I.S. 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)
Hardcopy , PDF
English
01-01-2013
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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.
DocumentType |
Standard
|
Pages |
19
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Current
|
Supersedes |
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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