SIST EN ISO 10993-10:2013
(Main)Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This part of ISO 10993 includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures; c) key factors for the interpretation of the results. Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfung auf Irritation und Hautsensibilisierung (ISO 10993-10:2010)
Évaluation biologique des dispositifs médicaux - Partie 10: Essais d'irritation et de sensibilisation cutanée (ISO 10993-10:2010)
L'ISO 10993-10:2010 décrit le mode opératoire pour l'évaluation du potentiel des dispositifs médicaux et de leurs matériaux constitutifs à provoquer une irritation et une sensibilisation de la peau.
L'ISO 10993-10:2010 comprend
des considérations préalablement aux essais relatives à l'irritation, y compris des méthodes in silico et in vitro d'exposition dermique,
des informations détaillées relatives aux procédures d'essai in vivo (irritation et sensibilisation), et
des facteurs clés pour l'interprétation des résultats.
Des instructions sont fournies en vue de la préparation des matériaux, notamment pour les essais précités et plusieurs essais d'irritation spéciaux pour l'application de dispositifs médicaux dans des zones autres que la peau.
Biološko ovrednotenje medicinskih pripomočkov - 10. del: Preskusi draženja in preobčutljivosti kože (ISO 10993-10:2010)
Ta del standarda ISO 10993 opisuje postopek za presojo medicinskih pripomočkov in njihovih sestavnih materialov glede njihovega potenciala za povzročitev draženja in preobčutljivosti kože. Ta del standarda ISO 10993 zajema: a) premisleke glede draženja pred preskusom, vključno z metodami in silico in in vitro za izpostavljenost kože, b) podrobnosti preskusnih postopkov in vivo (draženje in preobčutljivost), c) ključne dejavnike za razlago rezultatov. V Dodatku A so podana navodila za pripravo materialov, zlasti v zvezi z zgornjimi preskusi. V Dodatku B je opisanih več posebnih preskusov draženja pri uporabi medicinskih pripomočkov na drugih delih telesa (ne na koži).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10993-10:2013
01-november-2013
1DGRPHãþD
SIST EN ISO 10993-10:2010
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO 3UHVNXVLGUDåHQMDLQ
SUHREþXWOMLYRVWLNRåH ,62
Biological evaluation of medical devices - Part 10: Tests for irritation and skin
sensitization (ISO 10993-10:2010)
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfung auf Irritation und
Hautsensibilisierung (ISO 10993-10:2010)
Évaluation biologique des dispositifs médicaux - Partie 10: Essais d'irritation et de
sensibilisation cutanée (ISO 10993-10:2010)
Ta slovenski standard je istoveten z: EN ISO 10993-10:2013
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-10:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10993-10:2013
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SIST EN ISO 10993-10:2013
EUROPEAN STANDARD
EN ISO 10993-10
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2013
ICS 11.100.20 Supersedes EN ISO 10993-10:2010
English Version
Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization (ISO 10993-10:2010)
Évaluation biologique des dispositifs médicaux - Partie 10:
Essais d'irritation et de sensibilisation cutanée (ISO 10993-
10:2010)
This European Standard was approved by CEN on 9 July 2013.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-10:2013: E
worldwide for CEN national Members.
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SIST EN ISO 10993-10:2013
EN ISO 10993-10:2013 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .5
2
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SIST EN ISO 10993-10:2013
EN ISO 10993-10:2013 (E)
Foreword
The text of ISO 10993-10:2010 has been prepared by Technical Committee ISO/TC 194 "Biological evaluation
of medical devices” of the International Organization for Standardization (ISO) and has been taken over as EN
ISO 10993-10:2013 by Technical Committee CEN/TC 206 “Biological evaluation of medical devices” the
secretariat of which is held by NEN.
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 February 2014, and conflicting national standards shall be withdrawn
at the latest by February 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10993-10:2010.
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 Directives.
For relationship with EU Directives, see informative Annex ZA and ZB, which are integral parts of this
document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10993-10:2010 has been approved by CEN as EN ISO 10993-10:2013 without any
modification.
