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

Status
Published
Publication Date
27-Jun-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
27-Aug-2018
Completion Date
28-Jun-2018

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SLOVENSKI STANDARD
SIST EN ISO 10993-1:2021
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
SIST EN ISO 10993-1:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-1:2021
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SIST EN ISO 10993-1:2021
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.
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SIST EN ISO 10993-1:2021
EN ISO 10993-1:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 10993-1:2021
EN ISO 10993-1:2020 (E)
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

EN ISO 10993-1:2020 without any modification.
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SIST EN ISO 10993-1:2021
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SIST EN ISO 10993-1:2021
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
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SIST EN ISO 10993-1:2021
ISO 10993-1:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 10993-1:2021
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 2018 – All rights reserved iii
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SIST EN ISO 10993-1:2021
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” and new information

on the evaluation of “Transitory-contacting medical devices”;

e) additional information on the evaluation of nanomaterials, and absorbable materials;

f) additional reference to ISO 18562 (all parts) for “Biocompatibility evaluation of breathing gas

pathways in healthcare applications”;
g) significant editing changes throughout the document;
A list of all parts in the ISO 10993 series can be found on the ISO website.

This corrected version of ISO 10993-1:2018 incorporates the following correction.

iv © ISO 2018 – All rights reserved
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SIST EN ISO 10993-1:2021
ISO 10993-1:2018(E)
—In Table A.1, 6 column, “Sensitization” has been added as a table heading.
© ISO 2018 – All rights reserved v
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SIST EN ISO 10993-1:2021
ISO 10993-1:2018(E)
Introduction

The primary aim of this document is the protection of humans from potential biological risks arising

from the use of medical devices. It is compiled from numerous International and national standards

and guidelines concerning the biological evaluation of medical devices. It is intended to describe the

biological evaluation of medical devices within a risk management process, as part of the overall

evaluation and development of each medical device. This approach combines the review and evaluation

of existing data from all sources with, where necessary, the selection and application of additional tests,

thus enabling a full evaluation to be made of the biological responses to each medical device, relevant

to its safety in use. The term “medical device” is wide-ranging and, at one extreme, consists of a single

material, which can exist in more than one physical form, and at the other extreme, of a medical device

consisting of numerous components made of more than one material.

This document addresses the determination of the biological response to medical devices, mostly in a

general way, rather than in a specific device-type situation. Thus, for a complete biological evaluation, it

classifies medical devices according to the nature and duration of their anticipated contact with human

tissues when in use and indicates, in a matrix, the biological endpoints that are thought to be relevant in

the consideration of each medical device category. See also 3.14, Note 1 to entry.

The range of biological hazards is wide and complex. The biological response to a constituent material

alone cannot be considered in isolation from the overall medical device design. Thus, in designing a

medical device, the choice of the best material with respect to its biocompatibility might result in a

less functional medical device, biocompatibility being only one of a number of characteristics to be

considered in making that choice. Where a material is intended to interact with tissue in order to

perform its function, the biological evaluation needs to address this.

Biological responses that are regarded as adverse, caused by a material in one application, might not be

regarded as such in a different situation. Biological testing is based upon, among other things, in vitro

and ex vivo test methods and upon animal models, so that the anticipated behaviour when a medical

device is used in humans can be judged only with caution, as it cannot be unequivocally concluded

that the same biological response will also occur in this species. In addition, differences in the manner

of response to the same material among individuals indicate that some patients can have adverse

reactions, even to well-established materials.

The primary role of this document is to serve as a framework in which to plan a biological evaluation. A

secondary role is to utilize scientific advances in our understanding of basic mechanisms, to minimize

the number and exposure of test animals by giving preference to in vitro models and to chemical,

physical, morphological, and topographical characterization testing, in situations where these methods

yield equally relevant information to that obtained from in vivo models.

It is not intended that this document provide a rigid set of test methods, including pass/fail criteria,

as this might result in either an unnecessary constraint on the development and use of novel medical

devices, or a false sense of security in the general use of medical devices. Where a particular application

warrants it, experts in the product or in the area of application concerned can choose to establish

specific tests and criteria, described in a product-specific vertical standard.

ISO 10993 series is intended for use by professionals, appropriately qualified by training and experience,

who are able to interpret its requirements and judge the outcome of the evaluation for each medical

device, taking into consideration all the factors relevant to the medical device, its intended use and the

current knowledge of the medical device provided by review of the scientific literature and previous

clinical experience.

