EN ISO 10993-8:2000
(Main)Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)
Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage ++ ISO Standard withdrawn (NT/041123)
Biologische Beurteilung von Medizinprodukten - Teil 8: Auswahl und Eignung von Referenzmaterialien für biologische Prüfungen (ISO 10993-8:2000)
Dieser Teil von ISO 10993 legt Anforderungen an die Verwendung von Referenzmaterialien oder zertifizierten Referenzmaterialien fest, die bei der Bestimmung der biologischen Reaktion eines Materials verwendet werden. Er beschreibt die Auswahl und Eignung von Referenzmaterialien für biologische Prüfungen und die Eigenschaften von Referenzmaterialien zur Verwendung als Versuchskontrollen.
Evaluation biologique des dispositifs médicaux - Partie 8: Sélection et qualification des matériaux de référence utilisés pour les essais biologiques (ISO 10993-8:2000)
Biološko ovrednotenje medicinskih pripomočkov - 8. del: Izbira in ugotavljanje referenčnih materialov za biološke preskuse (ISO 10993-8:2000)
General Information
- Status
- Withdrawn
- Publication Date
- 31-Aug-2000
- Withdrawal Date
- 31-Jan-2005
- Technical Committee
- CEN/TC 206 - Biocompatibility of medical and dental materials and devices
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 01-Feb-2005
- Completion Date
- 01-Feb-2005
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 09-Feb-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN ISO 10993-8:2000 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)". This standard covers: Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage ++ ISO Standard withdrawn (NT/041123)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage ++ ISO Standard withdrawn (NT/041123)
EN ISO 10993-8:2000 is classified under the following ICS (International Classification for Standards) categories: 11.100 - Laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 10993-8:2000 has the following relationships with other standards: It is inter standard links to EN 60601-1:2006/A2:2021, CEN/TS 15277:2006, EN 455-3:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 10993-8:2000 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC, 98/79/EC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN ISO 10993-8:2000 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biologische Beurteilung von Medizinprodukten - Teil 8: Auswahl und Eignung von Referenzmaterialien für biologische Prüfungen (ISO 10993-8:2000)Evaluation biologique des dispositifs médicaux - Partie 8: Sélection et qualification des matériaux de référence utilisés pour les essais biologiques (ISO 10993-8:2000)Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)11.100.20Biological evaluation of medical devicesICS:Ta slovenski standard je istoveten z:EN ISO 10993-8:2000SIST EN ISO 10993-8:2001en01-november-2001SIST EN ISO 10993-8:2001SLOVENSKI
STANDARD
ReferencenumberISO10993-8:2000(E)©ISO2000INTERNATIONALSTANDARDISO10993-8Firstedition2000-09-01Biologicalevaluationofmedicaldevices—Part8:SelectionandqualificationofreferencematerialsforbiologicaltestsÉvaluationbiologiquedesdispositifsmédicaux—Partie8:SélectionetqualificationdesmatériauxderéférenceutiliséspourlesessaisbiologiquesSIST EN ISO 10993-8:2001
ISO10993-8:2000(E)PDFdisclaimerThisPDFfilemaycontainembeddedtypefaces.InaccordancewithAdobe'slicensingpolicy,thisfilemaybeprintedorviewedbutshallnotbeeditedunlessthetypefaceswhichareembeddedarelicensedtoandinstalledonthecomputerperformingtheediting.Indownloadingthisfile,partiesacceptthereintheresponsibilityofnotinfringingAdobe'slicensingpolicy.TheISOCentralSecretariatacceptsnoliabilityinthisarea.AdobeisatrademarkofAdobeSystemsIncorporated.DetailsofthesoftwareproductsusedtocreatethisPDFfilecanbefoundintheGeneralInforelativetothefile;thePDF-creationparameterswereoptimizedforprinting.EverycarehasbeentakentoensurethatthefileissuitableforusebyISOmemberbodies.Intheunlikelyeventthataproblemrelatingtoitisfound,pleaseinformtheCentralSecretariatattheaddressgivenbelow.©ISO2000Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromeitherISOattheaddressbeloworISO'smemberbodyinthecountryoftherequester.ISOcopyrightofficeCasepostale56CH-1211Geneva20Tel.+41227490111Fax+41227490947E-mailcopyright@iso.chWebwww.iso.chPrintedinSwitzerlandii©ISO2000–AllrightsreservedSIST EN ISO 10993-8:2001
ISO10993-8:2000(E)©ISO2000–AllrightsreservediiiForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part3.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.AttentionisdrawntothepossibilitythatsomeoftheelementsofthispartofISO10993maybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.InternationalStandardISO10993-8waspreparedbyTechnicalCommitteeISO/TC194,Biologicalevaluationofmedicaldevices.ISO10993consistsofthefollowingparts,underthegeneraltitleBiologicalevaluationofmedicaldevices:—Part1:Evaluationandtesting—Part2:Animalwelfarerequirements—Part3:Testsforgenotoxicity,carcinogenicityandreproductivetoxicity—Part4:Selectionoftestsforinteractionswithblood—Part5:Testsforinvitrocytotoxicity—Part6:Testsforlocaleffectsafterimplantation—Part7:Ethyleneoxidesterilizationresiduals—Part8:Selectionandqualificationofreferencematerialsforbiologicaltests—Part9:Frameworkforidentificationandquantificationofpotentialdegradationproducts—Part10:Testsforirritationandsensitization—Part11:Testsforsystemictoxicity—Part12:Samplepreparationandreferencematerials—Part13:Identificationandquantificationofdegradationproductsfrompolymericmedicaldevices—Part14:Identificationandquantificationofdegradationproductsfromceramics—Part15:Identificationandquantificationofdegradationproductsfrommetalsandalloys—Part16:ToxicokineticstudydesignfordegradationproductsandleachablesSIST EN ISO 10993-8:2001
ISO10993-8:2000(E)iv©ISO2000–Allrightsreserved—Part17:Establishmentofallowablelimitsforleachablesubstancesusinghealth-basedriskassessment—Part18:ChemicalcharacterizationofmaterialsFuturepartswilldealwithotherrelevantaspectsofbiologicaltesting.SIST EN ISO 10993-8:2001
ISO10993-8:2000(E)©ISO2000–AllrightsreservedvIntroductionTheinformationgiveninthispartofISO10993shouldbeconsideredasasupplementtoISO10993-12whichspecifiesrequirementsandgivesguidanceonprocedurestobefollowedinthepreparationofsamplesofmedicaldevicesfortestinginbiologicalsystemsinaccordancewithoneormorepartsoftheISO10993series.Inclause4ofISO10993-12:1996,thereisadiscussionoftheuseofreferencematerialsasexperimentalcontrols.AnnexAofISO10993-12:1996providesspecificinformationregardingcurrentsourcesofcommerciallyavailablereferencematerials.SIST EN ISO 10993-8:2001
INTERNATIONALSTANDARDISO10993-8:2000(E)©ISO2000–Allrightsreserved1Biologicalevaluationofmedicaldevices—Part8:Selectionandqualificationofreferencematerialsforbiologicaltests1ScopeThispartofISO10993specifiesrequirementsontheuseofreferencematerialsorcertifiedreferencematerialsusedtodeterminethebiologicalresponseofamaterial.Itspecifiestheselectionandqualificationofreferencematerialsforbiologicaltestsandthecharacteristicsofreferencematerialsfortheuseofreferencematerialsasexperimentalcontrols.2NormativereferencesThefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext,constituteprovisionsofthispartofISO10993.Fordatedreferences,sub
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