English - 15
003-2707-99
© Midmark Corporation 2015 TP202 20-42-FO-00014 Rev A1 C2169
Guidelines for Loading
Types of Items
BeforeplacinganyinstrumentintheM9orM11,checkwiththeinstrumentmanufacturertobesurethe
materialsarecompatiblewithsteamsterilization,andtoverifytheacceptabilityofsterilization
parameters. The M9 and M11 are designed to sterilize the following:
• Metalinstruments
• Rubber/plasticdevices(ex. suction cannulas, impression trays, etc.)
• Wrapping/bundlingmaterials(ex. CSR wrap, instrument pouches, etc.)
• Cassettes(whichtinthesterilizertraysorthecassetterackaccessories)
• High/lowspeedhandpieces
• Surgicalinstruments(ex. opthalmologic instruments)
Equipment Alert
Do not sterilize items composed of any of the following materials in the M9 or M11.
• Corrosion sensitive metal (ex. carbon steel, iron, etc.)
• Fragile items susceptible to breaking under pressure / high temperature
• Biomedical waste
• Plastics that may break down or produce residue when exposed to steam / high
temperatures.
Examples
Polyethylene,Styrene,Cellulosics,ABS,PVC,Acrylic(Plexiglass™),PPO(Noryl™),
Latex,andNeoprene
Qualication Testing
Yoursterilizershouldbetestedaftersterilizerinstallation,malfunctions,relocation,majorrepairs,and
aftersterilizationprocessfailure.Qualicationtestingshouldbeperformedpriortoplacingthesterilizerin
service.Ifmultiplecyclestypesareused,e.g.“Pouches”and“Packs”eachcycletypeshouldbequalied.
QualicationtestingshouldincludeatleastoneBiologicalIndicator(BI)(sometimesreferredtoasSpore
Tests)andoneChemicalIndicator(CI).Thetestpackshouldbeperformedwithitemsroutinelyprocessed
andconsideredtobethemostdifculttosterilize.Additionalitemsshouldbeplacedinthechamberalong
withtheBiologicalIndicatorandChemicalIndicatorsothatchamberisfullyloaded(don’texceedthe
maximumcapacitieslistedinthetablesunder“GuidelinesforLoading”inthismanual).Threeconsecutive
testruns,foreachcycletypetested,withnegativeresultsfromtheBIs,andtheappropriatereadingsfrom
allphysicalmonitorsandchemicalindicatorsdemonstratingcompletesterilization,providevericationthat
the sterilizer has been properly installed (or reinstalled after relocation) or repaired to the manufacturer’s
specicationsandthatitwillfunctioneffectivelyinthefacilityinwhichitisinstalled.Allitemsprocessed
duringqualicationtestingshouldbequarantineduntiltheresultsofthebiologicaltestingforallthreetest
runs are available.