ISO 8536-10:2015
Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment
ISO 8536-10:2015 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.
ISO 8536-10:2015 includes the following:
a) two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold;
b) units with injection site or check valve;
c) stoppers or adapters.
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Foreword
1 Scope
2 Normative references
3 Materials
4 Physical requirements
4.1 Avoidance of air bubbles
4.2 Particulate contamination
4.3 Tensile strength
4.4 Leakage
4.5 Adapters with female and/or male conical fittings
4.6 Protective caps
4.7 Manipulation of stopcocks
4.8 Unit with injection site
4.9 Unit with check valve
5 Chemical requirements
6 Biological requirements
6.1 Sterility
6.2 Pyrogens
6.3 Haemolysis
7 Packaging
8 Labelling
8.1 General
8.2 Label on unit container
8.3 Label on shelf or multi-unit container
9 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 Materials
4 Physical requirements
4.1 Avoidance of air bubbles
4.2 Particulate contamination
4.3 Tensile strength
4.4 Leakage
4.5 Adapters with female and/or male conical fittings
4.6 Protective caps
4.7 Manipulation of stopcocks
4.8 Unit with injection site
4.9 Unit with check valve
5 Chemical requirements
6 Biological requirements
6.1 Sterility
6.2 Pyrogens
6.3 Haemolysis
7 Packaging
8 Labelling
8.1 General
8.2 Label on unit container
8.3 Label on shelf or multi-unit container
9 Disposal
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography