DS CEN ISO/TS 13004:2014

Sterilizimi i produkteve të kujdesit shëndetësor - Rrezatimi - Vërtetimi i zgjedhjes së dozës së sterilizimit: Metoda VDmaxSD (ISO/TS 13004:2013)

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)

Publication date: 27 nën 2015

General information

Current stage: 60.60 Effective date: 27 nën 2015

Originator: DPS

Owner: DPS/KT 316

Type: Technical Specification

ICS: 11.080.01

Gjuha: anglisht

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Statusi: Publikuar

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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.

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PUBLISHED
DS CEN ISO/TS 13004:2014
60.60 Standard published
27 nën 2015

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Adopted from CEN ISO/TS 13004:2014

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