In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

22-02-2012

Publisher

Asociacion Espanola de Normalizacion

Committee	CTN 129
DevelopmentNote	Supersedes UNE EN 592. (01/2013)
DocumentType	Standard
Pages	18
PublisherName	Asociacion Espanola de Normalizacion
Status	Current
Supersedes	UNE-EN ISO 18113-5:2010 UNE-EN 592:2002

Standards	Relationship
ISO 18113-5:2009	Identical
EN ISO 18113-5:2011	Identical

IEC 61326-2-6:2012	Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
ISO 18113-1:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
EN 592 : 2002	INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
ISO 18113-4:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
ISO 17593:2007	Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 61010-1:2010+AMD1:2016 CSV	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
ISO 15197:2013	In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
EN 980:2008	Symbols for use in the labelling of medical devices