Skip to main content
Tagasi

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)

Üldinfo

Kehtiv alates 17.05.2022
Alusdokumendid
ISO 11608-3:2022; EN ISO 11608-3:2022
Direktiivid või määrused
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.

Nõutud väljad on tähistatud *

*
*
*
PDF
24,40 € koos KM-ga
PDF redline
31,72 € koos KM-ga
Paber
24,40 € koos KM-ga
Sirvi standardit alates 2,44 € koos KM-ga
Standardi monitooring

Teised on ostnud veel

Põhitekst

EVS-EN ISO 11608-1:2022

Nõelinfusiooni süsteemid meditsiiniliseks kasutamiseks. Nõuded ja katsemeetodid. Osa 1: Nõelinfusiooni süsteemid
Uusim versioon Kehtiv alates 17.05.2022
Põhitekst + muudatus

EVS-EN ISO 14971:2019+A11:2021

Meditsiiniseadmed. Riskihalduse rakendamine meditsiiniseadmetele
Uusim versioon Kehtiv alates 15.12.2021
Põhitekst

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
Põhitekst

EVS-EN ISO 11608-5:2023

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
Uusim versioon Kehtiv alates 03.04.2023