GHTF-SC-N4-2012 Glossary and Definitions of Terms Used in GHTF Documents

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1、DefinitionandGlossaryofTermsUsedinGHTFDocumentsGHTFSteeringCommitteeFinalDocumentGHTF/SC/N4:2012(Edition2)PrefaceThedocumenthereinwasproducedbytheGlobalHarmonizationTaskForce,avoluntarygroupofrepresentativesfrommedicaldeviceregulatoryagenciesandtheregulatedindustry.Thedocumentisinten

2、dedtoprovidenon-bindingguidanceforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.Therearenorestrictionsonthereproduction,distributionoruseofthisdocument;however,incorporationofthisdocument,inpartorinwhole,intoanyotherdocument,oritstranslati

3、onintolanguagesotherthanEnglish,doesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmonizationTaskForce.1.0IntroductionThepurposeofthisdocumentistopublishalistofdefinitionsusedinallGHTFFinalDocumentsforuseasaGHTFGlossaryofTerms.2.0Rationale,PurposeandScopeGHTFguidancedocument

4、shavebeenwrittenbydifferentStudyGroupsand,whenfinalised,arepublishedbytheGHTFonitswebsite.Manyincludealistofthedefinitions.ThisparticulardocumentconsolidatesthesedefinitionsintoasinglelistandwillimproveunderstandingoftheguidanceprovidedinGHTFFinalDocuments.3.0ReferencesAllGHTFFinalDo

5、cuments.4.0DefinitionsItshouldbenotedthatthisdocumentisintendedasaninformationpaperonlyandisnotintendedtobeadefinitivedictionaryofeachterm.Insomeinstancestheremaybemorethanonedefinitionforasingleterm.Wherethisoccursitisrecommendedthatthereaderrefertothesourcedocumentsinwhichtheyarere

6、ferencedtoensurethetermsareunderstoodinthecorrectcontext.Itshouldalsobenotedthatsomedefinitionsarederivedfrominternationalornationalstandards,guidanceorregulations.Wheresuchdefinitionsareusedherein,itisrecommendedthatreadersrefertotheoriginalsourcedocuments.5.0ExistingDefinitionsinGH

7、TFdocumentsDefinitions,whichappearinGHTFFinalDocuments,arelistedinAppendixA.Whenwritinganewdocumentormodifyinganexistingone,therelevantStudyGroupshouldreviewtheGlossaryofTermsintheAppendixanduseadefinitionfromthelistwheneverpossible.WhensubmittingaguidancedocumenttotheGHTFSteeringCom

8、mitteeforend