Transcription of CHAPTER 23 STERILE MEDICAL DEVICE PACKAGE …
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CHAPTER 23 STERILE MEDICAL DEVICE PACKAGE …
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 essential to the overall endeavor of marketing a STERILE DEVICE in theinternational and domestic communities.
STERILE MEDICAL DEVICE PACKAGE DEVELOPMENT 23.3 A government committee studied the best approach to new comprehensive device legislation, and, as a result, in 1976 a new law amended the 1938 Act and provided the FDA with significant
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