EN ISO 10993-13:2010

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

ISO 10993‑13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.
ISO 10993‑13:2010 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that 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. ISO 10993‑13:2010 considers only non-resorbable polymers. Similar, but appropriately modified procedures may be applicable for resorbable polymers.
ISO 10993‑13:2010 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 or biological factors such as enzymes, other proteins and cellular activity.

Biologische Beurteilung von Medizinprodukten - Teil 13: Qualitativer und quantitativer Nachweis von Abbauprodukten in Medizinprodukten aus Polymeren (ISO 10993-13:2010)

Dieser Teil von ISO 10993 legt allgemeine Anforderungen an den Entwurf und an die Auslegung von
Prüfungen in einer simulierten Umgebung, zur Identifizierung und Quantifizierung von Abbauprodukten aus
fertig bearbeiteten Medizinprodukten aus Kunststoff, so wie sie in der Klinik zur Anwendung kommen, fest.
Dieser Teil von ISO 10993 beschreibt zwei Prüfverfahren zur Erzeugung von Abbauprodukten, eine
beschleunigte Abbauprüfung als Screeningverfahren und eine Echtzeitabbauprüfung in einer simulierten
Umgebung. Für Materialien, die dafür gedacht sind, in situ zu polymerisieren, wird für die Prüfung der
abgebundene oder ausgehärtete Kunststoff verwendet. Die erhaltenen Daten dienen zur biologischen
Beurteilung der Kunststoffe. Dieser Teil von ISO 10993 betrachtet lediglich nicht-resorbierbare Polymere.
Ähnliche, jedoch entsprechend modifizierte Verfahren dürfen für resorbierbare Polymere angewendet werden.
Dieser Teil von ISO 10993 beschreibt nur die Abbauprodukte, die durch eine chemische Veränderung des
fertigen Kunststoffproduktes erzeugt werden. Er ist nicht anwendbar auf jenen Abbau von Medizinprodukten,
der während der vorgesehenen Anwendung durch mechanische Belastungen, durch Abrieb, durch elektromagnetische
Strahlung oder durch biologische Mediatoren wie Enzyme, andere Proteine und zelluläre Aktivität
entsteht.
ANMERKUNG Ein informativer Text zur umgebungsbedingten Spannungsrissbildung (ESC) von Polymeren ist als
mögliche Hilfe für die Konzipierung von Degradationsstudien beigefügt (siehe Anhang B).
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, ISO 10993-16 und ISO 10993-17
bewertet werden.
Aufgrund des großen Anwendungsbereiches von Kunststoffen in Medizinprodukten wird keine spezielle
Analysentechnik angegeben oder vorgeschrieben. In diesem Teil von ISO 10993 werden auch keine spezifischen

Évaluation biologique des dispositifs médicaux - Partie 13: Identification et quantification de produits de dégradation de dispositifs médicaux à base de polymères (ISO 10993-13:2010)

L'ISO 10993-13:2010 fournit des exigences générales pour la conception des essais dans un environnement simulé permettant d'identifier et de quantifier les produits de dégradation de dispositifs médicaux à base de polymères destinés à un usage médical.
L'ISO 10993-13:2010 décrit deux méthodes d'essai permettant de générer des produits de dégradation, un essai de dégradation accélérée utilisée comme méthode à effet éliminatoire et un essai de dégradation en temps réel dans un environnement simulé. Pour les matériaux destinés à polymériser in situ, le polymère durci ou cuit doit être utilisé pour les essais. Les données obtenues doivent être utilisées lors de l'évaluation biologique du polymère. L'ISO 10993-13:2010 ne prend en considération que les polymères non résorbables. Des modes opératoires similaires, mais auxquels ont été apportées les modifications appropriées, peuvent s'appliquer aux polymères résorbables.
L'ISO 10993-13:2010 ne traite que des produits de dégradation résultant d'une altération chimique du dispositif médical à base de polymères dans son état final. Elle ne s'applique pas à la dégradation consécutive à une contrainte mécanique, à l'usure, à des rayonnements électromagnétiques ou à des facteurs biologiques tels que les enzymes, d'autres protéines et l'activité cellulaire, au cours de la durée d'utilisation prévue.

Biološko ovrednotenje medicinskih pripomočkov - 13. del: Prepoznavanje in ugotavljanje količine razgradnih produktov polimerov, iz katerih so izdelani medicinski pripomočki (ISO 10993-13:2010)

Ta del ISO 10993 podaja splošne zahteve za načrtovanje preskusov v simuliranem okolju za prepoznavanje in ugotavljanje količine razgradnih produktov iz dokončanih medicinskih naprav iz polimerov, pripravljenih za klinično uporabo. Ta del ISO 10993 opisuje dve preskusni metodi za pridobivanje razgradnih produktov, pospešeni preskus razgradnje kot metodo presajanja ter preskus razgradnje v realnem času v simuliranem okolju. Pri materialih, ki so namenjeni za in situ polimerizacijo, se za preskušanje uporabi ulit ali vulkaniziran polimer. Pridobljeni podatki se uporabijo za biološko vrednotenje polimera. Ta del ISO 10993 obravnava le neabsorbtivne polimere. Podobni, vendar primerno spremenjeni postopki, lahko veljajo za absorptivne polimere. Ta del ISO 10993 obravnava le tiste postopke razgradnje, ki jih generira kemična sprememba dokončanih naprav iz polimerov. Ne velja za razgradnjo naprave, ki je inducirana med njeno predvideno uporabo z mehanskim udarcem, obrabo ali elektromagnetnim sevanjem oziroma z biološkimi dejavniki, kot so encimi,  drugi proteini in celična dejavnost.

