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AAMI 11737 1 2018 A1 2021

AAMI 11737 1 2018 A1 2021

$80.17

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

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AAMI 2018
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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.

PDF Catalog

PDF Pages PDF Title
1 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
3 Title page
4 AAMI Standard
Copyright information
5 Contents
6 Committee representation
11 Background of ANSI/AAMI adoption of ISO 11737-1:2018/A1:2021
12 Foreword
13 ANSI/AAMI/ISO 11737-1:2018/A1:2021

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AAMI 11737 1 2018 A1 2021
$80.17