BS EN ISO 13485:2001 - Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001

BS EN ISO 13485:2001

Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001

Status : Revised, Withdrawn   Published : March 2001 Replaced By : BS EN ISO 13485:2003

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Standard NumberBS EN ISO 13485:2001
TitleQuality systems. Medical devices. Particular requirements for the application of EN ISO 9001
StatusRevised, Withdrawn
Publication Date15 March 2001
Withdrawn Date01 July 2006
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS EN ISO 13485:2003
ReplacesBS EN 46001:1997
International RelationshipsEN ISO 13485:2000,ISO 13485:1996
DescriptorsMedical equipment, Medical instruments, Quality assurance systems, Quality assurance, Quality, Design, Installation, Maintenance, Production management
ICS03.120.10
11.040.01
Title in FrenchSystemes qualite. Dispositifs medicaux. Exigences particulieres relatives a l'application de l'EN ISO 9001
Title in GermanQualitaetssicherungssysteme. Medizinprodukte. Besondere Anforderngen fuer die Anwendung von EN ISO 9001
CommitteeCH/210/1
ISBN0 580 36992 7
PublisherBSI
FormatA4
DeliveryNo
Pages20
File Size1.275 MB
Price£130.00


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