EN ISO 10993-1:2020
(Main)Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
This document specifies:
— the general principles governing the biological evaluation of medical devices within a risk management process;
— the general categorization of medical devices based on the nature and duration of their contact with the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the medical device;
— the assessment of the biological safety of the medical device.
This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with:
— the patient's body during intended use;
— the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).
This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.
This document also gives guidelines for the assessment of biological hazards arising from:
— risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;
— breakage of a medical device or medical device component which exposes body tissue to new or novel materials.
Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im Rahmen eines Risikomanagementsystems (ISO 10993-1:2018, einschließlich korrigierte Fassung 2018-10)
Dieses Dokument legt das Folgende fest:
- die allgemeinen Grundsätze, die für die biologische Beurteilung von Medizinprodukten innerhalb eines Risikomanagementverfahrens gelten;
- die allgemeine Einteilung von Medizinprodukten, basierend auf der Art und Dauer von deren Kontakt mit dem Körper;
- die Auswertung vorhandener relevanter Daten aus allen Quellen;
- die Ermittlung von Lücken in den verfügbaren Datensätzen auf der Grundlage einer Risikoanalyse;
- die Ermittlung zusätzlicher Datensätze, die für die Analyse der biologischen Sicherheit des Medizin¬produkts notwendig sind;
- die Beurteilung der biologischen Sicherheit des Medizinprodukts.
Dieses Dokument gilt für die Beurteilung von Materialien und Medizinprodukten, von denen erwartet wird, dass sie direkt oder indirekt in Kontakt kommen mit
- dem Körper des Patienten im Rahmen der bestimmungsgemäßen Verwendung, und/oder
- dem Körper des Anwenders, wenn das Medizinprodukt zum Schutz vorgesehen ist (z. B. OP-Hand-schuhe, Masken und andere Produkte).
Dieses Dokument ist anwendbar auf die biologische Beurteilung aller Arten an Medizinprodukten, einschließlich aktiver, nicht aktiver, implantierbarer und nicht implantierbarer Medizinprodukte.
Dieses Dokument bietet außerdem einen Leitfaden zur Beurteilung von biologischen Gefährdungen aufgrund von
- Risiken, wie etwa Veränderungen des Medizinprodukts im Laufe der Zeit, als Teil der biologischen Sicherheitsbewertung, und/oder
- Beschädigung eines Medizinprodukts oder eines Bestandteils des Medizinprodukts, was zur Folge hat, dass Körpergewebe neuen oder neu entstandenen Materialien ausgesetzt wird.
Andere Teile der ISO 10993 decken spezifische Aspekte der biologischen Beurteilungen und zugehörigen Prüfungen ab. Spezifische Normen für das Medizinprodukt oder Produktnormen behandeln die mechanische Prüfung.
Gefährdungen im Zusammenhang mit Bakterien, Schimmelpilzen, Hefen, Viren, den Erregern der Trans¬missiblen Spongiformen Enzephalopathie (TSE) und weiteren pathogenen Organismen werden in diesem Dokument nicht behandelt.
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque (ISO 10993-1:2018, y compris version corrigée 2018-10)
Le présent document spécifie:
— les principes généraux sur lesquels repose l'évaluation biologique des dispositifs médicaux dans un processus de gestion du risque;
— la classification générale des dispositifs médicaux, fondée sur la nature et la durée de leur contact avec le corps humain;
— l'évaluation de toutes les données pertinentes existantes;
— l'identification de lacunes dans les ensembles de données disponibles sur la base d'une analyse de risque;
— l'identification d'ensembles de données supplémentaires nécessaires à l'analyse de la sécurité biologique du dispositif médical;
— l'évaluation de la sécurité biologique du dispositif médical.
Le présent document s'applique à l'évaluation de matériaux et dispositifs médicaux qui sont destinés à entrer en contact direct ou indirect avec:
— le corps du patient pendant leur utilisation prévue;
— le corps de l'utilisateur si le dispositif médical est destiné à la protection (par exemple gants chirurgicaux, masques et autres).
Le présent document est applicable à l'évaluation biologique de tous types de dispositifs médicaux, y compris les dispositifs médicaux actifs, non actifs, implantables et non implantables.
Le présent document donne également des lignes directrices pour l'évaluation des dangers biologiques provenant de:
— risques tels que des modifications du dispositif médical au fil du temps, dans le cadre de l'évaluation de sécurité biologique générale;
— rupture d'un dispositif médical ou d'un composant de dispositif médical qui expose des tissus de l'organisme à des matériaux nouveaux.
