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ISO 8536-4:2010

Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed

General information

Withdrawn from 18.09.2019
ICS Groups
11.040.20 Transfusion, infusion and injection equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
17.09.2019
Main
ISO 8536-4:2019
26.02.2013
Amendment
ISO 8536-4:2010/Amd 1:2013
Main
ISO 8536-4:2010
Main
ISO 8536-4:2007
ISO 8536-4:2010 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of ISO 8536-4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-4:2010.

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Standard monitoring
English (PDF 162 KB)

Related products

Main

ISO 8536-4:2019

Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
Newest version Valid from 17.09.2019
Amendment

ISO 8536-4:2010/Amd 1:2013

ISO 8536-4:2010 - Amendment
Withdrawn from 18.09.2019
Main

EVS-EN ISO 80369-1:2018

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018)
Newest version Valid from 03.12.2018
Main

EVS-EN 60601-2-24:2015

Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
Newest version Valid from 08.06.2015

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