SIST EN ISO 10993-13:2009
(Main)Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)
This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. This part of ISO 10993 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test. For materials which are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation. The biological activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, but should be evaluated according to the principles of ISO 10993-1 and ISO 14538. Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques are identified or given preference. No specific requirements for acceptable levels of degradation products are provided in this part of ISO 10993.
Biologische Beurteilung von Medizinprodukten - Teil 13: Qualitativer und quantitativer Nachweis von Abbauprodukten in Medizinprodukten aus Polymeren (ISO 10993-13:1998)
Dieser Teil von ISO 10993 gibt eine Anleitung für die allgemeinen Anforderungen an den Entwurf und an die
Auslegung von Prüfungen zur Identifizierung und Quantifizierung von Abbauprodukten aus fertig bearbeiteten
Medizinprodukten aus Polymeren, so wie sie in der Klinik zur Anwendung kommen.
Dieser Teil von ISO 10993 beschreibt zwei Prüfmethoden zur Erzeugung von Abbauprodukten, eine
beschleunigte Abbauprüfung als Screeningmethode und eine Echtzeitabbauprüfung. Für Materialien, die dafür
gedacht sind, in situ zu polymerisieren, wird für die Prüfung das abgebundene oder ausgehärtete Polymer
verwendet. Die erhaltenen Daten dienen zur biologischen Beurteilung der Polymere.
Dieser Teil von ISO 10993 beschreibt nur die Abbauprodukte, die durch eine chemische Veränderung des
fertigen Polymerproduktes erzeugt werden. Er ist nicht anwendbar auf jenen Abbau von Medizinprodukten,
der während der vorgesehenen Anwendung durch mechanische Belastungen, durch Abrieb oder durch
elektromagnetische Strahlung entsteht.
Die biologische Aktivität der Bruchstücke und der löslichen Abbauprodukte wird in diesem Teil von ISO 10993
nicht behandelt, sie soll aber nach den Prinzipien von ISO 10993-1 und ISO 14538 bewertet werden.
Aufgrund des großen Anwendungsbereiches von Polymeren in Medizinprodukten wird keine spezielle
Analysentechnik angegeben oder bevorzugt. In diesem Teil von ISO 10993 werden auch keine spezifischen
Forderungen an zulässige Gehalte von Abbauprodukten angegeben.
Evaluation biologique des dispositifs médicaux - Partie 13 : Identification et quantification de produits de dégradation de dispositifs médicaux à base de polymères (ISO 10993-13:1998)
L'IEC 61800-9-2:2017 spécifie les indicateurs d'efficacité énergétique pour l'électronique de puissance (modules d'entraînement complets, CDM), les entraînements électriques de puissance (PDS) et les démarreurs de moteurs, utilisés avec les équipements entraînés par moteur.
Elle spécifie la méthodologie de détermination des pertes du module d'entraînement complet (CDM), de l'entraînement électrique de puissance (PDS) et du système moteur.
Elle définit les classes IE et IES et établit leurs valeurs limites, ainsi que les procédures d'essai pour le classement des pertes globales du système moteur.
Le présent document propose également une méthodologie pour la mise en œuvre de la meilleure solution écoénergétique des entraînements électriques. Cela dépend de l'architecture du système entraîné par moteur, du profil vitesse/charge et des points de fonctionnement dans le temps de l’équipement entraîné.
Biološko ovrednotenje medicinskih pripomočkov - 13. del: Prepoznavanje in ugotavljanje količine razgradnih produktov polimerov, iz katerih so izdelani medicinski pripomočki (ISO 10993-13:1998)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10993-13:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 10993-13:2000
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Biological evaluation of medical devices - Part 13: Identification and quantification of
degradation products from polymeric medical devices (ISO 10993-13:1998)
Biologische Beurteilung von Medizinprodukten - Teil 13: Qualitativer und quantitativer
Nachweis von Abbauprodukten in Medizinprodukten aus Polymeren (ISO 10993-
13:1998)
Evaluation biologique des dispositifs médicaux - Partie 13 : Identification et quantification
de produits de dégradation de dispositifs médicaux à base de polymères (ISO 10993-
13:1998)
Ta slovenski standard je istoveten z: EN ISO 10993-13:2009
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-13:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10993-13:2009
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SIST EN ISO 10993-13:2009
EUROPEAN STANDARD
EN ISO 10993-13
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.100.20 Supersedes EN ISO 10993-13:1998
English Version
Biological evaluation of medical devices - Part 13: Identification
and quantification of degradation products from polymeric
medical devices (ISO 10993-13:1998)
Évaluation biologique des dispositifs médicaux - Partie 13: Biologische Beurteilung von Medizinprodukten - Teil 13:
Identification et quantification de produits de dégradation Qualitativer und quantitativer Nachweis von
de dispositifs médicaux à base de polymères (ISO 10993- Abbauprodukten in Medizinprodukten aus Polymeren (ISO
13:1998) 10993-13:1998)
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 10993-13:2009: E
worldwide for CEN national Members.
