BS EN ISO 8536-5:2013
Current
The latest, up-to-date edition.
Infusion equipment for medical use Burette infusion sets for single use, gravity feed
Hardcopy , PDF
English
28-02-2013
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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
Describes 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.
| Committee |
CH/205
|
| DevelopmentNote |
Renumbers and supersedes BS ISO 8536-5. 2011 version incorporates corrigendum to BS ISO 8536-5. Supersedes 00/560446 DC. (12/2011) Reviewed and confirmed by BSI, May 2018. (05/2018)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This part of ISO8536 specifies requirements for types of single-use, gravity feed burette infusion sets of 50ml, 100ml and 150ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment.
This part of ISO8536 also provides guidance on specifications relating to the quality and performance of materials used in infusion sets.
NOTE In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO8536.
| Standards | Relationship |
| EN ISO 8536-5:2013 | Identical |
| ISO 8536-5:2004 | Identical |
| ISO 8536-4:2010 | Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed |
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