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BS EN ISO 8536-13:2016

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Infusion equipment for medical use Graduated flow regulators for single use with fluid contact

Superseded date

04-10-2024

Superseded by

BS EN ISO 8536-13:2024

Published date

31-10-2016

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Committee
CH/212
DevelopmentNote
Supersedes 15/30283697 DC. (10/2016)
DocumentType
Standard
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

This part of ISO8536 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 ISO8536.

Standards Relationship
EN ISO 8536-13:2016 Identical
ISO 8536-13:2016 Identical

ISO 80000-4:2006 Quantities and units Part 4: Mechanics
ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN ISO 80000-4:2013 Quantities and units - Part 4: Mechanics (ISO 80000-4:2006)

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