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SIST EN ISO 10993-13:2009
EN ISO 10993-13:2009 (E)
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
2
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SIST EN ISO 10993-13:2009
EN ISO 10993-13:2009 (E)
Foreword
The text of ISO 10993-13:1998 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 10993-13:2009 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 10993-13:1998.
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 10993-13:1998 has been approved by CEN as a EN ISO 10993-13:2009 without any
modification.
3
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SIST EN ISO 10993-13:2009
EN ISO 10993-13:2009 (E)
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
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.
4
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SIST EN ISO 10993-13:2009
EN ISO 10993-13:2009 (E)
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
Annex I :
9
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
5
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SIST EN ISO 10993-13:2009
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SIST EN ISO 10993-13:2009
INTERNATIONAL ISO
STANDARD 10993-13
First edition
1998-11-15
Biological evaluation of medical devices —
Part 13:
Identification and quantification of degradation
products from polymeric medical devices
Évaluation biologique des dispositifs médicaux —
Partie 13: Identification et quantification de produits de dégradation de
dispositifs médicaux à base de polymères
A
Reference number
ISO 10993-13:1998(E)
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SIST EN ISO 10993-13:2009
ISO 10993-13:1998(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Definitions . 2
4 Degradation test methods . 2
4.1 General procedures. 2
4.2 Accelerated degradation test . 5
4.3 Real-time degradation test. 5
5 Test procedures. 6
5.1 Initial material characterization . 7
5.2 Accelerated degradation test . 7
5.3 Real-time degradation test.8
6 Test report .9
Annex A Analytical methods .10
© ISO 1998
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
ii
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SIST EN ISO 10993-13:2009
©
ISO ISO 10993-13:1998(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.
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.
International Standard ISO 10993-13 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 cytotoxicity: in vitro methods
— Part 6: Tests for local effects after implantation
— Part 7: Ethylene oxide sterilization residuals
— Part 9: Framework for the identification and quantification of potential
degradation products
— Part 10: Tests for irritation and sensitization
— 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
iii
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SIST EN ISO 10993-13:2009
©
ISO 10993-13:1998(E) ISO
— 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
Annex A of this part of ISO 10993 is for information only.
iv
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SIST EN ISO 10993-13:2009
©
ISO ISO 10993-13:1998(E)
Introduction
This part of ISO 10993 was developed from ISO/TR 10993-9. Degradation
products covered by this standard are formed primarily by chemical bond
scission due to hydrolytic and/or oxidative processes in an aqueous
environment. It is recognized that additional biological factors, such as
enzymes, other proteins and cellular activity, can alter the rate and nature
of degradation.
It should be kept in mind that a polymeric device may contain residuals and
leachables such as monomers, oligomers, solvents, catalysts, additives,
fillers and processing aids. These components which, if present, may
interfere with the identification and quantification of the degradation
products, need to be considered and accounted for. It should be
recognized that residual monomers may generate the same degradation
products as the polymer itself.
The identified and quantified degradation products form the basis for
biological evaluation in accordance with ISO 10993-1, for risk assessment
in accordance with ISO 14538 and, if appropriate, for toxicokinetic studies
in accordance with ISO 10993-16.
v
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SIST EN ISO 10993-13:2009
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SIST EN ISO 10993-13:2009
INTERNATIONAL STANDARD © ISO ISO 10993-13:1998(E)
Biological evaluation of medical devices —
Part 13:
Identification and quantification of degradation products from polymeric
medical devices
1 Scope
This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and
quantifying degradation products from finished polymeric medical devices ready for clinical use.
