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17/30357486 DC : 0

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NA

Status of Standard is Unknown

BS EN ISO 15747 - PLASTIC CONTAINERS FOR INTRAVENOUS INJECTIONS
Available format(s)

Hardcopy , PDF

Language(s)

English

Foreword
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) - Chemical tests
Annex D (normative) - Reference spike
Annex ZA (informative) - Relationship between this
         European Standard and the essential requirements
         of Directive 93/42/EEC [OJ L 169] aimed to be covered
Bibliography

BS EN ISO 15747.

Committee
CH/212
DocumentType
Draft
Pages
23
PublisherName
British Standards Institution
Status
NA

ISO 8536-2:2010 Infusion equipment for medical use — Part 2: Closures for infusion bottles
ISO 15510:2014 Stainless steels Chemical composition
ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

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