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

ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische Toxizität (ISO 10993-11:2017)

Dieses Dokument legt Anforderungen an Verfahren fest und gibt eine Anleitung, die bei der Beurteilung des Potenzials von Materialien für Medizinprodukte zur Auslösung nachteiliger systemischer Reaktionen zu befolgen sind.

Évaluation biologique des dispositifs médicaux - Partie 11: Essais de toxicité systémique (ISO 10993-11:2017)

ISO 10993-11:2017 spécifie des exigences et fournit des préconisations quant aux modes opératoires à suivre pour évaluer les éventuelles réactions systémiques défavorables causées par les matériaux de dispositifs médicaux.

Biološko ovrednotenje medicinskih pripomočkov - 11. del: Preskusi sistemske toksičnosti (ISO 10993-11:2017)

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 vključuje:
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

Status
Published
Publication Date
29-May-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
30-May-2018
Completion Date
30-May-2018

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SLOVENSKI STANDARD
SIST EN ISO 10993-11:2018
01-september-2018
1DGRPHãþD
SIST EN ISO 10993-11:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO3UHVNXVLVLVWHPVNH
WRNVLþQRVWL ,62

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-

11:2017)

Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische

Toxizität (ISO 10993-11:2017)

Évaluation biologique des dispositifs médicaux - Partie 11: Essais de toxicité systémique

(ISO 10993-11:2017)
Ta slovenski standard je istoveten z: EN ISO 10993-11:2018
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-11:2018 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 10993-11:2018
---------------------- Page: 2 ----------------------
SIST EN ISO 10993-11:2018
EN ISO 10993-11
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-11:2009
English Version
Biological evaluation of medical devices - Part 11: Tests for
systemic toxicity (ISO 10993-11:2017)

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

11: Essais de toxicité systémique (ISO 10993-11:2017) 11: Prüfungen auf systemische Toxizität (ISO 10993-

11:2017)
This European Standard was approved by CEN on 31 July 2017.

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, 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

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-11:2018 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 10993-11:2018
EN ISO 10993-11:2018 (E)
Contents Page

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

Endorsement notice ..................................................................................................................................................... 4

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

---------------------- Page: 4 ----------------------
SIST EN ISO 10993-11:2018
EN ISO 10993-11:2018 (E)
European foreword

This document (EN ISO 10993-11:2018) 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 November 2018, and conflicting national standards

shall be withdrawn at the latest by November 2018.

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 10993-11:2009.

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 relationship with EU Directive(s), see informative Annex ZA and ZB, which is an integral part 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 1 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 1 — Correlations between undated normative references and dated EN and ISO standards

Normative references Equivalent dated standard
as listed in Clause 2 of
EN ISO or IEC
the ISO standard
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 10993-2 EN ISO 10993-2:2006 ISO 10993-2:2006

NOTE 2 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, 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.
---------------------- Page: 5 ----------------------
SIST EN ISO 10993-11:2018
EN ISO 10993-11:2018 (E)
Endorsement notice

The text of ISO 10993-11:2017 has been approved by CEN as EN ISO 10993-11:2018 without any

modification.
---------------------- Page: 6 ----------------------
SIST EN ISO 10993-11:2018
EN ISO 10993-11:2018 (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 ISO
10993-11, since the standard does not
provide requirements on design and
manufacture. However, this part of ISO
10993 specifies test methods for the
assessment of systemic toxicity of
materials intended for use in medical
devices. Therefore, this standard
provides a means to evaluate systemic
7.1 (First and second indent) 4, 5 and 6
toxicity risks associated with the
materials which are used.
These tests are not intended to evaluate
or determine the performance of the test
sample in terms of mechanical or
functional loading.
Systemic toxicity studies conducted by
---------------------- Page: 7 ----------------------
SIST EN ISO 10993-11:2018
EN ISO 10993-11:2018 (E)
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 93/42/EEC this EN
implantation may satisfy the
requirements of this part of ISO 10993.
When conducting combined studies for
evaluating local effects and systemic
effects, the requirements of this part of
ISO 10993 and ISO 10993-6 shall be
fulfilled.
For ER 7.1 (first and second indent),
flammability is not covered
ER 7.2 is not covered by ISO 10993-11,
since the standard does not provide
requirements on design, manufacture
and packaging and does not oblige to
minimize risk. However, this part of ISO
10993 specifies test methods for the
assessment of systemic effects arising
7.2 4, 5 and 6
from the exposure of users or patients to
contaminants or residues present in
medical devices. This assessment can be
a preliminary step for risk minimization.
However it does not address risks to
persons involved in the transport or
storage of medical devices.
ER 7.5 is not covered by ISO 10993-11,
since the standard does not provide
requirements on design and manufacture
and does not oblige to minimize risk.
However, this part of ISO 10993 specifies
7.5, first paragraph, first sentence
4, 5 and 6
test methods for the assessment of
only
systemic effects arising from exposure to
substances released by or leaching from
medical 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 all relevant

clauses/subclauses of ISO 10993-1.

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.
---------------------- Page: 8 ----------------------
SIST EN ISO 10993-11:2018
EN ISO 10993-11:2018 (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) Remarks/Notes
Directive 90/385/EEC of this EN
ER 9 is only partly covered by ISO
10993-11, since the standard does
not provide requirements on
design and manufacture. However,
this part of ISO 10993 specifies test
methods for the assessment of
systemic toxicity of materials
9 (only first and second
intended for use in medical
4, 5 and 6
indent)
devices. Therefore, this standard
provides a means to evaluate
systemic toxicity risks associated
with the materials which are used.
These tests are not intended to
evaluate or determine the
---------------------- Page: 9 ----------------------
SIST EN ISO 10993-11:2018
EN ISO 10993-11:2018 (E)
Essential Requirements of Clause(s)/sub-clause(s) Remarks/Notes
Directive 90/385/EEC of this EN
performance of the test sample in
terms of mechanical or functional
loading.
Systemic toxicity studies
conducted by implantation may
satisfy the requirements of this
part of ISO 10993. When
conducting combined studies for
evaluating local effects and
systemic effects, the requirements
of this part of ISO 10993 and
ISO 10993-6 shall be fulfilled.
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 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.
---------------------- Page: 10 ----------------------
SIST EN ISO 10993-11:2018
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
---------------------- Page: 11 ----------------------
SIST EN ISO 10993-11:2018
ISO 10993-10:2010(E)
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Published in Switzerland
ii © ISO 2010 – All rights reserved
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SIST EN ISO 10993-11:2018
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 10993-11:2018
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
---------------------- Page: 14 ----------------------
SIST EN ISO 10993-11:2018
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
---------------------- Page: 15 ----------------------
SIST EN ISO 10993-11:2018
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
---------------------- Page: 16 ----------------------
SIST EN ISO 10993-11:2018
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, Bio
...

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