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ANSI/AAMI/ISO 11737-1:2018/A1:2021

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - AMENDMENT 1

AMENDMENT ONLY - ISO 11737-1:2018 was developed to specify general criteria to be applied in the estimation of the population of viable microorganisms on a medical device or component, raw material, or packaging. This amendment expands on general information relating to the development, validation, and routine control of a sterilization process. It also adds a requirement for calibration of all equipment used to meet requirements. This amendment updates the method for calculating the most probable number.

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Association for the Advancement of Medical Instrumentation [aami]

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