EN ISO 10993-15:2023
(Main)Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
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Biologische Beurteilung von Medizinprodukten - Teil 15: Qualitativer und quantitativer Nachweis von Abbauprodukten aus Metallen und Legierungen (ISO 10993-15:2019)
Dieses Dokument legt allgemeine Anforderungen zur Konzeption von Prüfungen für den qualitativen und quantitativen Nachweis von Abbauprodukten von fertigen Medizinprodukten aus Metall oder entsprechenden Werkstoffproben im Endzustand fest, die zur klinischen Anwendung bereit sind.
Dieses Dokument ist nur auf solche Abbauprodukte anwendbar, die durch eine chemische Veränderung des fertigen Metallproduktes in einer In vitro Prüfung erzeugt werden. Aufgrund der Natur dieser In vitro Prüfungen entsprechen die Prüfergebnisse in etwa dem In vivo Verhalten des Implantats oder des Werkstoffs. Die beschriebenen chemischen Verfahren sind ein Mittel, um Abbauprodukte für weitere Bewertungen zu erzeugen.
Dieses Dokument ist anwendbar sowohl auf Materialien, die dafür vorgesehen sind, vom Körper abgebaut zu werden, als auch auf solche, bei denen das nicht vorgesehen ist.
Dieses Dokument gilt nicht für eine 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 partikelförmiges Material. Obwohl dieses aus dem Anwendungsbereich dieses Dokuments ausgeschlossen ist, können solche Abbauprodukte eine biologische Reaktion hervorrufen und einer biologischen Beurteilung, wie in anderen Teilen der ISO 10993 beschrieben, unterzogen werden.
In Anbetracht des breiten Spektrums an metallischen Werkstoffen, die für Medizinprodukte verwendet werden, werden keine spezifischen analytischen Verfahren zum quantitativen Nachweis der Abbauprodukte festgelegt. Der Nachweis von Spurenelementen (< 10−6 w/w), die in bestimmten Metallen oder Legierungen vorhanden sind, wird in diesem Dokument nicht beschrieben. Ebenso legt dieses Dokument keine spezifischen Anforderungen für akzeptierbare Toleranzwerte von Abbauprodukten fest.
Dieses Dokument beschreibt nicht die biologische Aktivität der Abbauprodukte. (Hierzu wird auf die anwendbaren Abschnitte von ISO 10993 1 und ISO 10993 17 verwiesen.)
Évaluation biologique des dispositifs médicaux - Partie 15: Identification et quantification des produits de dégradation issus des métaux et alliages (ISO 10993-15:2019)
Le présent document spécifie les exigences générales pour la conception des essais d'identification et de quantification des produits de dégradation issus de dispositifs médicaux métalliques finaux ou d'échantillons des matériaux correspondants prêts pour une utilisation clinique.
Le présent document ne s'applique qu'aux produits de dégradation créés par une modification chimique du dispositif métallique final et au moyen d'un essai de dégradation in vitro. En raison de la nature des essais in vitro, les résultats d'essai donnent une approximation du comportement in vivo de l'implant ou du matériau. En raison du caractère accéléré de ces essais, la méthodologie chimique décrite est un moyen de générer des produits de dégradation en vue d'analyses ultérieures.
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 n'est pas applicable 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 subir une évaluation biologique telle que celle décrite dans les autres parties de l'ISO 10993.
En raison de la grande variété des matériaux métalliques utilisés dans la fabrication des dispositifs médicaux, la présente partie de l'ISO 10993 n'indique aucune technique d'analyse spécifique pour la quantification des produits de dégradation. Le présent document ne traite pas de l'identification d'éléments à l'état de trace (< 10−6 w/w) contenus dans le métal ou l'alliage analysé. Il ne fournit aucune exigence spécifique relative aux niveaux admissibles de produits de dégradation.
Le présent document ne couvre pas l'activité biologique des produits de dégradation (pour cela, voir les articles correspondants de l'ISO 10993-1 et de l'ISO 10993-17).
Biološko ovrednotenje medicinskih pripomočkov - 15. del: Identifikacija in ugotavljanje količine razgradnih produktov iz kovin in zlitin (ISO 10993-15:2019)
Ta dokument določa splošne zahteve za oblikovanje preskusov za identifikacijo in ugotavljanje količine razgradnih produktov iz končnih kovinskih medicinskih pripomočkov ali vzorcev ustreznih materialov, ki so pripravljeni za klinično uporabo.
Ta dokument se uporablja samo za razgradne produkte, ki nastanejo s kemičnim spreminjanjem končnega kovinskega pripomočka pri preskusu razgradnje in vitro. Zaradi narave preskusov in vitro pomenijo rezultati preskusov približek obnašanja vsadka ali materiala in vivo. Opisane kemijske metodologije so načini ustvarjanja razgradnih produktov za nadaljnje ocenjevanje.
Ta dokument se uporablja za materiale, namenjene razgradnji v telesu, in materiale, ki niso namenjeni razgradnji.
Ta dokument se ne uporablja za: 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: Povsem mehanska razgradnja povzroča predvsem trdne delce. 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.
Zaradi širokega izbora kovinskih materialov, ki se uporabljajo v medicinskih pripomočkih, niso opredeljene posebne analitične tehnike za ugotavljanje količine razgradnih produktov. Identifikacija elementov v sledovih
(<10–6 m/m), ki so v določeni kovini ali zlitini, ni obravnavana v tem dokumentu kot tudi niso podane posebne
zahteve za sprejemljive ravni razgradnih produktov v tem dokumentu.