Les autres parties de l'ISO 10993 couvrent des aspects spécifiques des évaluations biologiques et des essais associés. Des normes de produits ou spécifiques aux dispositifs traitent des essais mécaniques.
Le présent document exclut les dangers relatifs aux bactéries, moisissures, levures, virus, agents de l'encéphalopathie spongiforme transmissible (EST) et autres agents pathogènes.
Biološko ovrednotenje medicinskih pripomočkov - 1. del: Ocena in preskušanje znotraj procesa obvladovanja tveganja (ISO 10993-1:2018, vključno s popravkom verzije 2018-11)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2021
Nadomešča:
SIST EN ISO 10993-1:2010
SIST EN ISO 10993-1:2010/AC:2010
Biološko ovrednotenje medicinskih pripomočkov - 1. del: Ocena in preskušanje
znotraj procesa obvladovanja tveganja (ISO 10993-1:2018, vključno s popravkom
verzije 2018-11)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process (ISO 10993-1:2018, including corrected version 2018-11)
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im
Rahmen eines Risikomanagementsystems (ISO 10993-1:2018, einschließlich korrigierte
Fassung 2018-11)
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein
d'un processus de gestion du risque (ISO 10993-1:2018, y compris version corrigée
2018-11)
Ta slovenski standard je istoveten z: EN ISO 10993-1:2020
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 10993-1
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2020
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-1:2009
English Version
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
(ISO 10993-1:2018, including corrected version 2018-11)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil 1:
1: Évaluation et essais au sein d'un processus de Beurteilung und Prüfungen im Rahmen eines
gestion du risque (ISO 10993-1:2018, y compris Risikomanagementsystems (ISO 10993-1:2018,
version corrigée 2018-11) einschließlich korrigierte Fassung 2018-11)
This European Standard was approved by CEN on 10 December 2020.
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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-1:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 10993-1:2020) 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 June 2021, and conflicting national standards shall be
withdrawn at the latest by June 2021.
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 10993-1:2009.
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 10993-1:2018, including corrected version 2018-11 has been approved by CEN as
INTERNATIONAL ISO
STANDARD 10993-1
Fifth edition
2018-08
Corrected version
2018-10
Biological evaluation of medical
devices —
Part 1:
Evaluation and testing within a risk
management process
Évaluation biologique des dispositifs médicaux —
Partie 1: Évaluation et essais au sein d'un processus de gestion du
risque
Reference number
ISO 10993-1:2018(E)
©
ISO 2018
ISO 10993-1:2018(E)
© ISO 2018
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 2018 – All rights reserved
ISO 10993-1:2018(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General principles applying to biological evaluation of medical devices .5
5 Categorization of medical devices . 9
5.1 General . 9
5.2 Categorization by nature of body contact . 9
5.2.1 Non-contacting medical devices. 9
5.2.2 Surface-contacting medical devices .10
5.2.3 Externally communicating medical devices .10
5.2.4 Implant medical devices .11
5.3 Categorization by duration of contact .11
5.3.1 Contact duration categories .11
5.3.2 Transitory-contacting medical devices .11
5.3.3 Medical devices with multiple contact duration categories .11
6 Biological evaluation process .12
6.1 Physical and chemical information for biological risk analysis .12
6.2 Gap analysis and selection of biological endpoints for assessment .12
6.3 Biological testing .13
6.3.1 General.13
6.3.2 Testing for evaluation .14
7 Interpretation of biological evaluation data and overall biological risk assessment .18
Annex A (informative) Endpoints to be addressed in a biological risk assessment.20
Annex B (informative) Guidance on the conduct of biological evaluation within a risk
management process .25
Annex C (informative) Suggested procedure for literature review .38
Bibliography .40
ISO 10993-1:2018(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of
medical devices.
This fifth edition cancels and replaces the fourth edition (ISO 10993-1:2009), which has been technically
revised. It also incorporates the Technical Corrigendum ISO 10993-1:2009/Cor.1:2010.
The main changes compared to the previous edition are as follows:
a) revised Annex A “Endpoints to be addressed in a biological risk assessment” with new columns for
“physical and/or chemical information” and “material mediated pyrogenicity” as well as columns
for “chronic toxicity,” “carcinogenicity,” “reproductive/developmental toxicity,” and “degradation”
which now indicates “endpoints” to be considered with “E” (instead of “tests” to be conducted with
an “X”);
b) replaced Annex B “Guidance on the risk management process” with “Guidance on the conduct of
biological evaluation within a risk management process” (formerly ISO TR 15499);
c) additional definitions for terms used throughout the ISO 10993 series of standards;
d) additional information on the evaluation of “Non-contacting medical devices”
...
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