Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment
|Publication Date:||1 July 2015|
|ICS Code (Transfusion, infusion and injection equipment):||11.040.20|
NEN-EN-ISO 8536-11 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.