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BS 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Plastic containers for intravenous injections
Available format(s)

Hardcopy , PDF

Superseded date

03-23-2019

Language(s)

English

Published date

11-30-2011

Publisher

British Standards Institution

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

Includes requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.

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
CH/212
DevelopmentNote
Issue Date: 31/07/2009. Supersedes 01/563307 DC. (08/2009) Supersedes 08/30181526 DC. (05/2010)
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 15747:2010 Identical
EN ISO 15747:2011 Identical

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

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Hardcopy - English
PDF - English
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