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ILNAS-EN ISO 8536-13:2016
Edition
10/2016
Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
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Abstract
ISO 8536-13:2016 specifies 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.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-13:2016.
Status
| Standard - Active |
Origin
| Technical Committee : |
| CEN/TC 205 : Non-active medical devices |
Implementation
| start of the vote on the project | 25/06/2015 | date of ratification (dor) | 17/09/2016 | |||
| end of the vote on the project | 25/09/2015 | date of anouncement (doa) | 31/01/2017 | |||
| start of the vote on the final project | 23/06/2016 | date of publication (dop) | 30/04/2017 | |||
| end of the vote on the final project | 16/08/2016 | date of withdrawal (dow) | 30/04/2017 |
|
Publication Official Journal
of the Grand-Duchy of Luxembourg |
18/11/2016 |
| Reference | Mémorial A N° 230 |
Relations
| Evolutions |
| Relations to international standards |
| ISO 8536-13 |
| ISO 8536-13:2016 |
International Classification for Standards (ICS codes) :
| 11.040.20 : Transfusion, infusion and injection equipment |