3
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SIST EN ISO 10993-10:2013
EN ISO 10993-10:2013 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on Medical Devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
International Standard given in Table ZA.1 confers, within the limits of the scope of this European Standard, a
presumption of conformity with the corresponding Essential Requirements of that Directive and associated
EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
Clause(s)/sub-clause(s) of this Essential Requirements Qualifying remarks/Notes
European Standard (ERs) of Directive 93/42/EEC
ER 7.1 is only partly covered by EN ISO
4, 5, 6, 7, 8, Annexes A, B and C 7.1 first and second indents
10993-10, since the standard does not
only
provide requirements on design and
manufacture. However, this standard
provides a means to assess irritancy
and skin sensitization to 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 EN ISO
4, 5, 6, 7, 8, Annexes A, B and C 7.2
10993-10, since the standard does not
provide requirements on design,
manufacture and packaging. However,
this standard provides a means to assess
irritancy and skin sensitization to
contaminants and residues in medical
devices.
ER 7.5 is only partly covered by EN ISO
4, 5, 6, 7, 8, Annexes A, B and C 7.5 first sentence of the first
10993-10, since the standard does not
paragraph only.
provide requirements on design and
manufacture. However, this standard
provides a means to assess irritancy
and skin sensitization to substances
leaking from medical devices
General Note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of
EN ISO 10993-1.
WARNING — Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
4
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SIST EN ISO 10993-10:2013
EN ISO 10993-10:2013 (E)
Annex ZB
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 90/385/EEC on Active Implantable Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on active Implantable Medical Devices.
Once this Standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
International 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.
Table ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC on Active
Implantable Medical Devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
European Standard of Directive 90/385/EEC
4, 5, 6, 7, 8, Annexes A, B and C 9, first and second indents only ER 9 is only partly covered by
EN ISO 10993-10, since the
standard does not provide
requirements on design and
manufacture. However, this
standard provides a means to
assess irritancy and skin
sensitization to substances used
in the manufacture of medical
devices. Other forms of toxicity
are not covered.
General Note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of
ISO 10993-1.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
5
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SIST EN ISO 10993-10:2013
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SIST EN ISO 10993-10:2013
INTERNATIONAL ISO
STANDARD 10993-10
Third edition
2010-08-01
Biological evaluation of medical
devices —
Part 10:
Tests for irritation and skin sensitization
Évaluation biologique des dispositifs médicaux —
Partie 10: Essais d'irritation et de sensibilisation cutanée
Reference number
ISO 10993-10:2010(E)
©
ISO 2010
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SIST EN ISO 10993-10:2013
ISO 10993-10:2010(E)
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ii © ISO 2010 – All rights reserved
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SIST EN ISO 10993-10:2013
ISO 10993-10:2010(E)
Contents Page
Foreword .iv
Introduction.vi
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 General principles — Step-wise approach .4
5 Pretest considerations.4
5.1 General .4
5.2 Types of material .5
5.3 Information on chemical composition .5
6 Irritation tests.6
6.1 In vitro irritation tests.6
6.2 In vivo irritation tests — Factors to be considered in design and selection of in vivo tests .6
6.3 Animal irritation test.7
6.4 Animal intracutaneous (intradermal) reactivity test .11
6.5 Human skin irritation test .14
7 Skin sensitization tests.15
7.1 Choice of test methods.15
7.2 Murine Local Lymph Node Assay (LLNA).15
7.3 Guinea pig assays for the detection of skin sensitization.18
7.4 Important factors affecting the outcome of the test .19
7.5 Guinea pig maximization test (GPMT).20
7.6 Closed-patch test (Buehler test) .23
8 Key factors in interpretation of test results.26
Annex A (normative) Preparation of materials for irritation/sensitization testing.27
Annex B (normative) Special irritation tests.29
Annex C (normative) Human skin irritation test .44
Annex D (informative) In vitro tests for skin irritation.48
Annex E (informative) Method for the preparation of extracts from polymeric test materials .54
Annex F (informative) Background information .57
Bibliography.61
© ISO 2010 – All rights reserved iii
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SIST EN ISO 10993-10:2013
ISO 10993-10:2010(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 10993-10 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.
