60.60 Standard published Feb 7, 2018
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.20 Transfusion, infusion and injection equipment
Published
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.
Legislation related to this standard
PUBLISHED
EN ISO 8536-14:2018
60.60
Standard published
Feb 7, 2018