This part of ISO 10993 describes two test methods to generate degradation products, an accelerated degradation
test as a screening method and a real-time degradation test. For materials which are intended to polymerize in situ,
the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer.
This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finished
polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical
stress, wear or electromagnetic radiation.
The biological activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, but
should be evaluated according to the principles of ISO 10993-1 and ISO 14538.
Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques are
identified or given preference. No specific requirements for acceptable levels of degradation products are provided
in this part of ISO 10993.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this part of
ISO 10993. At the time of publication, the editions indicated were valid. All standards are subject to revision, and
parties to agreements based on this part of ISO 10993 are encouraged to investigate the possibility of applying the
most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid
International Standards.
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods.
ISO 10993-1:1997, Biological evaluation of medical devices — Part 1: Evaluation and testing.
1)
ISO 10993-9:— , Biological evaluation of medical devices — Part 9: Framework for identification and quantification
of potential degradation products.
ISO 10993-12:1996, Biological evaluation of medical devices — Part 12: Sample preparation and reference
materials.
1)
To be published.
1
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SIST EN ISO 10993-13:2009
© ISO
ISO 10993-13:1998(E)
ISO 10993-16:1997, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation
products and leachables.
ISO 13781:1997, Poly(L-lactide) resins and fabricated forms for surgical implants — In vitro degradation testing.
1)
ISO 14538:— Biological evaluation of medical devices — Establishment of permissible limits for sterilization and
process residues using health-based risk assessment.
3 Definitions
For the purposes of this part of ISO 10993, the definitions given in ISO 10993-1, ISO 10993-9, ISO 13781 and the
following definitions apply.
3.1 residual monomer
unreacted chemical compound(s) used to build the polymeric chains and still present in the final polymeric material
3.2 degradation product
chemical compound derived from the breakdown of the polymeric material, including any compound produced by
consecutive chemical reactions
3.3 polymeric material
materials consisting of long-chain and/or crosslinked molecules composed of units called monomers
3.4 hydrolytic degradation
scission of chemical bonds in a polymer by the attack of water
NOTE The water may have a neutral, acidic or alkaline pH value and may contain additional chemical compounds or ions.
3.5 oxidative degradation
scission of chemical bonds in a polymer by the attack of oxidizing agent(s)
3.6 debris
particulate material produced by the degradation of a polymeric material
4 Degradation test methods
4.1 General procedures
4.1.1 Test design
In accordance with ISO 10993-9, degradation tests shall be used to generate
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biologische Beurteilung von Medizinprodukten - Teil 13: Qualitativer und quantitativer Nachweis von Abbauprodukten in Medizinprodukten aus Polymeren (ISO 10993-13:1998)Evaluation biologique des dispositifs médicaux - Partie 13 : Identification et quantification de produits de dégradation de dispositifs médicaux à base de polymères (ISO 10993-13:1998)Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)11.100.20Biological evaluation of medical devicesICS:Ta slovenski standard je istoveten z:prEN ISO 10993-13kSIST prEN ISO 10993-13:2009en01-marec-2009kSIST prEN ISO 10993-13:2009SLOVENSKI
STANDARD
kSIST prEN ISO 10993-13:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN ISO 10993-13December 2008ICS 11.100.20Will supersede EN ISO 10993-13:1998
English VersionBiological evaluation of medical devices - Part 13: Identificationand quantification of degradation products from polymericmedical devices (ISO 10993-13:1998)Evaluation biologique des dispositifs médicaux - Partie 13:Identification et quantification de produits de dégradationde dispositifs médicaux à base de polymères (ISO 10993-13:1998)Biologische Beurteilung von Medizinprodukten - Teil 13:Qualitativer und quantitativer Nachweis vonAbbauprodukten in Medizinprodukten aus Polymeren (ISO10993-13:1998)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 206.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame 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.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 10993-13:2008: EkSIST prEN ISO 10993-13:2009
prEN ISO 10993-13:2008 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices .4Annex ZB (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 90/385/EEC on Active Implantable Medical Devices .5 kSIST prEN ISO 10993-13:2009
prEN ISO 10993-13:2008 (E) 3 Foreword The text of ISO 10993-13:1998 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 prEN ISO 10993-13:2008 by Technical Committee CEN/TC 206 “Biological evaluation of medical devices” the secretariat of which is held by NEN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 10993-13:1998. 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. Endorsement notice The text of ISO 10993-13:1998 has been approved by CEN as a prEN ISO 10993-13:2008 without any modification. kSIST prEN ISO 10993-13:2009
prEN ISO 10993-13:2008 (E) 4 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 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.
