SIST EN ISO 10993-9:2010

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This part of ISO 10993 considers both non-resorbable and resorbable materials. This part of ISO 10993 is not applicable to: a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available.

Biologische Beurteilung von Medizinprodukten - Teil 9: Rahmen zur Identifizierung und Quantifizierung von möglichen Abbauprodukten (ISO 10993-9:2009)

Dieser Teil von ISO 10993 beschreibt allgemeine Prinzipien zur systematischen Beurteilung von möglichen und beobachteten biologischen Abbauvorgängen bei Medizinprodukten sowie zur Auslegung und Durchführung von biologischen Abbaustudien.
Wenn Produktnormen anwendbare, produktspezifische Methoden zur Identifizierung und Quantifizierung von Abbauprodukten beschreiben, müssen diese Normen als Alternativen berücksichtigt werden. Die Information, die aus diesen Studien erhalten wird, wird in den anderen Teilen der ISO 10993 beschriebenen biologischen Beurteilungen  verwendet.
Dieser Teil von ISO 10993 ist nicht anwendbar für:
a)   Methoden zur Erzeugung von Abbauprodukten durch rein mechanische Prozesse. Methoden zur Erzeugung dieser Art von Abbauprodukten sind, falls vorhanden, in den spezifischen Produktnormen beschrieben;
b)   herauslösbare Komponenten, die keine Abbauprodukte sind.
ANMERKUNG   Diese Norm kann für den Abbau von Materialien in anderen therapeutischen Produkten, z. B. in dem Gerüst von Produkten, die aus Gewebe hergestellt wurden oder in einer Trägermatrix mit der Arzneimittel oder biologische Präparate zugefügt werden. Andere Normen und Leitfäden können auf diese fertigen Produkte angewendet werden.

Évaluation biologique des dispositifs médicaux - Partie 9: Cadre pour l'identification et la quantification des produits potentiels de dégradation (ISO 10993-9:2009)

L'ISO 10993-9:2009 donne les principes généraux pour l'évaluation systématique de la dégradation potentielle et observée des dispositifs médicaux et pour la conception et l'exécution des études de biodégradation. Les informations obtenues de ces études peuvent servir aux évaluations biologiques décrites dans la série de l'ISO 10993. L'ISO 10993-9:2009 aborde à la fois les matériaux résorbables et non résorbables.

Biološko ovrednotenje medicinskih pripomočkov - 9. del: Okvirni sistem za prepoznavanje in ugotavljanje količine morebitnih razgradnih produktov (ISO 10993-9:2009)

Ta del ISO 10993 zagotavlja splošna načela za sistematično ovrednotenje morebitne in opažene biorazgradnje medicinskih pripomočkov ter za zasnovo in izvajanje študij biorazgradnje. Informacije, pridobljene na podlagi teh študij, se lahko uporabljajo pri biološkem vrednotenju, opisanem v seriji ISO 10993. Ta del ISO 10993 obravnava neabsorptivne in absorptivne materiale. Ta del ISO 10993 ne velja za: a) vrednotenje razgradnje, do katere pride zaradi popolnoma mehanskih procesov; če so na voljo, so metodologije za nastanek tovrstnih razgradnih proizvodov opisane v specifičnih standardih za proizvode.

General Information

• Status: Withdrawn
• Publication Date: 10-Feb-2010
• Withdrawal Date: 07-Nov-2021
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 13-Oct-2021
• Due Date: 05-Nov-2021
• Completion Date: 08-Nov-2021
• 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: EN ISO 10993-9:2009 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

Relations

• Replaced By: SIST EN ISO 10993-9:2022 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
• Effective Date: 01-Dec-2021
• Replaces: SIST EN ISO 10993-9:2009 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)
• Effective Date: 01-Mar-2010
• Replaces: SIST EN ISO 10993-9:2009 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-9:2010
01-marec-2010
1DGRPHãþD
SIST EN ISO 10993-9:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO2NYLUQLVLVWHP]D
SUHSR]QDYDQMHLQXJRWDYOMDQMHNROLþLQHPRUHELWQLKUD]JUDGQLKSURGXNWRY,62

Biological evaluation of medical devices - Part 9: Framework for identification and
quantification of potential degradation products (ISO 10993-9:2009)
Biologische Beurteilung von Medizinprodukten - Teil 9: Rahmen zur Identifizierung und
Quantifizierung von möglichen Abbauprodukten (ISO 10993-9:2009)
Évaluation biologique des dispositifs médicaux - Partie 9: Cadre pour l'identification et la
quantification des produits potentiels de dégradation (ISO 10993-9:2009)
Ta slovenski standard je istoveten z: EN ISO 10993-9:2009
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-9:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-9:2010

