Overview

This part of ISO 8536 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. This standard does not deal with the effectiveness of filters for separation of particles or germs. The European Standard has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use"(secretariat: DIN, Germany) in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN, Germany) with the participation of German experts. The responsible German standardization committee is Working Committee NA 063-02-02 AA "Transfusions-/Infusionsbehältnisse und -geräte aus Kunststoffen" ("Transfusion/infusion containers and equipment made from plastics") of the DIN Standards Committee Medicine (NAMed).

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-04-03 AA - Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics  

Responsible european committee

CEN/TC 205 - Non-active medical devices