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EVS-EN ISO 11608-3:2022

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

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Kehtiv alates 17.05.2022
Alusdokumendid
ISO 11608-3:2022; EN ISO 11608-3:2022
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puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
17.05.2022
Põhitekst
06.11.2012
Põhitekst
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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EVS-EN ISO 11608-1:2022

Nõelinfusiooni süsteemid meditsiiniliseks kasutamiseks. Nõuded ja katsemeetodid. Osa 1: Nõelinfusiooni süsteemid
Uusim versioon Kehtiv alates 17.05.2022
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EVS-EN ISO 11608-2:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)
Uusim versioon Kehtiv alates 17.05.2022
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EVS-EN ISO 11608-4:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
Uusim versioon Kehtiv alates 17.05.2022