BS EN ISO 18113-1:2011 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements

BS EN ISO 18113-1:2011

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

Status : Current   Published : October 2011

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Standard NumberBS EN ISO 18113-1:2011
TitleIn vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements
StatusCurrent
Publication Date31 October 2011
Normative References(Required to achieve compliance to this standard)ISO 1000, ISO 13485, ISO 14971, ISO 15223-1, IEC 62366, EN 980
Informative References(Provided for Information)ISO 704:2000, ISO 1087-1:2000, ISO 3534-1:2006, ISO 3534-2:2006, ISO 5725-1:1994, ISO 5725-3:1994, ISO 8601, ISO 10241, ISO 15189:2007, ISO 15190:2003, ISO 15193:2002, ISO 15194, ISO 15197:2003, ISO 15198:2004, ISO/IEC 17025, ISO 17511:2003, ISO 17593:2007, ISO 18153, ISO 25680, IEC 60050, IEC 60601-1-6:2006, IEC 61010-2-101:2002, ISO/IEC 80000, ISO/IEC 80416-1:2001, ISO Guide 30:1992, ISO/IEC Guide 51:1999, ISO/IEC Guide 98-3:2008, GUM:1995, ISO/IEC Guide 99:2007, EN 375:2001, EN 376:2002, EN 591:2001, EN 592:2002, EN 13612:2002, EN 13640:2002, CLSI C28-A2:2000, CLSI EP9-A2, CLSI X5-R, CLSI EP12-A2, CLSI EP5-A2, CLSI C51-P, CLSI EP7-A2, CLSI EP17-A, CLSI EP6-A, CLSI GP10-A, ISO 5725-2, ISO 5725-5:1998, ISO 9000:2005, IEC 60050-300:2001, VIM:1993, IEC 60359, 98/79/EC
ReplacesBS EN ISO 18113-1:2009
International RelationshipsEN ISO 18113-1:2011,ISO 18113-1:2009
Amended ByCorrigendum, January 2012
DescriptorsDiagnosis (medical), Medical equipment, Product information, Instructions for use, Labels, Labelling (process), Clinical investigation instruments, Diagnostic reagents, Clinical laboratory equipment, Reagent solutions, Definitions, Measurement
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 77327 3
PublisherBSI
FormatA4
DeliveryYes
Pages62
File Size2.083 MB
Price£254.00


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