ISO／DIS 10993-2：2020.docx

DRAFTINTERNATIONA1STANDARDISO/DIS10993-2ISOTC194Votingbeginson:2023-02-13Secretariat:DINVotingterminateson:2023-05-07Bio1ogica1eva1uationofmedica1devices一Part2:Anima1we1farerequirementsEva1uationbio1ogiquedesdispositifsmdicauxPartie2:Exigencesre1ativesaIaprotectiondesanimau×ICS:11.100.20THISDOCUMENTISADRAFTCIRCU1ATEDFORCOMMENTANDAPPROVA1.ITISTHEREFORESUBJECTTOCHANGEANDMAYNOTBEREFERREDTOSANINTERNATIONA1STANDARDUNTI1PUB1ISHEDASSUCH.INADDITIONTOTHEIREVA1UATIONASBEINGACCEPTAB1EFORINDUSTRIA1TECHNO1OGICA1,COMMERCIA1ANDUSERPURPOSES.DRAFTINTERNATIONA1STANDARDSMAYONOCCASIONHAVETOBECONSIDEREDINTHE1IGHTOFTHEIRPOTENTIA1TOBECOMESTANDARDSTOWHICHREFERENCEMAYBEMADEINNATIONA1REGU1ATIONS.RECIPIENTSOFTHISDRAFTAREINVITEDTOSUBMIT.WITHTHEIRCOMMENTS.NOTIFICATIONOFANYRE1EVANTPATENTRIGHTSOFWHICHTHEYAREAWAREANDTOPROVIDESUPPORTINGDOCUMENTATION.Thisdocumentiscircu1atedasreceivedfromthecommitteesecretariat.ISO/CENPARA11E1PROCESSINGReferencenumberISO/DIS10993-2:2023(E)COPYRIGHTPROTECTEDDOCUMENT©ISO2023A11rightsreserved.Un1essotherwisespecied,orrequiredinthecontextofitsimp1ementation,nopartofthispub1icationmaybereproducedoruti1izedotherwiseinanyformorbyanymeans,e1ectronicormechanica1,inc1udingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbe1owor!SO,smemberbodyinthecountryoftherequesterISOcopyrightofficeCP401Ch.deB1andonnet8CH-1214VernieGenevaPhone:*41227490111Fax:÷41227490947Emai1:copyrightiso.orgWebsite:www.iso.orgPub1ishedinSwitzer1andPageContentsForewordIntroductionScope23Normativereferences*>MM(4Requirements34.1Genera134.2JustiHcdtionforanims1tests44.2.1Genera144.2.2Oversightframeworkofanima1useandwe1fare4.3Competenceofpersonne1-54.4P1anningandperformanceofanima1tests54.5Teststrategy-Sequenceofinvitroandinvivotests646An1ma1Careandaccomodaton61.1.3 Surgica1procedures71.1.4 Genera171.1.5 Euthanasia74.8 Studydocumentation84.9 Va1idityoftestresu1tsandmutua1acceptanceofdata8Annex A (informative)Rationa1eforthedeve1opmentofthisdocument9Annex B (informative)Furthersuggestionsforrep1acing,reducingandrefininganima1tests15Bib1iography16ForewordISO(theInternationa1OrganizationforStandardization)isawor1dwidefederationofnationa1standardsbodies(ISOmemberbodies).TheworkofpreparingInternationa1Standardsisnorma11ycarriedoutthroughISOtechnica1committees.Eachmemberbodyinterestedinasubjectforwhichatechnica1committeehasbeenestab1ishedhastherighttoberepresentedonthatcommittee,internationa1organizations,governmenta1andnon-governmenta1,in1iaisonwithISO,a1sotakepartinthework.ISOco11aboratesc1ose1ywiththeInternationa1E1ectrotechnica1Commission(IEC)ona11mattersofe1ectrotechnica1standardization.Theproceduresusedtodeve1opthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticu1ar,thedifferentapprova1criterianeededforthedifferenttypesofISOdocumentsshou1dbenoted.Thisdocumentwasdraftedinaccordancewiththeeditoria1ru1esoftheISO/IECDirectives,Part2(seeWWW,isoQigdiecUves).Attentionisdrawntothepossibi1itythatsomeofthee1ementsofthisdocumentmaybethesubjectofpatentrights.ISOsha11notbehe1dresponsib1eforidentifyinganyora11suchpatentrights.Detai1sofanypatentrightsidentifiedduringthedeve1opmentofthedocumentwi11beintheIntroductionand/orontheISO1istofpatentdec1arationsreceived(seeWWW.iso.org/patents).Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexp1anationofthevo1untarynatureofstandards,themeaningofISOspecifictermsandexpressionsre1atedtoconformityassessment,aswe11asinformationaboutISO'sadherencetotheWor1dTradeOrganization(WTO)princip1esintheTechnica1BarrierstoTrade(TBT),seewww.iso.org/iso/foreword.htm1.ThisdocumentwaspreparedbyTechnica1CommitteeISO/TC194,Bio1ogica1andc1inica1eva1uationofmedica1devices.Thisthirdeditioncance1sandrep1acesthesecondedition(ISO10993-2:2006),whichhasbeentechnica11yrevised.Themainchangescomparedtothepreviouseditionareasfo11ows:Additionofveterinarycare: c1arificationon1aboratoryanima1veterinarianandtheirresponsibi1itiesandauthority; requirementsfortrainedveterinarycarestaff; additionofI1ARGuide,IAC1AMandAAA1ACInternationa1 additionofasepticmethods,monitoring,pharmaceutica1gradeofchemica1usageforsurgery; usageofotherana1gesicsthanNSAIDs; othera1ternativessuchasTTCarementioned.A1istofa11partsintheISO10993seriescanbefoundontheISOwebsite.Anyfeedbackorquestionsonthisdocumentshou1dbedirectedtotheuser,snationa1standardsbody.Acomp1ete1istingofthesebodiescanbefoundatwww.iso.org/members.htm1.IntroductionThegoa1oftheISO10993seriesOf1nternationa1Standardsistheprotectionofhumansinthecontextoftheuseofmedica1devices.Thisdocumentsupportsthegoa1oftheISO10993seriesbypromotinggoodsciencethroughpaying