EN ISO 10993-17:2009
(Main)Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
ISO 10993-17:2002 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.
ISO 10993-17:2002 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).
Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. ISO 10993-17:2002 does not address the potential for exposure from such sources.
Biologische Beurteilung von Medizinprodukten - Teil 17: Nachweis zulässiger Grenzwerte für herauslösbare Bestandteile (ISO 10993-17:2002)
Dieser Teil der ISO 10993 legt das Verfahren zur Bestimmung zulässiger Grenzwerte für herauslösbare
Bestandteile aus Medizinprodukten fest. Er ist für die Anwendung bei der Erstellung von Normen vorgesehen
sowie für die Abschätzung geeigneter Grenzwerte in den Fällen, in denen keine Normen vorliegen. Er
beschreibt einen systematischen Prozess, mit dem festgestellte Risiken durch toxikologisch gefährliche
Substanzen, die in Medizinprodukten enthalten sind, quantitativ bestimmt werden können.
Dieser Teil der ISO 10993 ist nicht anwendbar für Produkte, die nicht mit dem Patienten in Kontakt kommen
(z. B. Geräte für die in vitro-Diagnostik).
Die Exposition einer besonderen chemischen Substanz kann aus anderen Ursachen hervorgehen, z. B.
Lebensmittel, Wasser und Luft. Dieser Teil der ISO 10993 behandelt nicht die mögliche Exposition durch
diese Quellen.
Évaluation biologique des dispositifs médicaux - Partie 17: Établissement des limites admissibles des substances relargables (ISO 10993-17:2002)
L'ISO 10993-17 définit la méthode à mettre en oeuvre afin de déterminer des limites admissibles pour les substances relargables dans des dispositifs médicaux. Elle est destinée à servir à l'élaboration d'autres normes et à évaluer des limites appropriées là où il n'existe pas de norme. Elle décrit un procédé systématique grâce auquel des risques identifiés liés à des substances toxiques dangereuses dans les dispositifs médicaux peuvent être quantifiés.
L'ISO 10993-17 ne s'applique pas aux dispositifs avec lesquels les patients ne sont pas en contact (équipements pour diagnostics in vitro, par exemple).
Il est possible d'être exposé à une substance chimique particulière provenant d'autres sources, comme la nourriture, l'eau et l'air. L'ISO 10993-17 ne traite pas de l'éventualité d'une exposition à de telles sources.
Biološko ovrednotenje medicinskih pripomočkov - 17. del: Postavitev dopustnih mej za izlužene snovi (ISO 10993-17:2002)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 10993-17:2003
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO 3RVWDYLWHYGRSXVWQLK
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Biological evaluation of medical devices - Part 17: Establishment of allowable limits for
leachable substances (ISO 10993-17:2002)
Biologische Beurteilung von Medizinprodukten - Teil 17: Nachweis zulässiger
Grenzwerte für herauslösbare Bestandteile (ISO 10993-17:2002)
Evaluation biologique des dispositifs médicaux - Partie 17 : Établissement des limites
admissibles des substances relargables (ISO 10993-17:2002)
Ta slovenski standard je istoveten z: EN ISO 10993-17:2009
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 10993-17
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.100.20 Supersedes EN ISO 10993-17:2002
English Version
Biological evaluation of medical devices - Part 17: Establishment
of allowable limits for leachable substances (ISO 10993-
17:2002)
Évaluation biologique des dispositifs médicaux - Partie 17: Biologische Beurteilung von Medizinprodukten - Teil 17:
Établissement des limites admissibles des substances Nachweis zulässiger Grenzwerte für herauslösbare
relargables (ISO 10993-17:2002) Bestandteile (ISO 10993-17:2002)
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 European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards 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 translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official 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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-17:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .5
Foreword
The text of ISO 10993-17:2002 has been prepared by Technical Committee ISO/TC 194 “Biological evaluation
of medical devices” of the International Organization for Standardization (ISO) and has been taken over as EN
ISO 10993-17:2009 by Technical Committee CEN/TC 206 “Biological evaluation of medical devices” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10993-17:2002.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directives 93/42/EEC on
Medical Devices and 90/385/EEC on Active Implantable Medical Devices.
For relationship with the EU Directives, see informative Annexes ZA and ZB, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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 the United Kingdom.
Endorsement notice
The text of ISO 10993-17:2002 has been approved by CEN as a EN ISO 10993-17:2009 without any
modification.
Annex ZA
(informative)
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 Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
4, 5, 6, 7, 8, 9, 10
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.
Annex ZB
(informative)
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 Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 90/385/EEC
4, 5, 6, 7, 8, 9, 10
Annex I :
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 10993-17
First edition
2002-12-01
Biological evaluation of medical devices —
Part 17:
Establishment of allowable limits for
leachable substances
Évaluation biologique des dispositifs médicaux —
Partie 17: Établissement des limites admissibles des substances
relargables
Reference number
ISO 10993-17:2002(E)
©
ISO 2002
ISO 10993-17:2002(E)
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ISO 10993-17:2002(E)
Contents Page
Foreword . iv
Introduction. vi
1 Scope. 1
2 Normative reference. 1
3 Terms and definitions. 1
4 General principles for establishing allowable limits . 4
5 Establishment of tolerable intake (TI) for specific leachable substances . 5
5.1 General. 5
5.2 Exposure considerations for TI calculation . 7
5.3 Collection and evaluation of data. 7
5.4 Set TI for noncancer endpoints . 8
5.5 Set TI for cancer endpoints. 10
5.6 Establishment of tolerable contact levels (TCLs). 11
5.7 Risk assessment of mixtures. 13
6 Calculation of tolerable exposure (TE) . 13
6.1 General. 13
6.2 Exposure population. 14
6.3 Calculation of utilization factor from intended use pattern. 14
6.4 Tolerable exposure. 15
7 Feasibility evaluation. 16
8 Benefit evaluation. 16
9 Allowable limits. 17
10 Reporting requirements. 17
Annex A (informative) Some typical assumptions for biological parameters. 18
Annex B (informative) Risk assessment for mixtures of leachable substances. 20
Annex C (informative) Conversion of allowable limits for systemic exposure and for body surface
contact to maximum dose to patient from a medical device. 21
Annex D (informative) Risk analysis report . 23
Bibliography.
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