Scottish HTM 2031 - Clean steam for sterilization

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1、ScottishHealthTechnicalMemorandum2031(Part1of1)CleansteamforsterilizationDisclaimerThecontentsofthisdocumentareprovidedbywayofguidanceonly.Anypartymakinganyusethereoforplacinganyreliancethereonshalldosoonlyuponexerciseofthatparty’sownjudgementastotheadequacyofthecontents

2、intheparticularcircumstancesofitsuseandapplication.NowarrantyisgivenastotheaccuracyofthecontentsandthePropertyandEnvironmentForumExecutive,whichproducedthisdocumentonbehalfofNHSScotlandPropertyandEnvironmentForum,willhavenoresponsibilityforanyerrorsinoromissionstherefrom

3、.TheproductionofthisdocumentwasjointlyfundedbytheScottishExecutiveHealthDepartmentandtheNHSScotlandPropertyandEnvironmentForum.NHSScotland,P&EFEx,June2001SHTM2031:CleansteamforsterilizationExecutivesummaryThequalityofsteamsuppliedtoasterilizercanhaveamajorinfluenceonthee

4、fficacyofthesterilizationprocess,thequalityofthesterileproductandthelongevityandserviceabilityofthesterilizeranditsassociatedequipment.Whereconcernforsteamqualityhastraditionallyfocusedonitsphysicalcharacteristics-notablydrynessandthepresenceofnon-condensablegases-newEur

5、opeanStandardssupportinglegislationgoverningthemanufactureofmedicaldevicesrequiremorecomprehensivecontrolofthepurityofthesterilizingenvironment.ThisSHTMdiscussesthenature,effectsandsourcesofchemicalandbiochemicalcontaminantsinsteam,andproposesareadilyachievablepurityspec

6、ificationfor“cleansteam”tobeusedforsterilization.Thespecificationisdesignedtomeetregulatoryrequirementsformedicinalproductsandmedicaldeviceswithoutincurringexcessiveexpenditure.CleansteamisdefinedassteamwhosecondensatemeetsthepurityrequirementsofWaterforInjectionsBP(incl

7、udingalimitonpyrogens)withadditionalspecificationstoprotectagainstcorrosionofmaterialsusedintheconstructionofsterilizersandmedicaldevices.Practicalguidanceisgivenonthegenerationofcleansteamfromthefollowingsources:a.fromtheexistingmainssteamsuppliescommonlyusedinhospitals

8、;b.fromdedicatedclean-steamgenerators;c.insterilizerswithaninternalsteamsupply,suchastransportablesteri