NEN EN ISO 8536-4 : 2013
Current
The latest, up-to-date edition.
INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
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 Leakage
6.3 Tensile strength
6.4 Closure-piercing device
6.5 Air-inlet device
6.6 Tubing
6.7 Fluid filter
6.8 Drip chamber and drip tube
6.9 Flow regulator
6.10 Flow rate of infusion fluid
6.11 Injection site
6.12 Male conical fitting
6.13 Protective caps
7 Chemical requirements
7.1 Reducing (oxidizable) matter
7.2 Metal ions
7.3 Titration acidity or alkalinity
7.4 Residue on evaporation
7.5 UV absorption of extract solution
8 Biological requirements
8.1 General
8.2 Sterility
8.3 Pyrogenicity
8.4 Haemolysis
8.5 Toxicity
9 Labelling
9.1 Unit container
9.2 Shelf or multi-unit container
10 Packaging
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography
Defines requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
| DevelopmentNote |
Supersedes NEN ISO 8536-4. (09/2004)
|
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| BS EN ISO 8536-4 : 2013 | Identical |
| DIN EN ISO 8536-4:2013-07 | Identical |
| UNI EN ISO 8536-4 : 2013 | Identical |
| ISO 8536-4:2010 | Identical |
| UNE-EN ISO 8536-4:2013 | Identical |
| I.S. EN ISO 8536-4:2013 | Identical |
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