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CEN
EN ISO 15747:2011

EN ISO 15747:2011

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Plastic containers for intravenous injections (ISO 15747:2010)

Superseded date

13-03-2019

Superseded by

EN ISO 15747:2019

Published date

19-10-2011

Publisher

Comite Europeen de Normalisation

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Identification
6 Application of tests
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Biological tests
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on medical devices

ISO 15747:2010 contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.ISO 15747:2010 is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.

Committee
CEN/BT
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
BS EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features
I.S. EN ISO 3826-4:2015 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features

ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed

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