AAMI TIR76:2021

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S

Association for the Advancement of Medical Instrumentation , 03/31/2021

Publisher: AAMI

File Format: PDF

$129.00$259.00

Description

Standard By:Association for the Advancement of Medical Instrumentation , 03/31/2021

Published:03/31/2021

Pages:48

ISBN(s):9781570208188

File Size:1 file , 1.6 MB

Language:English

Note:This product is unavailable in Belarus, Russia, Ukraine

This technical information report describes a method for substantiating a selected sterilization dose that achieves maximally a selected sterility assurance level (SAL) for radiation sterilization of healthcare products and a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

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