SIST EN ISO 10993-23:2021

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation by using an in vitro reconstructed human epidermis model.

Biologische Beurteilung von Medizinprodukten - Teil 23: Prüfungen auf Irritation (ISO 10993-23:2021)

Dieses Dokument legt das Verfahren für die Bewertung von Medizinprodukten und ihren Bestandteilen hinsichtlich ihres Potentials, eine Irritation hervorzurufen, fest. Die Prüfungen wurden so entwickelt, dass das Irritationspotential von Medizinprodukten, ihren Werkstoffen oder Extrakten nach ISO 10993 1 und ISO 10993 2 vorhergesagt und klassifiziert werden kann.
Dieses Dokument beinhaltet:
—   vor der Prüfung durchzuführende Überlegungen hinsichtlich einer Irritation, einschließlich In silico  und In vitro-Verfahren zur dermalen Exposition;
—   Einzelheiten zur Durchführung von In vitro  und In vivo-Irritationsprüfungen;
—   Schlüsselfaktoren für die Interpretation der Ergebnisse.

Évaluation biologique des dispositifs médicaux - Partie 23: Essais d'irritation (ISO 10993-23:2021)

Le présent document spécifie le mode opératoire pour l'évaluation du potentiel des dispositifs médicaux et de leurs matériaux constitutifs à provoquer une irritation. Les essais sont conçus pour prédire et classer le potentiel d'irritation des dispositifs médicaux, des matériaux ou de leurs extraits conformément à l'ISO 10993‑1 et à l'ISO 10993‑2.
Le présent document comprend :
—          les considérations préalables à la réalisation des essais d'irritation, y compris des méthodes in silico et in vitro d'exposition cutanée ;
—          les informations détaillées relatives aux modes opératoires d'essai d'irritation in vitro et in vivo ;
—          les facteurs clés pour l'interprétation des résultats.

Biološko ovrednotenje medicinskih pripomočkov - 23. del: Preskusi draženja (ISO 10993-23:2021)

General Information

• Status: Published
• Public Enquiry End Date: 19-Jul-2019
• Publication Date: 24-May-2021
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 14-Apr-2021
• Due Date: 19-Jun-2021
• Completion Date: 25-May-2021
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• 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 10993-23:2021 - Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-23:2021
01-julij-2021
Biološko ovrednotenje medicinskih pripomočkov - 23. del: Preskusi draženja (ISO
10993-23:2021)

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-

23:2021)

Biologische Beurteilung von Medizinprodukten - Teil 23: Prüfungen auf Irritation (ISO

10993-23:2021)

Évaluation biologique des dispositifs médicaux - Partie 23: Essais d'irritation (ISO 10993-

23:2021)
Ta slovenski standard je istoveten z: EN ISO 10993-23:2021
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
SIST EN ISO 10993-23:2021 en

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

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SIST EN ISO 10993-23:2021
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SIST EN ISO 10993-23:2021
EN ISO 10993-23
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2021
EUROPÄISCHE NORM
ICS 11.100.20
English Version
Biological evaluation of medical devices - Part 23: Tests for
irritation (ISO 10993-23:2021)

Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil

23: Essais d'irritation (ISO 10993-23:2021, Version 23: Prüfungen auf Irritation (ISO 10993-23:2021)

corrigée inclus 2021-02)
This European Standard was approved by CEN on 1 October 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

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-23:2021 E

worldwide for CEN national Members.
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SIST EN ISO 10993-23:2021
EN ISO 10993-23:2021 (E)
Contents Page

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

Annex ZA (informative) Relationship between this European Standard and the essential

requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered ...................................... 5

Annex ZB (informative) Relationship between this European Standard and the essential

requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered .................................... 7

Annex ZC (informative) Relationship between this European standard and the General

Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be

covered................................................................................................................................................................ 9

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SIST EN ISO 10993-23:2021
EN ISO 10993-23:2021 (E)
European foreword

This document (EN ISO 10993-23:2021) 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 September 2021, and conflicting national standards

shall be withdrawn at the latest by September 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 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 Directive(s).

For the relationship with EU Directive(s) see informative Annex ZA, ZB and ZC, which are integral parts

of this document.

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 standard ‘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.
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SIST EN ISO 10993-23:2021
EN ISO 10993-23:2021 (E)

Table — Correlations between undated normative references and dated EN and ISO standards

Equivalent dated standard
Normative references as listed in
Clause 2 of the ISO standard
EN ISO or IEC
ISO 10993-1 EN ISO 10993-1:2021 ISO 10993-1:2018
ISO 10993-2 EN ISO 10993-2:2006 ISO 10993-2:2006
ISO 10993-9 EN ISO 10993-9:2021 ISO 10993-9:2019
ISO 10993-12 EN ISO 10993-12:2021 ISO 10993-12:2020
ISO 10993-13 EN ISO 10993-13:2010 ISO 10993-13:2010
ISO 10993-14 EN ISO 10993-14:2001 ISO 10993-14:2009
ISO 10993-15 EN ISO 10993-15:2021 ISO 10993-15:2019
ISO 10993-18 EN ISO 10993-18:2021 ISO 10993-18:2020
ISO 14155 EN ISO 14155:2020 ISO 14155:2020
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 14971:2012.

