BS EN ISO 14160:2011 - Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices

BS EN ISO 14160:2011

Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices

Status : Current, Under review   Published : July 2011

Format
PDF

Format
HARDCOPY






Standard NumberBS EN ISO 14160:2011
TitleSterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
StatusCurrent, Under review
Publication Date31 July 2011
Normative References(Required to achieve compliance to this standard)ISO 11737-1:2018, ISO 13485:2003, ISO 10993-1, ISO 13408, ISO 10012, ISO 22442-2, ISO 10993-17
Informative References(Provided for Information)ANSI/AAMI ST67:2003, ISO 17665-1:2006, EN 556-1, ISO 22442-3, ISO 9004, ISO 11135-1, ISO 14937, ISO 22442-1, ISO/TS 11139:2006, 93/42/EEC, ISO/IEC 90003, ISO 11137-1, ISO 11737-2:2019, ISO 11138-1:2017, BS EN ISO 11737-2:2020, ISO 14161
ReplacesBS EN ISO 14160:1998
International RelationshipsEN ISO 14160:2011,ISO 14160:2011
Draft Superseded By09/30157765 DC
DescriptorsMaintenance, Disposable, Microbiological analysis, Certification (approval), Animal products, Sterile equipment, Liquids, Compatibility, Medical instruments, Personnel, Performance, Quality control, Medical equipment, Sterilization (hygiene), Microorganisms, Verification
ICS11.080.01
Title in FrenchStérilisation des produits de santé. Agents stérilisants chimiques liquides pour dispositifs médicaux non réutilisables utilisant des tissus animaux et leurs dérivés. Exigences pour la caractérisation, le développement, la validation et le contrôle de routine d'un procédé de stérilisation de dispositifs médicaux
Title in GermanSterilisation von Produkten für die Gesundheitsfürsorge. Flüssige chemische Sterilisiermittel für Medizinprodukte für den einmaligen Gebrauch, bei denen tierische Gewebe und deren Derivate verwendet werden. Anforderungen an die Charakterisierung, Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte
CommitteeCH/198
ISBN978 0 580 57851 9
PublisherBSI
FormatA4
DeliveryYes
Pages46
File Size1.105 MB
Price£240.00


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