15/30283697 DC : 0
Superseded
View Superseded by
BS EN ISO 8536-13 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 13: GRADUATED FLOW REGULATORS FOR SINGLE USE WITH FLUID CONTACT
Hardcopy , PDF
English
10-31-2016
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Design
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
9 Packaging
10 Labelling
Annex A (normative) - Physical tests
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on Medical Devices
Bibliography
BS EN ISO 8536-13.
| Committee |
CH/212
|
| DocumentType |
Draft
|
| Pages |
14
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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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