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
12-01-2013
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
Pertains to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 8536-11:2015 | Identical |
| UNI EN ISO 8536-11 : 2005 | Identical |
| SN EN ISO 8536-11:2015 | Identical |
| UNE-EN ISO 8536-11:2015 | Identical |
| DIN EN ISO 8536-11:2015-11 | Identical |
| ISO 8536-11:2015 | Identical |
| BS EN ISO 8536-11:2015 | Identical |
| I.S. EN ISO 8536-11:2015 | Identical |
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