This third edition cancels and replaces the second edition (ISO 10993-10:2002), which has been technically
revised.
ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices:
⎯ Part 1: Evaluation and testing within a risk management process
⎯ Part 2: Animal welfare requirements
⎯ Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
⎯ Part 4: Selection of tests for interactions with blood
⎯ Part 5: Tests for in vitro cytotoxicity
⎯ Part 6: Tests for local effects after implantation
⎯ Part 7: Ethylene oxide sterilization residuals
⎯ Part 9: Framework for identification and quantification of potential degradation products
⎯ Part 10: Tests for irritation and skin sensitization
⎯ Part 11: Tests for systemic toxicity
⎯ Part 12: Sample preparation and reference materials
⎯ Part 13: Identification and quantification of degradation products from polymeric medical devices
⎯ Part 14: Identification and quantification of degradation products from ceramics
⎯ Part 15: Identification and quantification of degradation products from metals and alloys
iv © ISO 2010 – All rights reserved
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SIST EN ISO 10993-10:2013
ISO 10993-10:2010(E)
⎯ Part 16: Toxicokinetic study design for degradation products and leachables
⎯ Part 17: Establishment of allowable limits for leachable substances
⎯ Part 18: Chemical characterization of materials
⎯ Part 19: Physico-chemical, morphological and topographical characterization of materials [Technical
Specification]
⎯ Part 20: Principles and methods for immunotoxicology testing of medical devices [Technical Specification]
© ISO 2010 – All rights reserved v
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SIST EN ISO 10993-10:2013
ISO 10993-10:2010(E)
Introduction
This part of ISO 10993 assesses possible contact hazards from chemicals released from medical devices,
which may produce skin and mucosal irritation, eye irritation or skin sensitization.
Some materials that are included in medical devices have been tested, and their skin or mucosal irritation or
sensitization potential has been documented. Other materials and their chemical components have not been
tested and may induce adverse effects when in contact with human tissue. The manufacturer is thus obliged
to evaluate each device for potential adverse effects prior to marketing.
Traditionally, small animal tests are performed prior to testing on humans to help predict human response.
More recently, in vitro tests as well as human tests have been added as adjuncts or alternatives. Despite
progress and considerable effort in this direction, a review of findings suggests that currently no satisfactory
in vitro test has been devised to eliminate the requirement for in vivo testing. Where appropriate, the
preliminary use of in vitro methods is encouraged for screening purposes prior to animal testing. In order to
reduce the number of animals used, this part of ISO 10993 presents a step-wise approach, with review and
analysis of test results at each stage. An animal test is usually required prior to human testing.
It is intended that these studies be conducted using Good Laboratory Practice and comply with regulations
related to animal welfare. Statistical analysis of data is recommended and should be used whenever
appropriate.
This part of ISO 10993 is intended for use by professionals, appropriately qualified by training and experience,
who are able to interpret its requirements and judge the outcomes of the evaluation for each medical device,
taking into consideration all the factors relevant to the device, its intended use and the current knowledge of
the medical device provided by review of the scientific literature and previous clinical experience.
The tests included in this part of ISO 10993 are important tools for the development of safe products, provided
that these are executed and interpreted by trained personnel.
This part of ISO 10993 is based on numerous standards and guidelines, including OECD Guidelines,
U.S. Pharmacopoeia and the European Pharmacopoeia. It is intended to be the basic document for the
selection and conduct of tests enabling evaluation of irritation and dermal sensitization responses relevant to
safety of medical materials and devices.
vi © ISO 2010 – All rights reserved
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SIST EN ISO 10993-10:2013
INTERNATIONAL STANDARD ISO 10993-10:2010(E)
Biological evaluation of medical devices —
Part 10:
Tests for irritation and skin sensitization
1 Scope
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent
materials with regard to their potential to produce irritation and skin sensitization.
This part of ISO 10993 includes:
a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
b) details of in vivo (irritation and sensitization) test procedures;
c) key factors for the interpretation of the results.
Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In
Annex B several special irritation tests are described for application of medical devices in areas other than skin.
