BS EN ISO 13488:2001 - Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002 – BSI British Standards

BS EN ISO 13488:2001

Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002

Status : Superseded, Withdrawn   Published : March 2001 Replaced By : BS EN ISO 13485:2003

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Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996)

Executive summary

Quality system requirements for the production, installation and servicing of medical devices.

Abstract

This International Standard specifies, in conjunction with ISO 9002, the quality system requirements for the production and, when relevant, installation and servicing of medical devices.

This International Standard, in conjunction with ISO 9002, is applicable when there is a need to assess a medical device supplier's quality system.

This standard embraces all the principles of good manufacturing practice (GMP) widely used in the manufacture of medical devices. It can only be used in combination with ISO 9002 and is not an independent standard.

History and related standards

This International Standard supersedes BS EN 46002:1997 which is withdrawn.

This Standard includes the following cross references:

ISO 8402:1994, ISO 9002:1994, ISO 11137:1995.




Standard NumberBS EN ISO 13488:2001
TitleQuality systems. Medical devices. Particular requirements for the application of EN ISO 9002
StatusSuperseded, Withdrawn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Withdrawn Date01 July 2006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 46002:1997
International RelationshipsEN ISO 13488:2001,ISO 13488:1996
DescriptorsMedical equipment, Quality assurance, Quality control, Quality assurance systems, Medical instruments, Quality auditing
ICS03.120.10
11.040.01
Title in FrenchSystemes qualite. Dispositifs medicaux. Exigences particulieres relatives a 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 36991 9
PublisherBSI
FormatA4
DeliveryNo
Pages20
File Size1.178 MB
Price£130.00


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