Abstract

This document 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 document.

Begin

2022-05-11

WI

00205387

Planned document number

DIN EN ISO 8536-13

Project number

06302159

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  

Responsible international committee

ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment  

draft standard

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO/DIS 8536-13:2023); German and English version prEN ISO 8536-13:2023
2023-09
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previous edition(s)

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016); German version EN ISO 8536-13:2016
2017-01

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