AAMI/ISO 13004:2022
2024
Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
- Format:
- Language(s) :
- Published :
- English
- 02/09/2024
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 | |
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STANDARD INFO: | |
Standard Name | AAMI/ISO 13004:2022 |
Scope | Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD |
Publisher | AAMI - Association for the Advancement of Medical Instrumentation/International Org. for Standardization |
Languages | English |
State | |
Publication Year | 2024 |
Most recent Version | MOST RECENT |
Whether to be replaced | |
Addendum | |
FILE INFO: | |
ANSI | ANSI Approved |
File Size | 1 file , 910 KB |
ISBN(s) | 9781570208881 |
Note | This product is unavailable in Ukraine, Russia, Belarus |
Number of Pages | 75 |
Published | 02/09/2024 |
AAMI/ISO 13004:2022 | ||
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History | Publisher Year | |
AAMI/ISO 13004:2022 | 2024 | Current |
AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL] | 2013 |
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