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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device interim reprocessing cleaning and intermediate-level disinfection wipe
Definition An interim reprocessing cleaning and intermediate-level disinfection wipe is intended for use by a health care provider to clean and intermediate-level disinfect medical device types indicated on the labeling as an interim step prior to sterilization or high-level disinfection. This is intended as a non-terminal disinfection step compatible with subsequent terminal reprocessing such as sterilization or high-level disinfection and renders the device safe to handle by the user compared to unprocessed, clinically soiled devices. “Safe to handle” is limited in scope to mean the device has been appropriately intermediate-level disinfected.
Product CodeSHM
Regulation Number 880.6891
Device Class 2


Premarket Reviews
ManufacturerDecision
STERIS
  GRANTED 1

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