Informative Annex A contains a table that is generally helpful in identifying endpoints recommended

in the biocompatibility evaluation of medical devices, according to their category of body contact and

duration of clinical exposure. Informative Annex B contains guidance for the application of the risk

management process to medical devices which encompasses biological evaluation.
vi © ISO 2018 – All rights reserved
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SIST EN ISO 10993-1:2021
INTERNATIONAL STANDARD ISO 10993-1:2018(E)
Biological evaluation of medical devices —
Part 1:
Evaluation and testing within a risk management process
1 Scope
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.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 10993-2:2006, Biological evaluation of medical devices — Part 2: Animal welfare requirements

© ISO 2018 – All rights reserved 1
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SIST EN ISO 10993-1:2021
ISO 10993-1:2018(E)

ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and

reproductive toxicity

ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

ISO 10993-9, Biological evaluation of medical devices — Part 9: Framework for identification and

quantification of potential degradation products

ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

ISO 10993-12, Biological evaluation of medical devices — Part 12: Sample preparation and reference

materials

ISO 10993-13, Biological evaluation of medical devices — Part 13: Identification and quantification of

degradation products from polymeric medical devices

ISO 10993-14, Biological evaluation of medical devices — Part 14: Identification and quantification of

degradation products from ceramics

ISO 10993-15, Biological evaluation of medical devices — Part 15: Identification and quantification of

degradation products from metals and alloys

ISO 10993-16, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for

degradation products and leachables

ISO 10993-17, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for

leachable substances

ISO 10993-18, Biological evaluation of medical devices — Part 18: Chemical characterization of materials

ISO/TS 10993-20, Biological evaluation of medical devices — Part 20: Principles and methods for

immunotoxicology testing of medical devices

ISO 14971:2007, Medical devices — Application of risk management to medical devices

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at https: //www .iso .org/obp
3.1
biocompatibility

ability of a medical device (3.14) or material (3.12) to perform with an appropriate host response in a

specific application
3.2
biological risk

combination of the probability of harm to health occurring as a result of adverse reactions associated

with medical device (3.14) or material (3.12) interactions, and the severity of that harm

2 © ISO 2018 – All rights reserved
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SIST EN ISO 10993-1:2021
ISO 10993-1:2018(E)
3.3
biological safety

freedom from unacceptable biological risk (3.2) in the context of the intended use

3.4
chemical constituent

any synthetic or natural substance that is used in a process for manufacturing materials (3.12) and/

or medical devices (3.14), including the base material(s), additives (antioxidants, UV stabilizers, color

additives, dyes, etc.), and processing aids (solvents, lubricants, antifoaming agents, etc.)

3.5
data set

information, such as physical and/or chemical characterization, toxicity data, etc. from a variety of

sources necessary to characterize the biological response to a medical device
3.6
direct contact

medical device (3.14) or medical device component that comes into physical contact with body tissue

3.7
externally communicating medical device

medical device (3.14) or medical device component that is partially or wholly located outside the body

but has either direct or indirect contact with the internal body fluids and/or tissues

3.8
final product

medical device (3.14) or medical device component that has been subjected to all manufacturing

processes for the “to be marketed” medical device including packaging and if applicable, sterilization

3.9
geometry
device configuration
shape and relative arrangement of the parts of the medical device (3.14)
3.10
implant

medical device (3.14) which is intended to be totally introduced into the human body or to replace an

epithelial surface or the surface of the eye by means of clinical intervention and which is intended to

remain in place after the procedure
3.11
indirect contact

medical device (3.14) or medical device component through which a fluid or gas passes, prior to the fluid

or gas coming into physical contact with body tissue (in this case the medical device or medical device

component itself does not physically contact body tissue)
3.12
material

synthetic or natural polymer, metal or alloy, ceramic, or composite, including tissue rendered non-

viable, used as a medical device (3.14) or any part thereof
3.13
material characterization

broad and general process of collecting existing information about a material’s chemistry, structure

and other properties, and if appropriate, new data, to facilitate the evaluation of these properties

3.14
medical device

any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,

material (3.12) or other similar or related article, intended by the manufacturer to be used, alone or in

combination, for human beings, for one or more of the specific medical purpose(s) of:

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SIST EN ISO 10993-1:2021
ISO 10993-1:2018(E)
— diagnosis, prevention, monitoring, treatment or alleviation of disease;

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

— investigation, replacement, modification, or support of the anatomy or of a physiological process;

— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;

— providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic

means, in or on the human body, but which may be assisted in its intended function by such means.

Medical devices include dental devices.

Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others

include:
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies;

[SOURCE: GHTF/SG1/N071: 2012, 5.1 modified to clarify that dental devices are included]

3.15
nanomaterial

material (3.12) with any external dimension in the nanoscale or having internal structure or surface

structure in the nanoscale

[SOURCE: ISO/TR 10993-22:2017, 3. 7, modified — Notes to entry have been deleted.]

3.16
non-contacting

indicates that the medical device (3.14) or medical device component has neither d

...

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