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Basic Concepts in Validation and Qualification of Cleaning and Sterilization Processes for Reusable Medical Devices

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Basic Concepts in Validation and Qualification of Cleaning and Sterilization Processes for Reusable Medical Devices

Book by Association for the Advancement of Medical Instrumentation, 2021

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Basic Concepts in Validation and Qualification of Cleaning and Sterilization Processes for Reusable Medical Devices is a timely update to Donna Swenson's bestselling resource for sterile processing personnel and medical device manufacturers.

The book covers basic information about the science behind sterilization, quality management, and the principles of validation. The text then applies those principles to cleaning processes, the validation of various sterilization processes, and product quality assurance testing of cleaning and sterilization processes. The intent of the book is to help sterile processing and medical device manufacturing personnel be on the "same page" and able to use the same language and concepts in discussing and understanding cleaning and sterilization processes.

Includes key definitions and abbreviations, as well as practical tools for real-world implementation of the concepts.