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)

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.

Évaluation 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

• Status: Withdrawn
• Publication Date: 28-Apr-2009
• Withdrawal Date: 14-Jun-2010
• ICS: 11.100 - Laboratory medicine
• 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: 9960 - Withdrawal effective - Withdrawal
• 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 10993-13:2009 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

Relations

• Replaces: EN 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)
• Effective Date: 08-Jun-2022
• Replaced By: 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)
• Effective Date: 04-Jul-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-13:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 10993-13:2000
%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 10993-13:1998)
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 d
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