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AAMI/ISO 13004:2022

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

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 02/09/2024

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Full Description

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.

 

Product Details

Published:
02/09/2024
ISBN(s):
9781570208881
ANSI:
ANSI Approved
Number of Pages:
75
File Size:
1 file , 910 KB
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This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 13004:2022

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

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  2. AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL]


    Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD [HISTORICAL]

    • Historical Version