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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)

General information

Valid from 03.04.2023
Base Documents
ISO 11608-5:2022; EN ISO 11608-5:2023
ICS Groups
11.040.25 Syringes, needles and catheters
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.04.2023
Main
EVS-EN ISO 11608-5:2023
06.11.2012
Main
EVS-EN ISO 11608-5:2012
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.

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Standard monitoring
English (PDF 634 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English