ISO 8536-8:2015
Infusion equipment for medical use — Part 8: Infusion sets for single use with pressure infusion apparatus
ISO 8536-8:2015 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar).
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials
6 Physical requirements
6.1 Particulate contamination
6.2 Tensile strength
6.3 Leakage
6.4 Male conical fitting
6.5 Injection site
6.6 Fluid filter
6.7 Flow rate of infusion fluid
6.8 Closure-piercing device
6.9 Air-inlet device
6.10 Drip chamber and drip tube
6.11 Tubing
6.12 Flow regulator
6.13 Protective caps
6.14 Storage volume
7 Chemical requirements
8 Biological requirements
9 Packaging
10 Labelling
10.1 General
10.2 Label on unit container
10.3 Label on shelf or multi-unit container
11 Disposal
Annex A (normative) Physical tests
Annex B (normative) Storage volume
Bibliography
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials
6 Physical requirements
6.1 Particulate contamination
6.2 Tensile strength
6.3 Leakage
6.4 Male conical fitting
6.5 Injection site
6.6 Fluid filter
6.7 Flow rate of infusion fluid
6.8 Closure-piercing device
6.9 Air-inlet device
6.10 Drip chamber and drip tube
6.11 Tubing
6.12 Flow regulator
6.13 Protective caps
6.14 Storage volume
7 Chemical requirements
8 Biological requirements
9 Packaging
10 Labelling
10.1 General
10.2 Label on unit container
10.3 Label on shelf or multi-unit container
11 Disposal
Annex A (normative) Physical tests
Annex B (normative) Storage volume
Bibliography