BS EN 46001:1997 - Specification for application of EN ISO 9001 to the manufacture of medical devices

BS EN 46001:1997

Specification for application of EN ISO 9001 to the manufacture of medical devices

Status : Superseded, Withdrawn   Published : February 1997 Replaced By : BS EN ISO 13485:2001

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Standard NumberBS EN 46001:1997
TitleSpecification for application of EN ISO 9001 to the manufacture of medical devices
StatusSuperseded, Withdrawn
Publication Date15 February 1997
Withdrawn Date01 February 2004
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 13485:2001
ReplacesBS EN 46001:1994
International RelationshipsEN 46001:1996
Draft Superseded By90/56565 DC
DescriptorsQuality assurance systems, Medical instruments, Medical equipment, Quality assurance, Quality control, Production management
ICS03.120.10
11.040.01
Title in FrenchSystèmes qualité. Dispositifs médicaux. Exigences particulières relatives à l'application de l'EN ISO 9001
Title in GermanQualitaetssicherungssysteme. Medizinprodukte. Besondere Anforderungen fuer die Anwendung von EN ISO 9001
CommitteeCH/210/1
ISBN0 580 27045 9
PublisherBSI
FormatA4
DeliveryNo
Pages14
File Size153 KB
Price£130.00


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