NEN EN ISO 8536-10 : 2015
Current
The latest, up-to-date edition.
INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT
12-01-2013
1 Scope
2 Normative references
3 Designation
4 Materials
5 Physical requirements
5.1 Avoidance of air bubbles
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
5.7 Manipulation of stopcocks
5.8 Unit with injection site
5.9 Unit with check valve
6 Chemical requirements
7 Biological requirements
7.1 Sterility
7.2 Pyrogens
7.3 Haemolysis
8 Packaging
9 Labelling
9.1 Unit container
9.2 Shelf or multi-unit container
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography
Pertains to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Standards | Relationship |
| UNE-EN ISO 8536-10:2015 | Identical |
| EN ISO 8536-10:2015 | Identical |
| ISO 8536-10:2015 | Identical |
| DIN EN ISO 8536-10:2015-11 | Identical |
| I.S. EN ISO 8536-10:2015 | Identical |
| BS EN ISO 8536-10:2015 | Identical |