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STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT
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Available format(s): Hardcopy, PDF
Superseded date: 09-05-2020
Language(s): English
Published date: 01-01-2011
Publisher: Association for the Advancement of Medical Instrumentation
Glossary of equivalent standardsCommittee representation Background of AAMI adoption of ISO 11737-1:2006Foreword Introduction 1 Scope2 Normative references3 Definitions4 Quality management system elements 4.1 Documentation 4.2 Management responsibility 4.3 Product realization 4.4 Measurement, analysis, and improvement - Control of nonconforming product5 Selection of product 5.1 General 5.2 Sample item portion (SIP)6 Methods of determination and microbial characterization of bioburden 6.1 Determination of bioburden 6.1.1 Selection of an appropriate method 6.1.2 Removal of microorganisms 6.1.3 Culturing of microorganisms 6.1.4 Enumeration of microorganisms 6.2 Microbial characterization of bioburden7 Validation of method of determination of bioburden8 Routine determination of bioburden and interpretation of data9 Maintenance of the method of determination of bioburden 9.1 Changes to the product and/or manufacturing process 9.2 Changes to the method of determination of bioburden 9.3 Revalidation of the method of determination of bioburdenAnnexesA - Guidance on determination of a population of microorganisms on productB - Guidance on methods of determination of bioburdenC - Validation of bioburden methodsBibliography
Describes requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material, or package.
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