AAMI TIR35:2016 PDF Download
Standard EN Sample
Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
Also Known As:
SKU142672575
Published by
Association for the Advancement of Medical Instrumentation
AAMI
Publication Date2016-06-05
Pages CountPages36
Full Description
Describes approaches to the selection and auditing of a sterilization dose that may reduce the number of product items required while maintaining assurance of attaining the desired sterility assurance level (SAL). This approach addresses sampling plans for verification dose experiments and sterilization dose audits. In addition the approaches to adopting a product into an established product family are defined.
Details
| Language(s) | English |
| ISBN | 157020618X |
| File Size | 1.1 MB |
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