ANSI/AAMI/ISO 13004:2022
Active Standard
Most Recent

ANSI/AAMI/ISO 13004:2022

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

Summary

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. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2022
Page Count 75
Themes Sterilization—Industrial
EAN ---
ISBN ---
Weight (in grams) ---
No products.

Previous versions

Contact us