO 11608-3:2022 | Equivalent |
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