Back

ISO 11608-4:2006

Pen-injectors for medical use -- Part 4: Requirements and test methods for electronic and electromechanical pen-injectors

General information

Withdrawn from 07.04.2022
ICS Groups
11.040.25 Syringes, needles and catheters
Directives or regulations
None

Standard history

Status
Date
Type
Name
07.04.2022
Main
ISO 11608-4:2022
17.03.2006
Main
ISO 11608-4:2006
ISO 11608-4:2006 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. The injector may be for single-use or multiple-use. The injector system is intended to deliver medication to an end-user by self-administration or with assistance.

Required fields are indicated with *

*
*
*
PDF
79.98 € incl tax
Paper
79.98 € incl tax
Standard monitoring
English (PDF 166 KB)

Related products

Main

ISO 11608-4:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
Newest version Valid from 07.04.2022
Main

EVS-EN ISO 80369-7:2021

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)
Newest version Valid from 01.06.2021
Main

EVS-EN ISO 10555-1:2013

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013)
Withdrawn from 15.12.2023
Amendment

EVS-EN ISO 10555-1:2013/A1:2017

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements - Amendment 1 (ISO 10555-1:2013/Amd 1:2017)
Withdrawn from 15.12.2023

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