iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
SIST

SIST EN ISO 10993-8:2001

(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(TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage ++ ISO Standard withdrawn (NT/041123)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Withdrawn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-Oct-2001
Withdrawal Date
30-Jun-2005
ICS
11.100.20 - Biological evaluation of medical devices
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
01-Jul-2005
Due Date
01-Jul-2005
Completion Date
01-Jul-2005
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
EN ISO 10993-8:2000 - Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)

Buy Standard

EN ISO 10993-8:2001EN ISO 10993-8:2001
PreviousNext
Standard
EN ISO 10993-8:2001
English language
7 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

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



SIST EN ISO 10993-8:2001



SIST EN ISO 10993-8:2001



SIST EN ISO 10993-8:2001



SIST EN ISO 10993-8:2001



SIST EN ISO 10993-8:2001



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



SIST EN ISO 10993-8:2001



INTERNATIONALSTANDARDISO10993-8:2000(E)©ISO2000–Allrightsreserved1Biologicalevaluationofmedicaldevices—Part8:Selectionandqualificationofreferencematerialsforbiologicaltests1ScopeThispartofISO10993specifiesrequirementsontheuseofreferencematerialsorcertifiedreferencematerialsusedtodeterminethebiologicalresponseofamaterial.Itspecifiestheselectionandqualificationofreferencematerialsforbiologicaltestsandthecharacteristicsofreferencematerialsfortheuseofreferencematerialsasexperimentalcontrols.2NormativereferencesThefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext,constituteprovisionsofthispartofISO10993.Fordatedreferences,sub
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

SIST
SIST EN ISO 10993-15:2023(Main)
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
EN ISO 10993-15:2023

NEXT ACTION: TC ACTION BY 2022-10-26 : TC to send a revised annex ZA for assessment at PUB
2020-02-19- JO-CEN/TC 206 to take decision either to remove the link or send a revised annex ZA for assessment at PUB

  • Standard
    26 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 10993-10:2023(Main)
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
EN ISO 10993-10:2023

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
—    details of in vivo skin sensitization test procedures;
—    key factors for the interpretation of the results.
NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

  • Standard
    60 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    59 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 10993-2:2023(Main)
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
EN ISO 10993-2:2022

This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.
This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.
This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.
This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.

  • Standard
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 10993-7:2009/A1:2022(Amendment)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
EN ISO 10993-7:2008/A1:2022

2021-12-09- JO-  the EN was submitted to FV wiith the link to the legislation (90/385/EEC, 93/42/EEC)
however since these legilsations have been repealed, the link has been removed and the EN is to proceed to publication

  • Amendment
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 20776-2:2022(Main)
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021)
EN ISO 20776-2:2022

This document establishes acceptable performance criteria for antimicrobial susceptibility test
(AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to
antimicrobial agents in medical laboratories.
This document specifies requirements for AST devices and procedures for assessing performance of
such devices. It defines how a performance evaluation of an AST device is to be conducted.
This document has been developed to guide manufacturers in the conduct of performance evaluation
studies.

  • Standard
    25 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 10993-9:2022(Main)
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
EN ISO 10993-9:2021

This document provides general principles for the systematic evaluation of the potential and observed
degradation of medical devices through the design and performance of in vitro degradation studies.
Information obtained from these studies can be used in the biological evaluation described in the
ISO 10993 series.
This document is applicable to both materials designed to degrade in the body as well as materials that
are not intended to degrade.
This document is not applicable to:
a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the
production of this type of degradation product are described in specific product standards, where
available;
NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from
the scope of this document, such degradation products can evoke a biological response and can undergo
biological evaluation as described in other parts of ISO 10993.
b) leachable components which are not degradation products;
c) medical devices or components that do not contact the patient's body directly or indirectly

  • Standard
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    20 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 10993-12:2021(Main)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
EN ISO 10993-12:2021

This document specifies requirements and gives guidance on the procedures in the preparation of
samples and the selection of reference materials for medical device testing primarily in biological test
systems primarily in accordance with one or more parts of the ISO 10993 series.
Specifically, this document addresses the following:
— test sample selection;
— selection of representative portions from a medical device;
— test sample preparation;
— experimental controls;
— selection of, and requirements for, reference materials;
— preparation of extracts.
This document is not applicable to live cells but can be relevant to the material or medical device
components of combination products containing live cells.
Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the
exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization.
Information given in C.1 to C.4 can also be relevant.

  • Standard
    32 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    32 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 10993-23:2021(Main)
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
EN ISO 10993-23:2021

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation by using an in vitro reconstructed human epidermis model.

  • Standard
    76 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    71 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 10993-1:2021(Main)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)
EN ISO 10993-1:2020

This document specifies:
— the general principles governing the biological evaluation of medical devices within a risk
management process;
— the general categorization of medical devices based on the nature and duration of their contact with
the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the medical
device;
— the assessment of the biological safety of the medical device.
This document applies to evaluation of materials and medical devices that are expected to have direct
or indirect contact with:
— the patient's body during intended use;
— the user’s body, if the medical device is intended for protection (e.g., surgical gloves, masks and
others).
This document is applicable to biological evaluation of all types of medical devices including active,
non-active, implantable and non-implantable medical devices.
This document also gives guidelines for the assessment of biological hazards arising from:
— risks, such as changes to the medical device over time, as a part of the overall biological safety
assessment;
— breakage of a medical device or medical device component which exposes body tissue to new or
novel materials.
Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Devicespecific
or product standards address mechanical testing.
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform
encephalopathy (TSE) agents and other pathogens.

  • Standard
    50 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    51 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 10993-18:2020(Main)
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
EN ISO 10993-18:2020

This document specifies a framework for the identification, and if necessary, quantification of
constituents of a medical device, allowing the identification of biological hazards and the estimation
and control of biological risks from material constituents, using a generally stepwise approach to the
chemical characterization which can include one or more of the following:
— the identification of its materials of construction (medical device configuration);
— the characterization of the materials of construction via the identification and quantification of
their chemical constituents (material composition);
— the characterization of the medical device for chemical substances that were introduced during
manufacturing (e.g. mould release agents, process contaminants, sterilization residues);
— the estimation (using laboratory extraction conditions) of the potential of the medical device,
or its materials of construction, to release chemical substances under clinical use conditions
(extractables);
— the measurement of chemical substances released from a medical device under its clinical conditions
of use (leachables).
This document can also be used for chemical characterization (e.g. the identification and/or
quantification) of degradation products. Information on other aspects of degradation assessment are
covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series is applicable when the material or medical device has direct or indirect body
contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support
a biological evaluation.

  • Standard
    81 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    69 pages
    English language
    sale 10% off
    e-Library read for
    1 day