EN ISO 10993-18:2005

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

This document describes a framework for the identification and, where necessary, quantification of the chemical constituents of a material to provide information required for inclusion in an assessment of the biological safety of medical devices. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993 part 9, 13, 14 and 15. ISO 10993-18 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, 4.2.1).
Die ISO 10993-18 ist für Werkstofflieferanten und Hersteller von Medizinprodukten vorgesehen, wenn diese eine Beurteilung der biologischen Sicherheit vornehmen.

Evaluation biologique des dispositifs médicaux - Partie 18: Caractérisation chimique des matériaux (ISO 10993-18:2005)

Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev lastnosti materialov (ISO 10993-18:2005)

General Information

• Status: Withdrawn
• Publication Date: 30-Jun-2005
• Withdrawal Date: 28-Apr-2009
• ICS: 11.100 - Laboratory medicine
• Technical Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Drafting Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 29-Apr-2009
• Completion Date: 29-Apr-2009
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 10993-18:2005 - Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

Relations

• Replaced By: EN ISO 10993-18:2009 - Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2005
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO.HPLþQDRSUHGHOLWHY
ODVWQRVWLPDWHULDORY,62
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 10993-18:2005
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
July 2005
ICS 11.100.20
English Version
Biological evaluation of medical devices - Part 18: Chemical
characterization of materials (ISO 10993-18:2005)
Evaluation biologique des dispositifs médicaux - Partie 18: Biologische Beurteilung von Medizinprodukten - Teil 18:
Caractérisation chimique des matériaux (ISO 10993- Chemische Charakterisierung von Werkstoffen (ISO
18:2005) 10993-18:2005)
This European Standard was approved by CEN on 6 June 2005.

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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-18:2005: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 10993-18:2005) has been prepared by Technical Committee CEN/TC
206 "Biocompatibility of medical and dental materials and devices", the secretariat of which is
held by NEN, in collaboration with Technical Committee ISO/TC 194 "Biological evaluation of
medical devices".
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 January 2006, and conflicting national
standards shall be withdrawn at the latest by January 2006.

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 ZA, 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,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 10993-18:2005 has been approved by CEN as EN ISO 10993-18:2005 without
any modifications.
ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC

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.

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 normative 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.
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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ii © ISO 2005 – All rights reserved

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 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 2.
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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10993-18 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 9: Framework for identification and quantification of potential degradation products
 Part 10: Tests for irritation and delayed-type hypersensitivity
 Part 11: Tests for systemic toxicity
 Part 12: Sample preparation and reference materials
 Part 13: Identification and quantification of degradation products from polymeric medical devices
 Part 14: Identification and quantification of degradation products from ceramics
 Part 15: Identification and quantification of degradation products from metals and alloys
 Part 16: Toxicokinetic study design for degradation products and leachables
 Part 17: Establishment of allowable limits for leachable substances
iv © ISO 2005 – All rights reserved

ISO 10993-18:2005(E)
 Part 18: Chemical characterization of materials
The following parts are under preparation:
 Part 19: Physico-chemical, mechanical and morphological characterization
 Part 20: Principles and methods for immunotoxicology testing of medical devices
Future parts will deal with other relevant aspects of biological testing.
For the purposes of this part of ISO 10993, the CEN annex regarding fulfilment of European Council
Directives has been removed.
ISO 10993-18:2005(E)
Introduction
ISO 10993-1 provides a framework for a structured programme of assessment for the evaluation of biological
safety. Clause 3 of ISO 10993-1:2003 states that in the selection of materials to be used for device
manufacture the first consideration should be fitness for purpose. This should have regard to the
characteristics and properties of the material, which include chemical, toxicological, physical, electrical,
morphological and mechanical properties. This information is necessary prior to any biological evaluati
...