EN ISO 10993-18:2009
(Main)Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
ISO 10993-18:2005 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example, as part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971), as a measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17), for judging equivalence of a proposed material to a clinically established material, for judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former, or for screening of potential new materials for suitability in a medical device for a proposed clinical application.
ISO 10993-18:2005 does not address the identification or quantification of degradation products, which is covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1).
ISO 10993-18:2005 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.
Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung von Werkstoffen (ISO 10993-18:2005)
Dieser Teil von ISO 10993 beschreibt einen Rahmen für die Identitätsbestimmung eines Werkstoffs und die
qualitative und quantitative Bestimmung seiner chemischen Bestandteile. Die so gewonnenen Angaben über
die chemische Charakterisierung können in einer Vielzahl wichtiger Anwendungen benutzt werden, zum
Beispiel:
⎯ als Teil der Beurteilung der allgemeinen biologischen Sicherheit eines Medizinprodukts (ISO 10993-1 und
ISO 14971);
⎯ bei der Bestimmung der Konzentration herauslösbarer Substanzen in einem Medizinprodukt, um die
Beurteilung der Einhaltung zulässiger Grenzwerte, die für die betreffende Substanz auf der Basis einer
gesundheitsbezogenen Risikobewertung ermittelt wurden (ISO 10993-17) zu ermöglichen;
⎯ bei der Beurteilung der Gleichwertigkeit eines vorgesehenen Werkstoffs mit einem klinisch eingeführten
Material;
⎯ bei der Beurteilung der Gleichwertigkeit eines Endprodukts mit dessen Prototyp, in dem die ermittelten
Daten des Endproduktes mit denen des Prototyps verglichen und überprüft werden;
⎯ bei der Screeninguntersuchung möglicher neuer Werkstoffe in Bezug auf deren Eignung für ein
Medizinprodukt hinsichtlich der vorgesehenen klinischen Anwendung.
Dieser Teil der ISO 10993 behandelt nicht den qualitativen oder quantitativen Nachweis von Abbauprodukten,
der durch ISO 10993-9, -13, -14 und -15 abgedeckt wird.
Die Normenreihe ISO 10993 ist anwendbar, wenn der Werkstoff oder das Produkt direkt oder indirekt mit dem
Körper in Kontakt kommt (siehe ISO 10993-1:2003, 4.2.1).
Die ISO 10993-18 ist für Werkstofflieferanten und Hersteller von Medizinprodukten vorgesehen, wenn diese
eine Beurteilung der biologischen Sicherheit vornehmen.
Évaluation biologique des dispositifs médicaux - Partie 18: Caractérisation chimique des matériaux (ISO 10993-18:2005)
L'ISO 10993-18:2005 décrit un cadre servant à l'identification d'un matériau et à la détermination et la quantification de ses composés chimiques. Les informations relatives à la caractérisation chimique obtenues peuvent servir à une large gamme d'applications importantes notamment, par exemple prendre part à l'évaluation de la sécurité biologique globale d'un dispositif médical (ISO 10993-1 et ISO 14971), mesurer le niveau de substances relargables dans un dispositif médical afin d'évaluer la conformité avec les limites admissibles pour cette substance dérivées d'une évaluation des risques relatifs à la santé (ISO 10993-17), juger de l'équivalence entre un matériau proposé et un matériau cliniquement établi, juger de l'équivalence d'un dispositif final à un prototype pour vérifier la pertinence des données relatives au prototype utilisées pour l'évaluation dudit dispositif; sélectionner les nouveaux matériaux potentiels afin de déterminer le caractère adéquat de ceux-ci au sein d'un dispositif médical pour une application clinique proposée.
L'ISO 10993-18:2005 ne traite pas de l'identification ou de la quantification des produits de dégradation qui sont abordés dans l'ISO 10993-9, l'ISO 10993-13, l'ISO 10993-14 et l'ISO 10993-15.
Les normes de la série ISO 10993 s'appliquent en cas de contact direct ou indirect entre le matériau ou le dispositif et le corps (voir l'ISO 10993-1, 4.2.1).
L'ISO 10993-18:2005 s'adresse aux fournisseurs de matériaux et aux fabricants de dispositifs médicaux pour la conduite d'une évaluation de la sécurité biologique.
Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev lastnosti materialov (ISO 10993-18:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 10993-18:2005
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Biological evaluation of medical devices - Part 18: Chemical characterization of materials
(ISO 10993-18:2005)
Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung
von Werkstoffen (ISO 10993-18:2005)
Evaluation biologique des dispositifs médicaux - Partie 18 : Caractérisation chimique des
matériaux (ISO 10993-18:2005)
Ta slovenski standard je istoveten z: EN ISO 10993-18:2009
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 10993-18
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.100.20 Supersedes EN ISO 10993-18:2005
English Version
Biological evaluation of medical devices - Part 18: Chemical
characterization of materials (ISO 10993-18:2005)
Évaluation biologique des dispositifs médicaux - Partie 18: Biologische Beurteilung von Medizinprodukten - Teil 18:
Caractérisation chimique des matériaux (ISO 10993- Chemische Charakterisierung von Werkstoffen (ISO 10993-
18:2005) 18:2005)
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 10993-18:2009: 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 10993-18:2005 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 10993-18:2009 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 10993-18:2005.
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 10993-18:2005 has been approved by CEN as a EN ISO 10993-18:2009 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
5, 6, 7, 8 & Annex A
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
5, 6, 7, 8, & Annex A
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 10993-18
First edition
2005-07-01
Biological evaluation of medical
devices —
Part 18:
Chemical characterization of materials
Évaluation biologique des dispositifs médicaux —
Partie 18: Caractérisation chimique des matériaux
Reference number
ISO 10993-18:2005(E)
©
ISO 2005
ISO 10993-18:2005(E)
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ISO 10993-18:2005(E)
Contents Page
Foreword. iv
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Symbols and abbreviated terms . 3
5 General principles. 3
6 Characterization procedure . 4
6.1 General. 4
6.2 Step 1 — Qualitative information . 5
6.3 Step 2 — Material equivalence . 5
6.4 Step 3 — Quantitative information. 5
6.5 Step 4 — Quantitative risk assessment. 5
6.6 Step 5 — Estimated clinical exposure to chemicals present. 6
7 Chemical characterization parameters and methods . 6
7.1 General. 6
7.2 Polymers. 7
7.3 Metals and alloys . 8
7.4 Ceramics. 8
7.5 Natural macromolecules . 9
8 Reporting of data obtained . 10
Annex A (normative) Flowchart summarizing the stepwise generation of chemical
characterization data for use in toxicological risk assessment . 11
Annex B (informative) Information sources for chemical characterization . 13
Annex C (informative) Principles for judging toxicological equivalency . 16
Bibliography . 17
ISO 10993-18:2005(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 collabo
...
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