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SIST EN ISO 10993-9:2010


EUROPEAN STANDARD
EN ISO 10993-9

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2009
ICS 11.100.20 Supersedes EN ISO 10993-9:2009
English Version
Biological evaluation of medical devices - Part 9: Framework for
identification and quantification of potential degradation products
(ISO 10993-9:2009)
Évaluation biologique des dispositifs médicaux - Partie 9: Biologische Beurteilung von Medizinprodukten - Teil 9:
Cadre pour l'identification et la quantification des produits Rahmen zur Identifizierung und Quantifizierung von
potentiels de dégradation (ISO 10993-9:2009) möglichen Abbauprodukten (ISO 10993-9:2009)
This European Standard was approved by CEN on 18 November 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 10993-9:2009: E
worldwide for CEN national Members.

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SIST EN ISO 10993-9:2010
EN ISO 10993-9:2009 (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 10993-9:2010
EN ISO 10993-9:2009 (E)
Foreword
This document (EN ISO 10993-9:2009) 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 June 2010, and conflicting national standards shall be withdrawn at
the latest by June 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 10993-9:2009.
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, 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 10993-9:2009 has been approved by CEN as a EN ISO 10993-9:2009 without any
modification.
3

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SIST EN ISO 10993-9:2010
EN ISO 10993-9:2009 (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 International 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 International Standard given in Table ZA.1 confers, within the limits of the scope of this International
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 this Essential Requirements (ERs) of Qualifying remarks/Notes
International Standard Directive 93/42/EEC on Medical
devices
4, 5, Annex A 7.1, 7.2, 7.5 These relevant Essential
Requirements are only partly
addressed in this International
Standard
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 standard.

4

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SIST EN ISO 10993-9:2010
EN ISO 10993-9:2009 (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 International 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 International Standard given in Table ZB.1 confers, within the limits of the scope of this International
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
The first and second indents of this
4, 5, Annex A 9 (First and second indents only)
relevant Essential Requirement
are only partly addressed in this
International Standard
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 standard.

5

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SIST EN ISO 10993-9:2010

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SIST EN ISO 10993-9:2010

INTERNATIONAL ISO
STANDARD 10993-9
Second edition
2009-12-15

Biological evaluation of medical
devices —
Part 9:
Framework for identification and
quantification of potential degradation
products
Évaluation biologique des dispositifs médicaux —
Partie 9: Cadre pour l'identification et la quantification des produits
potentiels de dégradation




Reference number
ISO 10993-9:2009(E)
©
ISO 2009

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SIST EN ISO 10993-9:2010
ISO 10993-9:2009(E)
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ii © ISO 2009 – All rights reserved

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SIST EN ISO 10993-9:2010
ISO 10993-9:2009(E)
Contents Page
Foreword .iv
Introduction.vi
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Principles for design of degradation studies .2
4.1 General .2
4.2 Preliminary considerations .3
4.3 Study design .3
4.4 Characterization of degradation products from medical devices.4
5 Study report .4
Annex A (normative) Consideration of the need for degradation studies.5
Annex B (informative) Biodegradation study considerations .7
Bibliography.9

© ISO 2009 – All rights reserved iii

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SIST EN ISO 10993-9:2010
ISO 10993-9:2009(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 10993-9 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.
This second edition cancels and replaces the first edition (ISO 10993-9:1999), which has been technically
revised.
ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices:
⎯ Part 1: Evaluation and testing within a risk management process
⎯ 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 skin 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
⎯ Part 14: Identification and quantification of degradation products from ceramics
⎯ Part 15: Identification and quantification of degradation products from metals and alloys
iv © ISO 2009 – All rights reserved

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SIST EN ISO 10993-9:2010
ISO 10993-9:2009(E)
⎯ Part 16: Toxicokinetic study design for degradation products and leachables
⎯ Part 17: Establishment of allowable limits for leachable substances
⎯ Part 18: Chemical characterization of materials
⎯ Part 19: Physico-chemical, morphological and topographical characterization of materials [Technical
Specification]
⎯ Part 20: Principles and methods for immunotoxicology testing of medical devices [Technical Specification]
Future parts will deal with other relevant aspects of biological evaluation.
© ISO 2009 – All rights reserved v

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SIST EN ISO 10993-9:2010
ISO 10993-9:2009(E)
Introduction
This part of ISO 10993 is intended to present the general principles on which the specific material
investigations to identify and quantify degradation products described in ISO 10993-13 (polymers),
ISO 10993-14 (ceramics) and ISO 10993-15 (metals and alloys) are based.
Information obtained from these studies is intended to be used in the biological evaluations described in the
remaining parts of ISO 10993.
The materials used to construct medical devices can form degradation products when exposed to the
biological environment, and in the body these products
...