General Information

• Status: Published
• Publication Date: 14-Jun-2010
• Withdrawal Date: 30-Dec-2010
• ICS: 11.100.20 - Biological evaluation of medical devices
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Jun-2010
• Completion Date: 15-Jun-2010
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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 10993-13:2010 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

Relations

• Replaces: EN ISO 10993-13:2009 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)
• Effective Date: 04-Jul-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2010
1DGRPHãþD
SIST EN ISO 10993-13:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO3UHSR]QDYDQMHLQ
XJRWDYOMDQMHNROLþLQHUD]JUDGQLKSURGXNWRYSROLPHURYL]NDWHULKVRL]GHODQL
PHGLFLQVNLSULSRPRþNL,62
Biological evaluation of medical devices - Part 13: Identification and quantification of
degradation products from polymeric medical devices (ISO 10993-13:2010)
Biologische Beurteilung von Medizinprodukten - Teil 13: Qualitativer und quantitativer
Nachweis von Abbauprodukten in Medizinprodukten aus Kunststoff (ISO 10993-13:2010)
Évaluation biologique des dispositifs médicaux - Partie 13: Identification et quantification
de produits de dégradation de dispositifs médicaux à base de polymères (ISO 10993-
13:2010)
Ta slovenski standard je istoveten z: EN ISO 10993-13:2010
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 10993-13
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2010
ICS 11.100.20 Supersedes EN ISO 10993-13:2009
English Version
Biological evaluation of medical devices - Part 13: Identification
and quantification of degradation products from polymeric
medical devices (ISO 10993-13:2010)
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
13:2010) 10993-13:2010)
This European Standard was approved by CEN on 5 June 2010.

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, Croatia, 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
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-13:2010: 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
This document (EN ISO 10993-13:2010) has been prepared by Technical Committee ISO/TC 194 "Biological
evaluation of medical devices" in collaboration with 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 December 2010, and conflicting national standards shall be withdrawn
at the latest by December 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 10993-13:2009.
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.
For relationship with EU Directives, see informative Annex ZA and ZB, which are integral parts 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, Croatia, 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 10993-13:2010 has been approved by CEN as a EN ISO 10993-13:2010 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 European Standard is cited in the Official Journal of the European Union under that Directive and
has been implemented as a national standard in at least one Member State, compliance with the clauses of
this European Standard given in Table ZA.1 confers, within the limits of the scope of this Intenational
Standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and
associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on Medical
devices
Clause(s)/subclause(s) of Essential Requirements (ERs) of Directive Qualifying remarks/notes
this European Standard 93/42/EEC on Medical devices
These relevant Essential
4, 5 and 6 7.1 and 7.5
Requirements are only partly
addressed in this standard.
General note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of
ISO 10993-1.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this European 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 European Standard is cited in the Official Journal of the European Union under that Directive and
has been implemented as a national standard in at least one Member State, compliance with the clauses of
this European Standard given in Table ZB.1 confers, within the limits of the scope of this European Standard,
a presumption of conformity with the corresponding Essential Requirements of that Directive and associated
EFTA regulations.
Table ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC on Active
Implantable Medical Devices
Essential Requirements (ERs) of
Clause(s)/subclause(s) of this Qualifying remarks/notes
Directive 90/385/EEC on Active
European Standard
Implantable Medical Devices
4, 5 and 6 9 (first and second indents only) The first and second indents of
this relevant Essential
Requirement are only partly
addressed in this standard.
General note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of
ISO 10993-1.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this European Standard.
INTERNATIONAL ISO
STANDARD 10993-13
Second edition
2010-06-15
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

Reference number
ISO 10993-13:2010(E)
©
ISO 2010
ISO 10993-13:2010(E)
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ISO 10993-13:2010(E)
Contents Page
Foreword .iv
Introduction.vi
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Degradation test methods .2
4.1 General procedures.2
4.2 Accelerated degradation test .5
4.3 Real-time degradation test in a simulated environment .6
5 Test procedures.6
5.1 General .6
5.2 Initial material characterization.6
5.3 Accelerated degradation test .6
5.4 Real-time degradation test in a simulated environment .9
6 Test report.10
Annex A (informative) Analytical methods.11
Annex B (informative) Environmental stress cracking (ESC) of polymers.12
Bibliography.14

ISO 10993-13:2010(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 C
...