haTmed Q70B - Page 25

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thecycleis134°C,theholdingtimeshouldbenotlessthan3
minutes.
 Chemical monitoring should be performed for each sterilization
cycle,byobservingthecolorchangeofthechemicalindicatorto
determine whether the sterilization requirement is met
compliancewiththeinformationandrequirementsprovidedby
themanufacturerofthechemicalindicator.
 Sterilization monitoring shall comply with the requirements of
AnnexEofWS506‐2016
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 Thenationalstandardsforsterilization,WS310‐2016stipulatethat
thesterilizeroperatingcycleparametersshouldbefullyrecorded
andstoredfor3years.
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4.7 SterileStorage
Sterilepackagestoragetimeaftersterilizationvarieswithpackagingmaterialandstorageconditions,infull
compliancewiththespecification.Forexample,theconditionofWS310‐2016canbestoredforupto6months.
PackagingrequirementsandstorageconditionspleasefollowWS310‐2016.
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 Pleasefollowthepackagingmanufacturer'srecommendationsor
regulationsforthestoragetimeofthesterilepackage.
 Donotstoresterileitemsincontaminatedareas.
 Sterileitemsmustbestoredinadust‐free,(Inadditiontowater,
other liquids such as alcohol, disinfectants, etc. should also be
avoided)drytemperaturesuitableenvironment.
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