nsBAS EN ISO 13004:2024
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
General information
Status:Project
Number of pages:61
Adoption method:Proglašavanje
Language:engleski
Edition:2.
Realization date:28.03.2024
Forseen date for next stage code:27.05.2024
Technical committee:BAS/TC 25, Healthcare
ICS:
11.080.01, Sterilization and disinfection in general
Abstract
Adoption of ISO 13004:2022 – This is currently in FDIS and will be publishing in October 2022.
This document 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. This Technical Specification also specifies a method of sterilization
dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
NOTE Selection and substantiation of the sterilization dose is used to meet the requirements for establishing
the sterilization dose within process definition in ISO 11137-1.
Lifecycle
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Original document and degree of correspondence
EN ISO 13004:2023, identical
ISO 13004:2022, identical
Relation to BAS standards
Work material
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