PD CEN ISO/TS 13004:2014 - Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VD<sub>max</sub>SD

PD CEN ISO/TS 13004:2014

Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD

Status : Current   Published : February 2014

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ISO/TS 13004:2013 describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10?6 or less for radiation sterilization of health care products. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.




Standard NumberPD CEN ISO/TS 13004:2014
TitleSterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
StatusCurrent
Publication Date28 February 2014
Normative References(Required to achieve compliance to this standard)ISO 11737-2:2019, ISO 11737-1:2018, BS EN ISO 11737-2:2019, ISO 11137-1:2006
Informative References(Provided for Information)ISO 11137-3:2017, ISO 11137-2
International RelationshipsCEN ISO/TS 13004:2014,ISO/TS 13004:2013
Amended ByCorrigendum, July 2014
DescriptorsVerification, Medical technology, Health services, Radiation, Products, Medical equipment, Sterilization (hygiene), Microorganisms
ICS11.080.01
Title in FrenchStérilisation des produits de santé. Irradiation. Justification de la dose de stérilisation choisie: méthode VDmaxSD
Title in GermanSterilisation von Produkten für die Gesundheitsfürsorge. Strahlen. Bestätigung der gewählten Sterilisationsdosis: Methode VDmaxSD
CommitteeCH/198
ISBN978 0 580 85152 0
PublisherBSI
FormatA4
DeliveryYes
Pages68
File Size1.825 MB
Price£254.00


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