EN ISO 10993-9:2021
(Main)Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.
This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.
This document is not applicable to:
a) the 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;
NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993.
b) leachable components which are not degradation products;
c) medical devices or components that do not contact the patient's body directly or indirectly.
Biologische Beurteilung von Medizinprodukten - Teil 9: Rahmen zur Identifizierung und Quantifizierung von möglichen Abbauprodukten (ISO 10993-9:2019)
Dieses Dokument beschreibt allgemeine Prinzipien zur systematischen Beurteilung von möglichem und beobachtetem Abbau bei Medizinprodukten durch Planung und Durchführung von In vitro Abbaustudien. Informationen, die aus diesen Studien resultieren, können für die in der Normenreihe ISO 10993 beschriebene biologische Beurteilung verwendet werden.
Dieses Dokument gilt sowohl für Materialien, die dafür vorgesehen sind, vom Körper abgebaut zu werden, als auch für solche, bei denen das nicht vorgesehen ist.
Dieses Dokument gilt nicht für:
a) die Beurteilung des Abbaus durch rein mechanische Prozesse. Methoden zur Generierung dieser Art von Abbauprodukten sind, falls vorhanden, in den spezifischen Produktnormen beschrieben;
ANMERKUNG Rein mechanischer Abbau verursacht meist Partikel. Obwohl diese aus dem Anwendungsbereich dieses Dokuments ausgeschlossen sind, können solche Abbauprodukte eine biologische Reaktion hervorrufen und können daher einer biologischen Beurteilung, wie in anderen Teilen der ISO 10993 beschrieben, unterzogen werden.
b) herauslösbare Komponenten, die keine Abbauprodukte sind;
c) Medizinprodukte oder deren Komponenten, die weder direkt noch indirekt mit dem Körper des Patienten in Berührung kommen.
Évaluation biologique des dispositifs médicaux - Partie 9: Cadre pour l'identification et la quantification des produits potentiels de dégradation (ISO 10993-9:2019)
Le présent document donne les principes généraux pour l'évaluation systématique de la dégradation potentielle et observée des dispositifs médicaux, à travers la conception et l'exécution des études de dégradation in vitro. Les informations obtenues dans le cadre de ces études peuvent servir aux évaluations biologiques décrites dans la série de normes ISO 10993.
Le présent document s'applique aux matériaux conçus pour se dégrader dans le corps, ainsi qu'aux matériaux qui ne sont pas conçus pour se dégrader.
Le présent document ne s'applique pas:
a) à l'évaluation de la dégradation qui se produit uniquement suite à des processus mécaniques; les méthodologies de génération de ce type de produit de dégradation sont décrites, le cas échéant, dans les normes des produits considérés;
NOTE La dégradation purement mécanique donne principalement de la matière sous forme de particules. Bien qu'ils n'entrent pas dans le domaine d'application du présent document, de tels produits de dégradation peuvent entraîner une réponse biologique et peuvent être soumis à une évaluation biologique telle que celle décrite dans les autres parties de l' ISO 10993.
b) aux composants relargables qui ne sont pas des produits de dégradation;
c) aux dispositifs médicaux ou composants qui ne sont pas directement ou indirectement en contact avec le corps du patient.
Biološko ovrednotenje medicinskih pripomočkov - 9. del: Okvirni sistem za prepoznavanje in ugotavljanje količine morebitnih razgradnih produktov (ISO 10993-9:2019)
Ta dokument podaja splošna načela za sistematično ovrednotenje morebitne in opažene razgradnje medicinskih pripomočkov z načrtovanjem in izvedbo študij razgradnje in vitro. Informacije, pridobljene s temi študijami, je mogoče uporabiti pri biološkem ovrednotenju, ki je opisano v skupini standardov ISO 10993. Ta dokument se uporablja za materiale, namenjene razgradnji v telesu, in materiale, ki niso namenjeni razgradnji. Ta dokument se ne uporablja za: a) ovrednotenje razgradnje, ki jo povzročajo izključno mehanski procesi; metodologije za proizvodnjo takšnega razgradnega produkta so opisane v standardih za posamezni izdelek, če so na voljo. OPOMBA: Pri izključno mehanski razgradnji nastanejo večinoma trdni delci. Čeprav to ne spada na področje uporabe tega dokumenta, lahko takšni razgradni produkti izzovejo biološki odziv in so lahko predmet biološkega ovrednotenja, kot je opisano v drugih delih standarda ISO 10993; b) izlužene komponente, ki niso produkti razgradnje; c) medicinske pripomočke ali komponente, ki so v neposrednem ali posrednem stiku z bolnikovim telesom.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2022
Nadomešča:
SIST EN ISO 10993-9:2010
Biološko ovrednotenje medicinskih pripomočkov - 9. del: Okvirni sistem za
prepoznavanje in ugotavljanje količine morebitnih razgradnih produktov (ISO
10993-9:2019)
Biological evaluation of medical devices - Part 9: Framework for identification and
quantification of potential degradation products (ISO 10993-9:2019)
Biologische Beurteilung von Medizinprodukten - Teil 9: Rahmen zur Identifizierung und
Quantifizierung von möglichen Abbauprodukten (ISO 10993-9:2019)
Évaluation biologique des dispositifs médicaux - Partie 9: Cadre pour l'identification et la
quantification des produits potentiels de dégradation (ISO 10993-9:2019)
Ta slovenski standard je istoveten z: EN ISO 10993-9:2021
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 10993-9
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2021
EUROPÄISCHE NORM
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 10993-9:2019)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil 9:
9: Cadre pour l'identification et la quantification des Rahmen zur Identifizierung und Quantifizierung von
produits potentiels de dégradation (ISO 10993- möglichen Abbauprodukten (ISO 10993-9:2019)
9:2019)
This European Standard was approved by CEN on 26 May 2021.
