NEN EN ISO 8536-8 : 2015
Current
The latest, up-to-date edition.
INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS
12-01-2013
Foreword
1 Scope
2 Normative references
3 General requirements
4 Designation
4.1 Infusion set
4.2 Air-inlet device
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 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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