DIN EN ISO 8536-13:2017-01

This part of ISO 8536 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 this part of ISO 8536. This document has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing 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 national standardization committee is Working Committee NA 063-02-02 AA "Transfusions-/Infusionsbehältnisse und geräte aus Kunststoffen und Einmalprobengefäße für die In-vitro-Diagnostik" ("Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics") at DIN Standards Committee Medicine (NAMed).