I.S. EN ISO 8536-8:2015
Current
The latest, up-to-date edition.
INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015)
Hardcopy , PDF
English
01-01-2015
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 Terms and definitions
4 General requirements
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
9 Packaging
10 Labelling
11 Disposal
Annex A (normative) - Physical tests
Annex B (normative) - Storage volume
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EC Directive 93/42/EEC on medical devices
Bibliography
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