EN ISO 10993-11:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische Toxizität (ISO 10993-11:2006)Évaluation biologique des dispositifs médicaux - Partie 11 : Essais de toxicité systémique (ISO 10993-11:2006)Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)11.100.20Biological evaluation of medical devicesICS:Ta slovenski standard je istoveten z:EN ISO 10993-11:2009SIST EN ISO 10993-11:2009en01-julij-2009SIST EN ISO 10993-11:2009SLOVENSKI
STANDARDSIST EN ISO 10993-11:20061DGRPHãþD

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 10993-11April 2009ICS 11.100.20Supersedes EN ISO 10993-11:2006
English VersionBiological evaluation of medical devices - Part 11: Tests forsystemic toxicity (ISO 10993-11:2006)Évaluation biologique des dispositifs médicaux - Partie 11:Essais de toxicité systémique (ISO 10993-11:2006)Biologische Beurteilung von Medizinprodukten - Teil 11:Prüfungen auf systemische Toxizität (ISO 10993-11:2006)This European Standard was approved by CEN on 12 April 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10993-11:2009: ESIST EN ISO 10993-11:2009

Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices . Error! Bookmark not defined.Annex ZB (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 90/385/EEC on Active Implantable Medical Devices .5 SIST EN ISO 10993-11:2009

Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA — Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4, 5, 6
Annex I: 7.1, 7.2, 7.5
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 90/385/EEC on Active Implantable Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZB confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZB — Correspondence between this European Standard and Directive 90/385/EEC on active implantable medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/Notes 4, 5, 6 Annex I : 9
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
Reference numberISO 10993-11:2006(E)© ISO 2006
INTERNATIONAL STANDARD ISO10993-11Second edition2006-08-15Biological evaluation of medical devices — Part 11: Tests for systemic toxicity Évaluation biologique des dispositifs médicaux — Partie 11: Essais de toxicité systémique
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ISO 10993-11:2006(E) © ISO 2006 – All rights reserved iiiContents Page Foreword.iv Introduction.vi 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 General considerations.2 4.1 General.2 4.2 Selection of animal species.3 4.3 Animal status.3 4.4 Animal care and husbandry.3 4.5 Size and number of groups.3 4.6 Route of exposure.4 4.7 Sample preparation.4 4.8 Dosing.5 4.9 Body weight and food/water consumption.6 4.10 Clinical observations.6 4.11 Clinical pathology.6 4.12 Anatomic pathology.7 4.13 Study designs.7 4.14 Quality of investigation.7 5 Acute systemic toxicity.7 5.1 General.7 5.2 Study design.8 5.3 Evaluation criteria.9 5.4 Final report.10 6 Repeated exposure systemic toxicity (subacute, subchronic and chronic systemic toxicity).11 6.1 General.11 6.2 Study design.12 6.3 Evaluation criteria.14 6.4 Final report.15 Annex A (informative)
Routes of administration.16 Annex B (informative)
Dosage volumes.18 Annex C (informative)
Common clinical signs and observations.19 Annex D (informative)
Suggested haematology, clinical chemistry and urinalysis measurements.20 Annex E (informative)
Suggested organ list for histopathological evaluation.22 Annex F (informative)
Information on material-mediated pyrogens.24 Bibliography.
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