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)

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 evacuation 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 included during its intended use by mechanical stress, wear or electromagnetic radiation.  The biological activity of the debris and soluble degradation products is not adressed 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)

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

• Status: Withdrawn
• Publication Date: 14-Nov-1998
• 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 10993-13:2000 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

Relations

• Replaced By: 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: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-13:2000
01-januar-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 a base de polymeres (ISO 10993-
13:1998)
Ta slovenski standard je istoveten z: EN ISO 10993-13:1998
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-13:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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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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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 [e-mail]
Printed in Switzerland
ii

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©
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
degrada
...