CLSI M52-2015(R2020) Verifcation of Commercial Microbial Identifcation and Antimicrobial Susceptibility Testing Systems 工业微生物鉴定和药敏试验系统的验证.pdf

ClinicalandLaboratorvStandardsInstitute

k忱的gthe拭目ndardforqualityinclinicallabor，日orytestingaroundtheworld.

TheClinicalandLaboratoryStandardsInstitute(CLSI)isanot-for-profitmembershiporganizationthatbrings

togetherthevariedperspectivesandexpertiseoftheworldwidelaboratorycommunityfortheadvancementof

acommoncause:tofosterexcellenceinlaboratorymedicinebydevelopingandimplementingclinicallabo旧tory

standardsandguidelinesthathelplaboratoriesfulfilltheirresponsibilitieswithe简ciency,e仔ectiveness,andglobal

applicability.

ι。nsensusProcess

Consensus-thesubstantialagreementbymateriallya仔ected,competent,andinterestedparties-iscoretothe

developmentofallCLSId。cuments.Itdoesnotalwaysconnoteunanimousagreement,butdoesmeanthatthe

participantsinthedevelopmentofaconsensusdocumenthaveconsideredandresolvedallrelevantobjections

andaccepttheresultingagreement.

E。mmentingonD。cuments

CLSIdocumentsundergoperiodicevaluationandmod而cationtokeeppacewithadvancementsintechnologies,

procedures,methods,andprotocolsa仔ectingthelaboratoryorhealthcare

CLSlsconsensusprocessdependsonexpertswhovolunteertoserveascontributingauthorsand/orasparticipants

inthereviewingandcommentingprocess.Attheendofeachcommentperiod,thecommitteethatdeveloped

thedocumentisobligatedtoreviewallcomments,respondinwritingtoallsubstantivecomments,andrevisethe

draftdocumentasappropriate.

ζommentsonpublishedCLSIdocumentsareequallyessential,andmaybesubmittedbyanyone,atanytime,on

anydocument.Allcommentsareaddressedaccordingtotheconsensusprocessbyacommitteeofexperts.

AppealsProcess

Ifitisbelievedthatanobjecti。nhasnotbeenadequatelyaddressed,theprocessforappealsisdocumentedinthe

CLSIStandardsDevelopmentPoliciesandProcesses.

Allcommentsandresponsessubmittedondraftan