kSIST prEN ISO 10993-13:2009
prEN ISO 10993-13:2008 (E) 5 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 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.
kSIST prEN ISO 10993-13:2009
kSIST prEN ISO 10993-13:2009
AReference numberISO 10993-13:1998(E)INTERNATIONALSTANDARDISO10993-13First edition1998-11-15Biological evaluation of medical devices —Part 13:Identification and quantification of degradationproducts from polymeric medical devicesÉvaluation biologique des dispositifs médicaux —Partie 13: Identification et quantification de produits de dégradation dedispositifs médicaux à base de polymèreskSIST prEN ISO 10993-13:2009
ISO 10993-13:1998(E)©
ISO 1998All rights reserved. Unless otherwise specified, no part of this publication may be reproducedor utilized in any form or by any means, electronic or mechanical, including photocopying andmicrofilm, without permission in writing from the publisher.International Organization for StandardizationCase postale 56 · CH-1211 Genève 20 · SwitzerlandInternetiso@iso.chPrinted in SwitzerlandiiContentsPage1 Scope.12 Normative references.13 Definitions.24 Degradation test methods.24.1 General procedures.24.2 Accelerated degradation test.54.3 Real-time degradation test.55 Test procedures.65.1 Initial material characterization.75.2 Accelerated degradation test.75.3 Real-time degradation test.86 Test report.9Annex A
Analytical methods.10kSIST prEN ISO 10993-13:2009
© ISOISO 10993-13:1998(E)iiiForewordISO (the International Organization for Standardization) is a worldwidefederation of national standards bodies (ISO member bodies). The work ofpreparing International Standards is normally carried out through ISOtechnical committees. Each member body interested in a subject for whicha technical committee has been established has the right to be representedon that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISOcollaborates closely with the International Electrotechnical Commission(IEC) on all matters of electrotechnical standardization.Draft International Standards adopted by the technical committees arecirculated to the member bodies for voting. Publication as an InternationalStandard requires approval by at least 75 % of the member bodies castinga vote.International Standard ISO 10993-13 was prepared by TechnicalCommittee ISO/TC 194, Biological evaluation of medical devices.ISO 10993 consists of the following parts, under the general title Biologicalevaluation of medical devices:—Part 1: Evaluation and testing—Part 2: Animal welfare requirements—Part 3: Tests for genotoxicity, carcinogenicity and reproductivetoxicity—Part 4: Selection of tests for interactions with blood—Part 5: Tests for cytotoxicity: in vitro methods—Part 6: Tests for local effects after implantation—Part 7: Ethylene oxide sterilization residuals—Part 9: Framework for the identification and quantification of potentialdegradation products—Part 10: Tests for irritation and sensitization—Part 11: Tests for systemic toxicity—Part 12: Sample preparation and reference materials—Part 13: Identification and quantification of degradation products frompolymeric medical deviceskSIST prEN ISO 10993-13:2009
ISO 10993-13:1998(E)© ISOiv—Part 14: Identification and quantification of degradation products fromceramics—Part 15: Identification and quantification of degradation products frommetals and alloys—Part 16: Toxicokinetic study design for degradation products andleachablesAnnex A of this part of ISO 10993 is for information only.kSIST prEN ISO 10993-13:2009
© ISOISO 10993-13:1998(E)vIntroductionThis part of ISO 10993 was developed from ISO/TR 10993-9. Degradationproducts covered by this standard are formed primarily by chemical bondscission due to hydrolytic and/or oxidative processes in an aqueousenvironment. It is recognized that additional biological factors, such asenzymes, other proteins and cellular activity, can alter the rate and natureof degradation.It should be kept in mind that a polymeric device may contain residuals andleachables such as monomers, oligomers, solvents, catalysts, additives,fillers and processing aids. These components which, if present, mayinterfere with the identification and quantification of the degradationproducts, need to be considered and accounted for. It should berecognized that residual monomers may generate the same degradationproducts as the polymer itself.The identified and quantified degradation products form the basis forbiological evaluation in accordance with ISO 10993-1, for risk assessmentin accordance with ISO 14538 and, if appropriate, for toxicokinetic studiesin accordance with ISO 10993-16.kSIST prEN ISO 10993-13:2009
