BS EN 46002:1997 - Specification for application of EN ISO 9002 to the manufacture of medical devices

BS EN 46002:1997

Specification for application of EN ISO 9002 to the manufacture of medical devices

Status : Superseded, Withdrawn   Published : February 1997 Replaced By : BS EN ISO 13488:2001

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Specifies additional requirements for quality systems used in manufacture of medical devices.




Standard NumberBS EN 46002:1997
TitleSpecification for application of EN ISO 9002 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StatusSuperseded, Withdrawn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Withdrawn Date01 February 2004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 13488:2001
ReplacesBS EN 46002:1994
International RelationshipsEN 46002:1996
Draft Superseded By91/58124 DC
DescriptorsQuality assurance systems, Medical instruments, Medical equipment, Quality assurance, Quality control, Documents, Records (documents), Maintenance, Installation, Production, Inspection, Packaging, Marking, Quality auditing, Sterile equipment
ICS03.120.10
11.040.01
Title in FrenchSystèmes qualité. Dispositifs médicaux. Exigences particulières relatives à l'application de l'EN ISO 9002
Title in GermanQualitaetssicherungssysteme. Medizinprodukte. Besondere Anforderungen fuer die Anwendung von EN ISO 9002
CommitteeCH/210/1
ISBN0 580 27060 2
PublisherBSI
FormatA4
DeliveryNo
Pages14
File Size152.1 KB
Price£130.00


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