Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1 and Part 2:2006, (now includes 2008 amendment)
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Acquisition and use of physiologic waveform databases for testing of medical devices
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Ventricular assist and heart replacement systems
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Product adoption and process equivalency for ethylene oxide sterilization
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Product adoption and process equivalency for ethylene oxide sterilization
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Product adoption and process equivalency for ethylene oxide sterilization
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Guide for process control in radiation sterilization
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Guide for process characterization and control in radiation sterilization of medical devices
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A Compendium of Processes, Materials, Test Methods and Acceptance Criteria for Cleaning Reusable Medical Devices
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