BS EN ISO 11608-3:2022
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Needle-based injection systems for medical use. Requirements and test methods Containers and integrated fluid paths
Hardcopy , PDF
13-11-2023
English
13-11-2023
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/84
|
| DocumentType |
Standard
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| Pages |
36
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| PublisherName |
British Standards Institution
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| Status |
Withdrawn
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| 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 |
| ISO 11608-3:2022 | Identical |
| EN ISO 11608-3:2022 | Identical |
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