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BS EN ISO 8536-13:2016

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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

Withdrawn date

08-23-2023

Published date

10-31-2016

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.

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Withdrawn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

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

ISO 80000-4:2006 Quantities and units Part 4: Mechanics
EN ISO 8536-4:2013/A1:2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013)
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 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
EN ISO 80000-4:2013 Quantities and units - Part 4: Mechanics (ISO 80000-4:2006)

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