SIST EN ISO 10993-17:2003

SLOVENSKI STANDARD
01-marec-2003
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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: Etablissement des limites
admissibles des substances relargables (ISO 10993-17:2002)
Ta slovenski standard je istoveten z: EN ISO 10993-17:2002
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
December 2002
ICS 11.100
English version
Biological evaluation of medical devices - Part 17: Establishment
of allowable limits for leachable substances (ISO 10993-
17:2002)
Evaluation biologique des dispositifs médicaux - Partie 17: Biologische Beurteilung von Medizinprodukten - Teil 17:
Etablissement 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 9 October 2002.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
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© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-17:2002 E
worldwide for CEN national Members.

CORRECTED  2003-03-26
Foreword
This document (EN ISO 10993-17:2002) has been prepared by Technical Committee ISO/TC
194 "Biological evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 "Biocompatibility of medical and dental materials and 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 June 2003, and conflicting national
standards shall be withdrawn at the latest by June 2003.
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
Directive(s).
For relationship with EU Directive(s), see informative Annex 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, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10993-17:2002 has been approved by CEN as EN ISO 10993-17:2002 without
any modifications.
NOTE Normative references to International Standards are listed in annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 10993-1 1997 Biological evaluation of medical EN ISO 10993-1 1997
devices - Part 1: Evaluation and
testing
Annex ZB
(informative)
Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives
This European Standard 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 Directive 93/42/EEC.
WARNING Other requirements and other EU Directives may be applicable to the
product(s) falling within the scope of this standard.
The following clauses of this standard are likely to support requirements of Directive 93/42/EEC.
Compliance with these clauses of this standard provides one means of conforming with the
specific essential requirements of the Directive concerned and associated EFTA regulations.
Table ZA.1— Correspondence between this European Standard and EU Directives
Clause/subclause of this Corresponding Essential Comments
European Standard Requirement of Directive
93/42/EEC
4, 5, 6, 7, 8, 9 93/42/EWG:
Annex I: 1, 2, 6, 7.1, 7.2, 7.3, 7.5
4, 5, 6, 7, 8, 9 90/385/EWG:
Annex I: 1, 3, 5, 8, 9
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. 24

ISO 10993-17:2002(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
The main task of technical committees is to prepare International Standards. Draft International Standards adopted
by the technical committees are circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this part of ISO 10993 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10993-17 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.
ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices:
 Part 1: Evaluation and testing
 Part 2: Animal welfare requirements
 Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
 Part 4: Selection of tests for interactions with blood
 Part 5: Tests for in vitro cytotoxicity
 Part 6: Tests for local effects after implantation
 Part 7: Ethylene oxide sterilization residuals
 Part 8: Selection and qualification of reference materials for biological tests
 Part 9: Framework for identification and quantification of potential degradation products
 Part 10: Tests for irrit
...