NEN EN ISO 8536-11 : 2015
Current
The latest, up-to-date edition.
INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT
01-12-2013
1 Scope
2 Normative references
3 Designation
4 Design
5 Materials
6 Physical requirements
6.1 Transparency
6.2 Particulate contamination
6.3 Tensile strength
6.4 Leakage
6.5 Adapters with female and/or male conical fittings
6.6 Protective caps
7 Chemical requirements
8 Biological requirements
8.1 Sterility
8.2 Pyrogens
8.3 Haemolysis
9 Packaging
10 Labelling
10.1 Unit container
10.2 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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