ISO 8536-11:2015
Infusion equipment for medical use — Part 11: Infusion filters for single use with pressure infusion equipment
ISO 8536-11:2015 applies 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. It does not include the effectiveness of filters for separation of particles or germs.
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Foreword
1 Scope
2 Normative references
3 Design
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 Protective caps
6 Chemical requirements
7 Biological requirements
7.1 Sterility
7.2 Pyrogens
7.3 Haemolysis
8 Packaging
9 Labelling
9.1 General
9.2 Label on unit container
9.3 Label on shelf or multi-unit container
10 Disposal
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography
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Foreword
1 Scope
2 Normative references
3 Design
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 Protective caps
6 Chemical requirements
7 Biological requirements
7.1 Sterility
7.2 Pyrogens
7.3 Haemolysis
8 Packaging
9 Labelling
9.1 General
9.2 Label on unit container
9.3 Label on shelf or multi-unit container
10 Disposal
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography