BS EN ISO 18113-1:2009 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements

BS EN ISO 18113-1:2009

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements

Status : Revised, Withdrawn   Published : February 2010 Replaced By : BS EN ISO 18113-1:2011

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Standard NumberBS EN ISO 18113-1:2009
TitleIn vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements
StatusRevised, Withdrawn
Publication Date28 February 2010
Confirm Date05 August 2015
Withdrawn Date31 October 2011
Normative References(Required to achieve compliance to this standard)ISO 1000, IEC 62366, EN 980, ISO 14971, ISO 15223-1, ISO 13485
Informative References(Provided for Information)ISO 1087-1:2000, ISO 10241, VIM:1993, CLSI EP6-A, ISO 17593:2007, ISO 18153, ISO 15190:2003, IEC 60050, CLSI X5-R, ISO 17511:2003, ISO 3534-1:2006, ISO 25680, ISO 15194, CLSI C51-P, CLSI C28-AMD 2:2000, ISO 15197:2003, CLSI EP5-AMD 2, CLSI EP7-AMD 2, ISO/IEC Guide 51:1999, EN 591:2001, ISO Guide 30:1992, ISO/IEC 80416-1:2001, CLSI EP12-AMD 2, CLSI EP9-AMD 2, ISO/IEC 17025, GUM:1995, ISO 9000:2005, 98/79/EC, ISO/IEC Guide 98-3:2008, IEC 60050-300:2001, ISO 15198:2004, IEC 60359, ISO 5725-1:1994, EN 375:2001, EN 13612:2002, BS ISO 5725-2:2019, ISO 5725-2:2019, ISO 5725-5:1998, EN 13640:2002, ISO 5725-3:1994, ISO/IEC Guide 99:2007, EN 592:2002, EN 376:2002, IEC 61010-2-101:2002, CLSI GP10-A, ISO 8601, ISO 15189:2007, ISO 3534-2:2006, ISO/IEC 80000, CLSI EP17-A, ISO 15193:2002, IEC 60601-1-6:2006, ISO 704:2000
Replaced ByBS EN ISO 18113-1:2011
International RelationshipsISO 18113-1:2009,EN ISO 18113-1:2009
Draft Superseded By06/30146511 DC
DescriptorsLabelling (process), Reagent solutions, Diagnosis (medical), Instructions for use, Clinical laboratory equipment, Clinical investigation instruments, Measurement, Labels, Medical equipment, Product information, Diagnostic reagents, Definitions
ICS11.100.10
Title in FrenchDispositifs médicaux de diagnostic in vitro. Informations fournies par le fabricant (étiquetage). Termes, définitions et exigences générales
Title in GermanIn-vitro-Diagnostika. Bereitstellung von Informationen durch den Hersteller. Begriffe und allgemeine Anforderungen
CommitteeCH/212
ISBN978 0 580 56589 2
PublisherBSI
FormatA4
DeliveryNo
Pages60
File Size734 KB
Price£254.00


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