2 Normative references
The following referenced documents are indispensable for the application 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 10993-1:2009, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-9, Biological evaluation of medical devices — Part 9: Framework for identification and
quantification of potential degradation products
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 10993-18, Biological evaluation of medical devices — Part 18: Chemical characterization of materials
ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
© ISO 2010 – All rights reserved 1
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SIST EN ISO 10993-10:2013
ISO 10993-10:2010(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply.
3.1
allergen
sensitizer
substance or material that is capable of inducing a specific hypersensitivity reaction upon repeated contact
with that substance or material
3.2
blank
extraction vehicle not containing the test material, retained in a vessel identical to that which holds the test
material and subjected to identical conditions to which the test material is subjected during its extraction
NOTE The purpose of the blank control is to evaluate possible confounding effects due to the extraction vessel,
vehicle and extraction process.
3.3
challenge
elicitation
process following the induction phase, in which the immunological effects of subsequent exposures in an
individual to the inducing material are examined
3.4
dose
dosage
amount of test sample administered (e.g. mass, volume) expressed per unit of body weight or surface area
NOTE The terms are often used interchangeably (more commonly dosage).
3.5
erythema
reddening of the skin or mucous membrane
3.6
eschar
scab or discoloured slough of skin
3.7
extract
liquid or suspension that results from exposing a test or control material to a solvent under controlled
conditions
3.8
induction
process that leads to the de novo generation of an enhanced state of immunological activity in an individual, to
a specific material
3.9
irritant
agent that produces irritation
3.10
irritation
localized non-specific inflammatory response to single, repeated or continuous application of a substance/material
NOTE Skin irritation is a reversible reaction and is mainly characterized by local erythema (redness) of the skin.
2 © ISO 2010 – All rights reserved
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SIST EN ISO 10993-10:2013
ISO 10993-10:2010(E)
3.11
necrosis
cell death as a direct result of irreversible changes caused by injury or disease
NOTE One should be aware that tissue repair will occur either resulting in complete functional restoration or resulting
in scar formation.
3.12
negative control
any well-characterized material or substance that, when tested by a specific procedure, demonstrates the
suitability of the procedure to yield a reproducible, appropriately negative, non-reactive or minimal response in
the test system
NOTE In practice, negative controls include blanks, vehicles/solvents and reference materials.
3.13
oedema
swelling due to abnormal infiltration of fluid into the tissues
3.14
positive control
any well-characterized material or substance that, when evaluated by a specific test method, demonstrates
the suitability of the test system to yield a reproducible, appropriately positive or reactive response in the test
system
3.15
skin corrosion
production of irreversible damage to the skin, manifested as visible necrosis through the epidermis and into
the dermis, following application of a test sample
EXAMPLE The action of a compound/chemical/test sample resulting in ulceration of skin (see 3.19).
3.16
skin sensitization
allergic contact dermatitis
immunologically mediated cutaneous reaction to a substance
NOTE In the human, the responses can be characterized by pruritis, erythema, oedema, papules, vesicles, bullae or
a combination of these. In other species the reactions can differ and only erythema and oedema can be seen.
3.17
test material
material, device, device portion or component thereof that is sampled for biological or chemical testing
3.18
test sample
material, device, device portion, component, extract or portion thereof that is subjected to biological or
chemical testing or evaluation
3.19
ulceration
open sore representing loss of superficial tissue
3.20
vehicle
liquid used to moisten, dilute, suspend, extract or dissolve the test substance/material
© ISO 2010 – All rights reserved 3
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SIST EN ISO 10993-10:2013
ISO 10993-10:2010(E)
4 General principles — Step-wise approach
The available methods for testing irritation and sensitization were developed specifically to detect skin and
mucous membrane irritation and skin sensitization potential. Other types of adverse effect are generally not
predicted by these tests. For medical devices that are used as implants or external communicating devices,
intradermal testing is more relevant in approaching the application and so for detection of irritation activity,
intracutaneous testing shall be used as described in 6.4.
This part of ISO 10993 requires a step-wise approach, which
...
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