Transcription of CHAPTER 23 STERILE MEDICAL DEVICE PACKAGE …
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23 STERILE MEDICAL DEVICEPACKAGE DEVELOPMENTP atrick J. NolanDDL Inc., Eden Prairie, HISTORY PACKAGE OF A PACKAGE PACKAGE TYPES SHELF LIFE STUDIES PACKAGING MATERIALS PACKAGE VALIDATION TESTING CHAPTER provides an overview of the process of designing and developing a PACKAGE system fora MEDICAL DEVICE . A comprehensive discussion of this subject is beyond the scope of this CHAPTER ;however, numerous references are provided for further detail and study of the subject. The informa-tion provided in this CHAPTER is a compilation from the references cited as well as from the experiencesof the author in developing PACKAGE systems for MEDICAL of a standard for the process of designing and developing a PACKAGE for terminallysterilized MEDICAL devices is ess
23.1 CHAPTER 23 STERILE MEDICAL DEVICE PACKAGE DEVELOPMENT Patrick J. Nolan DDL Inc., Eden Prairie, Minnesota 23.1 REGULATORY HISTORY 23.223.6 PACKAGE PROCESS
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