SS-EN-ISO-13004 › Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

SS-EN-ISO-13004 - 2023 EDITION - CURRENT


Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:


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.

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

ORDER

Price:

$230.70        


Want this as a site license?



Designation Name

SS-EN ISO 13004:2023

Revision Level

2023 EDITION

Status

Current

Publication Date

July 4, 2023

Language(s)

English

Page Count

68

International Equivalent

EN ISO 13004:2023(IDT); ISO 13004:2022(IDT)