EN ISO 8536-5:2013
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)
06-02-2013
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
|
| Standards | Relationship |
| ISO 8536-5:2004 | Identical |
| NF EN ISO 8536-5 : 2013 | Identical |
| NBN EN ISO 8536-5 : 2013 | Identical |
| NEN EN ISO 8536-5 : 2013 | Identical |
| NS EN ISO 8536-5 : 2013 | Identical |
| I.S. EN ISO 8536-5:2013 | Identical |
| PN EN ISO 8536-5 : 2013 | Identical |
| SN EN ISO 8536-5:2013 | Identical |
| UNI EN ISO 8536-5 : 2013 | Identical |
| UNE-EN ISO 8536-5:2013 | Identical |
| BS EN ISO 8536-5:2013 | Identical |
| DIN EN ISO 8536-5:2013-10 | Identical |
| ISO 8536-4:2010 | Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed |
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