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Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO/DIS 8536-13:2023)

Abstract

ISO 8536-13:2016 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 ISO 8536-13:2016.

Begin

2022-05-02

WI

00205387

Planned document number

prEN ISO 8536-13

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  

previous edition(s)

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
2016-10

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Contact

Dipl.-Ing.

Bernd Bösler

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2488
Fax: +49 30 2601-42488

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