EN ISO 8536-14:2018
Current
The latest, up-to-date edition.
Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)
07-02-2018
European foreword
Annex ZA (informative) - Relationship between this European
standard and the essential requirements
of Directive 93/42/EEC [OJ L 169] aimed to
be covered
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Design
5 Materials
6 Physical requirements
Annex A (normative) - Physical tests
Bibliography
ISO 8536-14:2016 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.
| Committee |
CEN/TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN ISO 8536-14:2018 | Identical |
| NF EN ISO 8536-14 : 2018 | Identical |
| ISO 8536-14:2016 | Identical |
| SS-EN ISO 8536-14:2018 | Identical |
| NS EN ISO 8536-14 : 2018 | Identical |
| NEN EN ISO 8536-14 : 2018 | Identical |
| SN EN ISO 8536-14:2018 | Identical |
| I.S. EN ISO 8536-14:2018 | Identical |
| ONORM EN ISO 8536-14 : 2018 | Identical |
| DIN EN ISO 8536-14 E : 2018 | Identical |
| UNE-EN ISO 8536-14:2018 | Identical |
| DIN EN ISO 8536-14:2015-08 (Draft) | Identical |
| DIN EN ISO 8536-14:2018-04 | Identical |
| PN-EN ISO 8536-14:2018 | Identical |
| BS EN ISO 8536-14:2018 | Identical |
| 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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