Infusion equipment for medical use Part 13: Graduated flow regulators for single use with fluid contact

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

09-27-2016

Publisher

International Organization for Standardization

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.

DevelopmentNote	Supersedes ISO/DIS 8536-13. (09/2016)
DocumentType	Standard
Pages	6
PublisherName	International Organization for Standardization
Status	Current

Standards	Relationship
DIN EN ISO 8536-13 E : 2017	Identical
NF EN ISO 8536-13 : 2016	Identical
NEN EN ISO 8536-13 : 2016	Identical
NS EN ISO 8536-13 : 2016	Identical
I.S. EN ISO 8536-13:2016	Identical
PN EN ISO 8536-13 : 2017	Identical
SN EN ISO 8536-13:2016	Identical
UNI EN ISO 8536-13 : 2017	Identical
UNE-EN ISO 8536-13:2017	Identical
BS EN ISO 8536-13:2016	Identical
EN ISO 8536-13:2016	Identical
DIN EN ISO 8536-13:2015-08 (Draft)	Identical
DIN EN ISO 8536-13:2017-01	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)