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ANSI/AAMI/ISO 14937:2009/(R) 2013 - Sterilization of health care products-General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices >
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ANSI/AAMI/ISO 14937:2009/(R) 2013 - Sterilization of health care products-General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices, 2009
- ANSI/AAMI/ISO 14937:2009/(R)2013, Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee Representation
- Background of AAMI adoption of ANSI/AAMI/ISO 14937
- Foreword
- Introduction
- 1 Scope [Go to Page]
- 2 Normative references
- 3 Terms and definitions
- 4 Quality management system elements [Go to Page]
- 5 Sterilizing agent characterization [Go to Page]
- 6 Process and equipment characterization [Go to Page]
- 7 Product definition
- 8 Process definition
- 9 Validation [Go to Page]
- 10 Routine monitoring and control
- 11 Product release from sterilization
- 12 Maintaining process effectiveness [Go to Page]
- Annex A Factors to be considered in selection of microorganisms for demonstrating microbicidal effectiveness [Go to Page]
- Annex B Approach 1 — Process definition based on inactivation of the microbial population in its natural state [Go to Page]
- Annex C Approach 2 — Process definition based on inactivation of reference microorganisms and knowledge of bioburden [Go to Page]
- Annex D Approach 3 — Conservative process definition based on inactivation of reference microorganisms [Go to Page]
- Annex E Guidance on application of this International Standard [Go to Page]
- Bibliography [Go to Page]
