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NF EN ISO 8536-11 : 2015

Current

Current

The latest, up-to-date edition.

INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT

Published date

12-01-2013

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1 Scope
2 Normative references
3 Designation
4 Design
5 Materials
6 Physical requirements
   6.1 Transparency
   6.2 Particulate contamination
   6.3 Tensile strength
   6.4 Leakage
   6.5 Adapters with female and/or male conical fittings
   6.6 Protective caps
7 Chemical requirements
8 Biological requirements
   8.1 Sterility
   8.2 Pyrogens
   8.3 Haemolysis
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

DevelopmentNote
Indice de classement: S93-123-11. PR NF EN ISO 8536-11 February 2003. (02/2003) PR NF EN ISO 8536-11 November 2013. (12/2013)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Current

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