SS-EN-ISO-11608-3 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022)

SS-EN-ISO-11608-3 - 2022 EDITION - CURRENT
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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 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.

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

11.040.25 (Syringes, needles and catheters)

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Designation Name

SS-EN ISO 11608-3:2022

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Publication Date

May 1, 2022



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International Equivalent

EN ISO 11608-3:2022(IDT); ISO 11608-3:2022(IDT)