Ta dokument ne vključuje biološke aktivnosti razgradnih produktov. (namesto tega glej ustrezne
točke standardov ISO 10993-1 in ISO 10993-17).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2023
Nadomešča:
SIST EN ISO 10993-15:2009
Biološko ovrednotenje medicinskih pripomočkov - 15. del: Identifikacija in
ugotavljanje količine razgradnih produktov iz kovin in zlitin (ISO 10993-15:2019)
Biological evaluation of medical devices - Part 15: Identification and quantification of
degradation products from metals and alloys (ISO 10993-15:2019)
Biologische Beurteilung von Medizinprodukten - Teil 15: Qualitativer und quantitativer
Nachweis von Abbauprodukten aus Metallen und Legierungen (ISO 10993-15:2019)
Évaluation biologique des dispositifs médicaux - Partie 15: Identification et quantification
des produits de dégradation issus des métaux et alliages (ISO 10993-15:2019)
Ta slovenski standard je istoveten z: EN ISO 10993-15:2023
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 10993-15
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2023
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-15:2009
English Version
Biological evaluation of medical devices - Part 15:
Identification and quantification of degradation products
from metals and alloys (ISO 10993-15:2019)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil
15: Identification et quantification des produits de 15: Qualitativer und quantitativer Nachweis von
dégradation issus des métaux et alliages (ISO 10993- Abbauprodukten aus Metallen und Legierungen (ISO
15:2019) 10993-15:2019)
This European Standard was approved by CEN on 19 April 2023.
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, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-15:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 4
European foreword
This document (EN ISO 10993-15:2023) 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 November 2023, and conflicting national standards
shall be withdrawn at the latest by November 2023.
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 10993-15:2009.
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 website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10993-15:2019 has been approved by CEN as EN ISO 10993-15:2023 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 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] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
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 and application of the
edition of the normatively referenced standards as given in Table ZA.2 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.
Where a definition in this harmonised standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the differences shall be indicated in the Annex Z. For the purpose of using
this standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set
out in this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this document
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region the standard can only
support European regulatory requirements to the extent of the scope of the European Regulation for
medical devices ((EU) 2017/745).
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 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 [OJ L 117] and to system or process requirements including those relating
to quality management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-
Performance
clause(s)
Requirements of Remarks / Notes
Regulation (EU)
of this EN
2017/745
10.1 a), b), c) and h) 10.1 a), b), c) and h) are only partly covered by ISO
10993-15, 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
of metallic materials intended for use in medical
devices in order to obtain quantitative degradation
data as a basis for the safety evaluation of a medical
4, 6 and 7
device.
Therefore, this standard provides a means to
evaluate degradation risks associated with the
metallic materials which are used.
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.
NOTE 4 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 14971:2019/A11:2021.
General Note: Presumption of conformity depends on also complying with the relevant parts of the ISO 10993
series.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 International Column 3 Column 4
Reference in Standard Edition
Title Corresponding European
Clause 2
Standard Edition
ISO 3585 ISO 3585:1998 Borosilicate glass 3.3 - None
Properties
For applicable standard
edition see Column 2
ISO 3696 ISO 3696:1987 Water for analytical EN ISO 3696:1995
laboratory use - Specification
and test methods
ISO 8044 ISO 8044:2020 Corrosion of metals and alloys EN ISO 8044:2020
- Vocabulary
ISO 10993-1 ISO 10993-1:2018 Biological evaluation of EN ISO 10993-1:2020
medical devices - Part 1:
Column 1 Column 2 International Column 3 Column 4
Reference in Standard Edition
Title Corresponding European
Clause 2
Standard Edition
Evaluation and testing within
a risk management process
ISO 10993-9 ISO 10993-9:2019 Biological evaluation of EN ISO 10993-9:2021
medical devices - Part 9:
Framework for identification
and quantification of potential
degradation products
ISO 10993-12 ISO 10993-12:2021 Biological evaluation of EN ISO 10993-12:2021
medical devices - Part 12:
Sample preparation and
reference materials
ISO 10993-13 ISO 10993-13:2010 Biological evaluation of EN ISO 10993-13:2010
medical devices - Part 13:
Identification and
quantification of degradation
products from polymeric
medical devices
ISO 10993-14 ISO 10993-14:2001 Biological evaluation of EN ISO 10993-14:2009
medical devices - Part 14:
Identification and
quantification of degradation
products from ceramics
ISO 10993-16 ISO 10993-16:2017 Biological evaluation of EN ISO 10993-16:2017
medical devices - Part 16:
Toxicokinetic study design for
degradation products and
leachables
The documents listed in the Column 1 of table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of table ZA.2.
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 10993-15
Second edition
2019-11
Biological evaluation of medical
devices —
Part 15:
Identification and quantification of
degradation products from metals
and alloys
Évaluation biologique des dispositifs médicaux —
Partie 15: Identification et quantification des produits de dégradation
issus des métaux et alliages
Reference number
ISO 10993-15:2019(E)
©
ISO 2019
ISO 10993-15:2019(E)
© ISO 2019
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ISO 10993-15:2019(E)
Contents Page
Foreword .iv
Introduction .
...
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