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-CENELEC 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-CENELEC 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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-9:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the general
health and safety requirements of Regulation (EU) 2017/745 on medical devices
aimed to be covered . 5
European foreword
This document (EN ISO 10993-9:2021) has been prepared by Technical Committee ISO/TC 194
"Biological and clinical evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 “Biological and clinical evaluation of medical devices” the secretariat of which is held by
DIN.
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 March 2022, and conflicting national standards shall
be withdrawn at the latest by March 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN 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 Standardization Request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s) / Regulation(s).
For the relationship with EU Directive(s) / Regulation(s), see informative Annex ZA, which is an integral
part of this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this document ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between undated normative references and dated EN and ISO standards
Normative references as Equivalent dated standard
listed in Clause 2 of the ISO
EN ISO or IEC
standard
b
ISO 10993-1 EN ISO 10993-1:2020 ISO 10993-1:2018
a
ISO 10993-2 EN ISO 10993-2:2020 ISO 10993-2: 2020
ISO 10993-13 EN ISO 10993-13:2010 ISO 10993-13:2010
ISO 10993-14 EN ISO 10993-14:2009 ISO 10993-14:2001
b
ISO 10993-15 EN ISO 10993-15:2020 ISO 10993-15:2019
a
Under preparation. Documents are at final stage and have to be submitted to ISO/CS for FDIS vote.
a
Under preparation at European level.
NOTE This part of EN ISO 10993 refers to ISO 10993-1 which itself refers to ISO 14971. In Europe, it should
be assumed that the reference to ISO 14971 is to EN ISO 14971:2020.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 10993-9:2019 has been approved by CEN as EN ISO 10993-9:2021 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the general health and
safety requirements of Regulation (EU) 2017/745 on medical devices aimed
to be covered
This European standard has been prepared under a Commission’s standardisation request to provide
one voluntary means of conforming to the General Safety and Performance Requirements of Regulation
(EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
Foreword, replacing the references in the core text.
NOTE 4 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of Regulation (EU)
2017/745
General health and safety Clause(s)/sub-clause(s) of Remarks/Notes
Requirements of Regulation this EN
(EU) 2017/745
10.1 a), b), c) and h) 4 and Annex A 10.1 a), b), c) and h) only partly
covered by ISO 10993-9, since
the standard does not provide
requirements on design and
manufacture.
However, this part of ISO 10993
provides considerations on how
to plan a degradation study in
order to obtain quantitative
degradation data as a basis for
the safety evaluation of a
medical device.
Therefore, this standard
provides a means to evaluate
degradation risks associated
with the materials which are
used.
More product group specific
information can be found in
ISO 10993-13 (polymers),
ISO 10993-14 (ceramics) and
ISO 10993-15 (metals and
alloys)
These tests are not intended to
evaluate or determine the
performance of the test sample
in terms of mechanical or
functional loading.
For 10.1 a), flammability is not
covered.
10.4.1 (first paragraph) 4 and Annex A 10.4.1 is only partly covered by
this document. However, this
part of ISO 10993 specifies the
general principles that govern
the design, conduct and
interpretation of studies to
identify and quantify
degradation products arising
from materials intended for use
in medical devices in order to
obtain quantitative degradation
data as a basis for the safety
evaluation of a medical device.
Therefore, this standard
provides a means to investigate
the risks posed by degradation
products that may be released
from the medical device.
This document does not apply
to particles, wear debris or
processing residues
General Note: Presumption of conformity depends on also complying with the relevant parts of the ISO 10993-
series.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 10993-9
Third edition
2019-11
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 10993-9:2019(E)
©
ISO 2019
ISO 10993-9:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2019 – All rights reserved
ISO 10993-9:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles for design of degradation studies .
...
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