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CEN
EN ISO 8536-5:2013

EN ISO 8536-5:2013

Current

Current

The latest, up-to-date edition.

Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)

Published date

02-06-2013

Publisher

Comite Europeen de Normalisation

Foreword
1 Scope
2 Normative references
3 General requirements
4 Designation
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
9 Labelling
10 Packaging
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EC Directive 93/42/EEC on
         Medical Devices

ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment. ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials. In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.

Committee
CEN/TC 205
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed

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