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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)

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Kehtiv alates 17.05.2022
Alusdokumendid
ISO 11608-2:2022; EN ISO 11608-2:2022
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puuduvad
Standardi ajalugu
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Kuupäev
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Nimetus
17.05.2022
Põhitekst
03.05.2012
Põhitekst
This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1. This document is not applicable to the following: —    needles for dental use; —    pre-attached syringe needles; —    hypodermic needles; —    needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular); —    materials that form the medicinal product contact surfaces of the primary container closure. However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them. NOTE       Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608‑3, and hypodermic needles provided separately are covered in ISO 7864.
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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)
Uusim versioon Kehtiv alates 17.05.2022
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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 11608-4:2022

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