Name:
AAMI/ISO 13004:2022 PDF
Published Date:
02/09/2024
Status:
Active
Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization
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.
| 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 |
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