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ISO 11608-3:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths

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Kehtiv alates 07.04.2022
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07.04.2022
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20.09.2012
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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.
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ISO 11608-5:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
Uusim versioon Kehtiv alates 07.04.2022
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ISO 11608-2:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles
Uusim versioon Kehtiv alates 07.04.2022
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ISO 11608-1:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
Uusim versioon Kehtiv alates 07.04.2022
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ISO 11040-5:2012

Prefilled syringes -- Part 5: Plunger stoppers for injectables
Uusim versioon Kehtiv alates 20.01.2012