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
Conformity to regulation : Designated

Format
PDF

Format
HARDCOPY






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
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)ISO 1000, EN 980, IEC 62366, ISO 13485, ISO 15223-1, ISO 14971
Informative References(Provided for Information)ISO 3534-1:2006, ISO 1087-1:2000, ISO/IEC Guide 51:1999, ISO 17593:2007, ISO 15198:2004, ISO 25680, ISO 17511:2003, IEC 60601-1-6:2006, IEC 60050, ISO/IEC 17025, ISO/IEC 80416-1:2001, ISO 3534-2:2006, CLSI EP6-A, ISO Guide 30:1992, CLSI C51-P, ISO 10241, CLSI EP17-A, CLSI EP9-A2, CLSI EP12-A2, IEC 60050-300:2001, ISO 704:2000, ISO/IEC Guide 98-3:2008, ISO 15190:2003, VIM:1993, ISO 8601, EN 591:2001, ISO 15194, CLSI EP5-A2, ISO 15189:2007, CLSI GP10-A, 98/79/EC, CLSI EP7-A2, IEC 61010-2-101:2002, BS ISO 5725-2:2019, ISO/IEC Guide 99:2007, ISO 5725-2:2019, EN 375:2001, EN 13612:2002, EN 592:2002, ISO 5725-5:1998, EN 376:2002, ISO 5725-3:1994, EN 13640:2002, ISO 5725-1:1994, CLSI X5-R, ISO 15193:2002, ISO/IEC 80000, ISO 9000:2005, IEC 60359, CLSI C28-A2:2000, ISO 15197:2003, GUM:1995, ISO 18153
ReplacesBS EN ISO 18113-1:2009
International RelationshipsEN ISO 18113-1:2011,ISO 18113-1:2009
Amended ByCorrigendum, January 2012
DescriptorsProduct information, Clinical laboratory equipment, Reagent solutions, Definitions, Measurement, Labelling (process), Instructions for use, Clinical investigation instruments, Diagnostic reagents, Labels, Diagnosis (medical), Medical equipment
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 Size2.057 MB
Price£260.00


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