NEN EN ISO 8536-9 : 2015
Current
The latest, up-to-date edition.
INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT
12-01-2013
1 Scope
2 Normative references
3 Designation
4 Materials
5 Physical requirements
5.1 Transparency
5.2 Particulate contamination
5.3 Tensile strength
5.4 Leakage
5.5 Adapters with female and/or male conical fittings
5.6 Accessories
5.7 Filters
5.8 Storage volume
5.9 Injection needles
5.10 Protective caps
6 Chemical requirements
7 Biological requirements
7.1 Sterility
7.2 Pyrogens
7.3 Haemolysis
8 Packaging
9 Labelling
9.1 Unit container
9.2 Shelf or multi-unit container
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography
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