NF EN ISO 8536-13
Infusion equipment for medical use - Part 13 : graduated flow regulators for single use with fluid contact
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.
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.
-
1 Domaine d'application
-
2 Références normatives
-
3 Termes et définitions
-
4 Conception
-
5 Matériaux
-
6 Exigences physiques
-
7 Exigences chimiques
-
8 Exigences biologiques
- Annexe A Essais physiques
- Bibliographie
COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.
Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!
Request your free, no-obligation live demo
I discover COBAZ