SIST EN ISO 10993-23:2021
(Main)Biological evaluation of medical devices - Part 23: Tests for irritation (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. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.
This document includes:
— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
— details of in vitro and in vivo irritation test procedures;
— key factors for the interpretation of the results.
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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.
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
a
ISO 10993-1 EN ISO 10993-1:2021 ISO 10993-1:2018
ISO 10993-2 EN ISO 10993-2:2006 ISO 10993-2:2006
a
ISO 10993-9 EN ISO 10993-9:2021 ISO 10993-9:2019
a
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
a
ISO 10993-15 EN ISO 10993-15:2021 ISO 10993-15:2019
a
ISO 10993-18 EN ISO 10993-18:2021 ISO 10993-18:2020
ISO 14155 EN ISO 14155:2020 ISO 14155:2020
a
Under preparation at European level.
NOTE This part of EN ISO 10993 refers to ISO 10993-1 which itself refers to ISO 14971. In Europe, it should
be assumed that the reference to ISO 14971 is to EN ISO 14971:2012.
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.
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
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.
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.
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.
Annex ZC
(informative)
Relationship between this European standard and the General Safety
...
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