AAMI/ISO 13004:2022

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AAMI/ISO 13004:2022

2024

Most Recent

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

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This document describes a method for substantiating a select sterilization dose that achieves a sterility assurance level of 10-6 or less for radiation sterilization of health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

AAMI/ISO 13004:2022
STANDARD INFO:
Standard NameAAMI/ISO 13004:2022
ScopeSterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
PublisherAAMI - Association for the Advancement of Medical Instrumentation/International Org. for Standardization
LanguagesEnglish
State
Publication Year2024
Most recent VersionMOST RECENT
Whether to be replaced
Addendum
FILE INFO:
ANSIANSI Approved
File Size1 file , 910 KB
ISBN(s)9781570208881
NoteThis product is unavailable in Ukraine, Russia, Belarus
Number of Pages75
Published02/09/2024
AAMI/ISO 13004:2022
HistoryPublisher Year
AAMI/ISO 13004:20222024Current
AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL]2013

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