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 10993-23:2021 has been approved by CEN as EN ISO 10993-23:2021 without any

modification.
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SIST EN ISO 10993-23:2021
EN ISO 10993-23:2021 (E)
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered

This European Standard has been prepared under a Commission’s joint standardization request

M/BC/CEN/89/9 concerning harmonized standards relating to horizontal aspects in the field of medical

devices to provide one voluntary means of conforming to essential requirements of Council Directive

93/42/EEC of 14 June 1993 concerning medical devices [OJ L 169].

Once this standard is cited in the Official Journal of the European Union under that Directive,

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 essential requirements

of that Directive 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 Directive 93/42/EEC as amended by 2007/47/EC. This

means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’

or ‘removed’, according to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential

Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.

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 an Essential 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 Directive

93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of
Remarks/Notes
Directive 93/42/EEC this EN
ER 7.1 is only partly covered by this
standard, since the standard does not
provide requirements on design and
manufacture. However, this standard
provides a means to assess potential
4, 5, 6, 7, 8 and Annex A, D
irritancy induced by chemical and/or
7.1 (First and second indent)
and E
physical properties of substances used
in the manufacture of medical devices.
Other forms of toxicity and
flammability are not covered.
ER 7.2 is only partly covered by this
standard, since the standard does not
provide requirements on design,
4, 5, 6, 7, 8 and Annex A, D
7.2
manufacture and packaging and does
and E
not oblige to minimize risk. However,
this standard provides a means to
assess irritancy to contaminants and
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SIST EN ISO 10993-23:2021
EN ISO 10993-23:2021 (E)
residues in medical devices.
ER 7.5 is only partly covered by this
standard, since the standard does not
provide requirements on design and
manufacture. However, this standard
provides a means to assess irritancy to
4, 5, 6, 7, 8 and Annex A, D
substances leaking from medical
7.5 (First paragraph)
and E
devices. This evaluation can be a
preliminary step for risk minimization.
Other forms of toxicity are not dealt
with in this standard.

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 products falling within the scope of

this standard.
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SIST EN ISO 10993-23:2021
EN ISO 10993-23:2021 (E)
Annex ZB
(informative)
Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered

This European Standard has been prepared under a Commission’s joint standardization request

M/BC/CEN/89/9 concerning harmonized standards relating to horizontal aspects in the field of medical

devices to provide one voluntary means of conforming to essential requirements of 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 [OJ L 189].

Once this standard is cited in the Official Journal of the European Union under that Directive,

compliance with the normative clauses of this standard given in Table ZB.1 confers, within the limits of

the scope of this standard, a presumption of conformity with the corresponding essential requirements

of that Directive 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 Directive 90/385/EEC as amended by 2007/47/EC. This

means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’

or ‘removed’, according to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential

Requirements 1, 4, 5, 8, 9 and 10 of the Directive.

NOTE 3 This Annex ZB 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 an Essential Requirement does not appear in Table ZB.1, it means that it is not addressed by this

European Standard.

Table ZB.1 — Correspondence between this European Standard and Annex I of Directive

90/385/EEC [OJ L 189]
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 90/385/EEC this EN
ER 9 is only partly covered by this
standard, since the standard does not
provide requirements on design and
manufacture.
However, this standard provides a
4, 5, 6, 7, 8 and Annex A, D
9 (only first and second indent) means to assess potential irritancy
and E
induced by chemical and/or physical
properties of substances used in the
manufacture of medical devices.
Other forms of toxicity and
flammability are not covered.

General Note: Presumption of conformity depends on also complying with the relevant parts of the ISO 10993

series.
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SIST EN ISO 10993-23:2021
EN ISO 10993-23:2021 (E)