kSIST prEN ISO 10993-13:2009
INTERNATIONAL STANDARD
© ISOISO 10993-13:1998(E)1Biological evaluation of medical devices —Part 13:Identification and quantification of degradation products from polymericmedical devices1 ScopeThis part of ISO 10993 provides guidance on general requirements for the design of tests for identifying andquantifying degradation products from finished polymeric medical devices ready for clinical use.This part of ISO 10993 describes two test methods to generate degradation products, an accelerated degradationtest as a screening method and a real-time degradation test. For materials which are intended to polymerize in situ,the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer.This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finishedpolymeric device. It is not applicable to degradation of the device induced during its intended use by mechanicalstress, wear or electromagnetic radiation.The biological activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, butshould be evaluated according to the principles of ISO 10993-1 and ISO 14538.Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques areidentified or given preference. No specific requirements for acceptable levels of degradation products are providedin this part of ISO 10993.2 Normative referencesThe following standards contain provisions which, through reference in this text, constitute provisions of this part ofISO 10993. At the time of publication, the editions indicated were valid. All standards are subject to revision, andparties to agreements based on this part of ISO 10993 are encouraged to investigate the possibility of applying themost recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently validInternational Standards.ISO 3696:1987, Water for analytical laboratory use — Specification and test methods.ISO 10993-1:1997, Biological evaluation of medical devices — Part 1: Evaluation and testing.ISO 10993-9:—1), Biological evaluation of medical devices — Part 9: Framework for identification and quantificationof potential degradation products.ISO 10993-12:1996, Biological evaluation of medical devices — Part 12: Sample preparation and referencematerials.
1) To be published.kSIST prEN ISO 10993-13:2009
ISO 10993-13:1998(E)© ISO2ISO 10993-16:1997, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradationproducts and leachables.ISO 13781:1997, Poly(L-lactide) resins and fabricated forms for surgical implants — In vitro degradation testing.ISO 14538:—1) Biological evaluation of medical devices — Establishment of permissible limits for sterilization andprocess residues using health-based risk assessment.3 DefinitionsFor the purposes of this part of ISO 10993, the definitions given in ISO 10993-1, ISO 10993-9, ISO 13781 and thefollowing definitions apply.3.1
residual monomerunreacted chemical compound(s) used to build the polymeric chains and still present in the final polymeric material3.2
degradation productchemical compound derived from the breakdown of the polymeric material, including any compound produced byconsecutive chemical reactions3.3
polymeric materialmaterials consisting of long-chain and/or crosslinked molecules composed of units called monomers3.4
hydrolytic degradationscission of chemical bonds in a polymer by the attack of waterNOTE
The water may have a neutral, acidic or alkaline pH value and may contain additional chemical compounds or ions.3.5
oxidative degradationscission of chemical bonds in a polymer by the attack of oxidizing agent(s)3.6
debrisparticulate material produced by the degradation of a polymeric material4 Degradation test methods4.1 General procedures4.1.1 Test designIn accordance with ISO 10993-9, degradation tests shall be used to generate, identify and/or quantify degradationproducts. If degradation is observed in an accelerated test, identification and quantification of the degradationproducts may provide sufficient information for risk analysis. Where this information is insufficient or absent, realtime testing shall be performed. The sequence of steps which shall be followed is described in detail in this part ofISO 10993.NOTE
The accelerated degradation test may be used as a screening test. If no degradation is observed in the acceleratedtest, no real-time degradation test should be necessary.4.1.2 Sample preparationWhen not specifically addressed by the selected method(s), the general aspects of sample prep
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