I.S. EN ISO 8536-13:2016
Current
The latest, up-to-date edition.
INFUSION EQUIPMENT FOR MEDICAL USE - PART 13: GRADUATED FLOW REGULATORS FOR SINGLE USE WITH FLUID CONTACT (ISO 8536-13:2016)
Hardcopy , PDF
English
01-01-2016
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.
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European foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Design
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
Annex A (normative) - Physical tests
Bibliography
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of Directive 93/42/EEC [OJ L 169]
aimed to be covered
Gives requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 8536-13:2016 | Identical |
| ISO 8536-13:2016 | Identical |
| ISO 80000-4:2006 | Quantities and units Part 4: Mechanics |
| 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 |
| EN ISO 80000-4:2013 | Quantities and units - Part 4: Mechanics (ISO 80000-4:2006) |
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