Name: EN ISO 8536-13:2016
Brand: CEN

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

Published date

10-19-2016

Publisher

Comite Europeen de Normalisation

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Design
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
Annex A (normative) - Physical tests
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of Directive 93/42/EEC [OJ L 169]
         aimed to be covered

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.

Committee	CEN/TC 205
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

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