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 products falling within the scope of

this standard.
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SIST EN ISO 10993-23:2021
EN ISO 10993-23:2021 (E)
Annex ZC
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 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 ZC.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 ZC 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 ZC.1, it means that it is

not addressed by this European Standard.
Table ZC.1 — Correspondence between this European Standard and
Annex I of Regulation (EU) 2017/745 [OJ L 117]
General Safety and Performance
Clause(s)/sub-clause(s) of
Requirements of Regulation Remarks/Notes
this EN
(EU) 2017/745
10.1 is only partly covered by EN ISO
10993-23, since the standard does not
provide requirements on design and
manufacture. However, this standard
provides a means to assess potential
irritancy induced by chemical and/or
10.1 a), b), g) and h) 4, 5, 6, 7, 8 and Annex A, D and E
physical properties of substances used
in the manufacture of medical devices.
Other forms of toxicity and flammability
(10.1 a) and b) are not covered.
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SIST EN ISO 10993-23:2021
EN ISO 10993-23:2021 (E)
10.2 is only partly covered by this
standard, since the standard does not
provide requirements on design,
manufacture and packaging and does
10.2 4, 5, 6, 7, 8 and Annex A, D and E
not oblige to minimize risk. However,
this standard provides a means to
assess irritancy to contaminants and
residues in medical devices.
10.4.1 is only partly covered by this
standard, since the standard does not
provide requirements on design and
manufacture. However, this standard
provides a means to assess irritancy to
10.4.1 (First paragraph, first
substances leaking from medical
4, 5, 6, 7, 8 and Annex A, D and E
sentence)
devices. This evaluation can be a
preliminary step for risk minimization.
Other forms of toxicity are not dealt
with in this standard.

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.
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SIST EN ISO 10993-23:2021
INTERNATIONAL ISO
STANDARD 10993-23
First edition
2021-01
Biological evaluation of medical
devices —
Part 23:
Tests for irritation
Évaluation biologique des dispositifs médicaux —
Partie 23: Essais d'irritation
Reference number
ISO 10993-23:2021(E)
ISO 2021
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SIST EN ISO 10993-23:2021
ISO 10993-23:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 10993-23:2021
ISO 10993-23:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 General principles — Step-wise approach ................................................................................................................................ 3

5 Pre-test considerations ................................................................................................................................................................................. 4

5.1 General ........................................................................................................................................................................................................... 4

5.2 Types of material................................................................................................................................................................................... 5

5.2.1 Initial considerations ................................................................................................................................................... 5

5.2.2 Ceramics, metals and alloys ................................................................................................................................... 5

5.2.3 Polymers ................................................................................................................................................................................. 5

5.2.4 Biologically derived materials .............................................................................................................................. 5

5.3 Information on chemical composition ............................................................................................................................... 5

5.3.1 General...................................................................................................................................................................................... 5

5.3.2 Existing data sources ................................................................................................................................................... 5

6 In vitro irritation tests .................................................................................................................................................................................... 6

6.1 General ........................................................................................................................................................................................................... 6

6.2 In vitro reconstructed human epidermis model ....................................................................................................... 6

6.2.1 Test system — Reconstructed human epidermis model ............................................................... 6

6.2.2 Principle of the method ............................................................................................................................................. 6

6.2.3 Prediction model.............................................................................................................................................................. 7

6.3 Materials ....................................................................................................................................................................................................... 8

6.3.1 Reconstructed human epidermis models — Product description ....................................... 8

6.3.2 Preparation of medical device extracts ........................................................................................................ 8

6.4 Methods ......................................................................................................................................................................................................... 9

6.4.1 General...................................................................................................................................................................................... 9

6.4.2 Test procedure ................................................................................................................................................................... 9

6.4.3 Media and end point solutions .........................................................................................................................10

6.4.4 Test sample and control preparation ..........................................................................................................10

6.5 Considerations for test performance ................................................................................................................................11

6.5.1 Receipt of the reconstructed human epidermis tissues..............................................................11

6.5.2 Preparation and pre-incubation ......................................................................................................................11

6.6 Application of the test sample and rinsing ..................................................................................................................11

6.6.1 General...................................................................................................................................................................................11

6.6.2 Preparation ........................................................................................................................................................................12

6.6.3 Test extract and controls exposure ...............................................................................................................12

6.7 MTT test for determination of RhE tissue viability after the exposure period ............................13

6.7.1 MTT incubation and Isopropanol extraction ........................................................................................13

6.7.2 Absorbance measurements .................................................................................................................................13

6.8 Test acceptance criteria ................................................................................................................................................................14

6.9 Data calculation steps ....................................................................................................................................................................14

6.9.1 General...................................................................................................................................................................................14

6.9.2 Isopropanol background control for OD in RhE assay .................................................................14

6.9.3 Negative DPBS or PBS treated controls .....................................................................................................14

6.9.4 Positive control ...................................................................... .........................................................................................14

6.9.5 Tested extract and VC samples (TTs) ..........................................................................................................15

6.10 Data interpretation — Prediction model ......................................................................................................................15

6.11 Method documentation sheet .................................................................................................................................................15

6.12 Test report ................................................................................................................................................................................................16

7 In vivo irritation tests ...................................................................................................................................................................................16

7.1 General ........................................................................................................................................................................................................16

© ISO 2021 – All rights reserved iii
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SIST EN ISO 10993-23:2021
ISO 10993-23:2021(E)

7.2 Animal irritation test by skin exposure ..........................................................................................................................17

7.2.1 Principle .........................................................
...