I.S. EN ISO 15747:2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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)
Hardcopy , PDF
04-04-2019
English
01-01-2011
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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.
DocumentType |
Standard
|
Pages |
29
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
EN ISO 15747:2011 | Identical |
ISO 15747:2010 | Identical |
ISO 8536-4:2010 | Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed |
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