BS EN ISO 14937:2001 - Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

BS EN ISO 14937:2001

Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

Status : Revised, Withdrawn   Published : March 2001 Replaced By : BS EN ISO 14937:2009

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Standard NumberBS EN ISO 14937:2001
TitleSterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
StatusRevised, Withdrawn
Publication Date15 March 2001
Withdrawn Date31 March 2010
Normative References(Required to achieve compliance to this standard)ISO 10012-1, ISO 10012-1:1992, ISO 10993-1, ISO 10993-17, ISO 11138-1, ISO 11140-1, ISO 11737-1, ISO 11737-2, ISO 13485, ISO 13488, IEC 61010-1, ISO 10993-1:1997, ISO 11737-2:1998, ISO 13485:1996, ISO 13488:1996, EN 30012-1:1993, EN ISO 10993-1:1997, EN ISO 11737-2:2000, EN ISO 13485:2000, EN ISO 13488:2000
Informative References(Provided for Information)EN 556, ISO 9000-3, ISO 9001, ISO 9004, ISO 11134, ISO 11135, ISO 11137, ISO 13683, ISO 14160, ISO 14161, ISO 11607, ISO 14001, ISO 14040, IEC 61010-2-041, IEC 61010-2-042, ISO 9001:1994, ISO 9002
Replaced ByBS EN ISO 14937:2009
International RelationshipsEN ISO 14937:2000,ISO 14937:2000
Amended ByAmd 13353 (Corr to BS EN ISO 14937:2001)
AMD 15195
AMD 17059, April 2007. AMD 13353, AMD 15195 and AMD 17059 are Corrigenda.
Draft Superseded By99/562423 DC
DescriptorsSterilization (hygiene), Sterile equipment, Sterilizers, Medical equipment, Medical instruments, Process control, Quality control, Verification
ICS11.080.01
Title in FrenchSterilisation des produits de sante. Exigences generales pour la caracterisation d'un agent sterilisant et pour le developpement, la validation et la verification de routine d'un processus de sterilisation pour dispositifs medicaux
Title in GermanSterilisation von Medizinprodukten. Allgemeine Anforderungen an die Charakterisierung eines Sterilisiermittels und an die Entwicklung, Validierung und Routineueberwachung eines Sterilisationsverfahrens fuer Medizinprodukte
CommitteeCH/198
ISBN0 580 37085 2
PublisherBSI
FormatA4
DeliveryNo
Pages50
File Size1.014 MB
Price£240.00


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