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ANSI/AAMI/ISO 14160:2011/(R)2016 - Sterilization of health care products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives-Requirements for characterization, development, validation and routin >
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ANSI/AAMI/ISO 14160:2011/(R)2016 - Sterilization of health care products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives-Requirements for characterization, development, validation and routin, 2011
- ANSI/AAMI/ISO 14160:2011/(R)2016, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, 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 ANSI/AAMI adoption of ISO 14160:2011
- Foreword
- Introduction
- 1 Scope
- 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 [Go to Page]
- 9 Validation [Go to Page]
- 10 Routine monitoring and control
- 11 Product release from sterilization
- 12 Maintaining process effectiveness [Go to Page]
- Annex A Guidance for the application of this International Standard [Go to Page]
- Annex B Determination of lethal rate of the sterilization process [Go to Page]
- Annex C Flowchart for microbicidal effectiveness (see 5.3), process definition (see Clause 8), and microbiological performance qualification (see 9.4.2)
- Bibliography [Go to Page]