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EVS-EN ISO 8536-11:2015

Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)

General information

Valid from 02.07.2015
Base Documents
ISO 8536-11:2015; EN ISO 8536-11:2015
ICS Groups
11.040.20 Transfusion, infusion and injection equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.07.2015
Main
EVS-EN ISO 8536-11:2015
09.02.2005
Main
EVS-EN ISO 8536-11:2005
This part of ISO 8536 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

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Standard monitoring
English (PDF 494 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