Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)

This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

Zahnheilkunde - Beurteilung der Biokompatibilität von in der Zahnheilkunde verwendeten Medizinprodukten (ISO 7405:2018)

Médecine bucco-dentaire - Évaluation de la biocompatibilité des dispositifs médicaux utilisés en médecine bucco-dentaire (ISO 7405:2018)

Le présent document spécifie des méthodes d'essai pour l'évaluation des effets biologiques des dispositifs médicaux utilisés en médecine bucco-dentaire. Il inclut des essais de produits pharmacologiques qui font partie intégrante du dispositif soumis à essai.
Le présent document ne couvre pas les essais des matériaux et des dispositifs qui n'entrent pas en contact direct ou indirect avec le corps du patient.

Zobozdravstvo - Ovrednotenje biokompatibilnosti medicinskih pripomočkov v zobozdravstvu (ISO 7405:2018)

Ta dokument določa preskusne metode za ovrednotenje bioloških učinkov medicinskih pripomočkov v zobozdravstvu. Vključuje preskušanje farmakoloških agentov, ki so ključen del pripomočka, ki se preskuša.
Ta dokument ne zajema preskušanja materialov in pripomočkov, ki ne prihajajo v neposreden ali posreden
stik z bolnikovim telesom.

General Information

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

RELATIONS

Buy Standard

Standard
EN ISO 7405:2019
English language
52 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 7405:2019
01-januar-2019
1DGRPHãþD
SIST EN ISO 7405:2009
SIST EN ISO 7405:2009/A1:2013
=RER]GUDYVWYR2YUHGQRWHQMHELRNRPSDWLELOQRVWLPHGLFLQVNLKSULSRPRþNRYY
]RER]GUDYVWYX ,62

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO

7405:2018)

Zahnheilkunde - Beurteilung der Biokompatibilität von in der Zahnheilkunde verwendeten

Medizinprodukten (ISO 7405:2018)

Médecine bucco-dentaire - Évaluation de la biocompatibilité des dispositifs médicaux

utilisés en médecine bucco-dentaire (ISO 7405:2018)
Ta slovenski standard je istoveten z: EN ISO 7405:2018
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 7405:2019 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 7405:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 7405:2019
EN ISO 7405
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2018
EUROPÄISCHE NORM
ICS 11.060.10; 11.100.99 Supersedes EN ISO 7405:2008
English Version
Dentistry - Evaluation of biocompatibility of medical
devices used in dentistry (ISO 7405:2018)

Médecine bucco-dentaire - Évaluation de la Zahnheilkunde - Beurteilung der Biokompatibilität von

biocompatibilité des dispositifs médicaux utilisés en in der Zahnheilkunde verwendeten Medizinprodukten

médecine bucco-dentaire (ISO 7405:2018) (ISO 7405:2018)
This European Standard was approved by CEN on 17 August 2018.

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 7405:2018 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 7405:2019
EN ISO 7405:2018 (E)
Contents Page

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

---------------------- Page: 4 ----------------------
SIST EN ISO 7405:2019
EN ISO 7405:2018 (E)
European foreword

This document (EN ISO 7405:2018) has been prepared by Technical Committee ISO/TC 106 "Dentistry"

in collaboration with Technical Committee CEN/TC 55 “Dentistry” 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 May 2019, and conflicting national standards shall be

withdrawn at the latest by May 2019.

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 7405:2008.

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 7405:2018 has been approved by CEN as EN ISO 7405:2018 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 7405:2019
---------------------- Page: 6 ----------------------
SIST EN ISO 7405:2019
INTERNATIONAL ISO
STANDARD 7405
Third edition
2018-10
Corrected version
2018-12
Dentistry — Evaluation of
biocompatibility of medical devices
used in dentistry
Médecine bucco-dentaire — Évaluation de la biocompatibilité des
dispositifs médicaux utilisés en médecine bucco-dentaire
Reference number
ISO 7405:2018(E)
ISO 2018
---------------------- Page: 7 ----------------------
SIST EN ISO 7405:2019
ISO 7405:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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

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

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

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 7405:2019
ISO 7405:2018(E)
Contents Page

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

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

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

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

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Categorization of medical devices ...................................................................................................................................................... 2

4.1 Categorization by nature of contact ...................................................................................................................................... 2

4.1.1 General...................................................................................................................................................................................... 2

4.1.2 Non-contact devices ...................................................................................................................................................... 3

4.1.3 Surface-contacting devices ..................................................................................................................................... 3

4.1.4 External communicating devices ....................................................................................................................... 3

4.1.5 Implant devices used in dentistry ..................................................................................................................... 3

4.2 Categorization by duration of contact ................................................................................................................................ 3

4.2.1 General...................................................................................................................................................................................... 3

4.2.2 Limited exposure devices ......................................................................................................................................... 3

4.2.3 Prolonged exposure devices .................................................................................................................................. 3

4.2.4 Permanent contact devices ..................................................................................................................................... 4

5 Biological evaluation process ................................................................................................................................................................. 4

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

5.2 Selection of tests and overall assessment ........................................................................................................................ 4

5.3 Selection of test methods ............................................................................................................................................................... 4

5.4 Types of test .............................................................................................................................................................................................. 5

5.4.1 General...................................................................................................................................................................................... 5

5.4.2 Physical and chemical characterization ....................................................................................................... 5

5.4.3 Group I ...................................................................................................................................................................................... 5

5.4.4 Group II .................................................................................................................................................................................... 5

5.4.5 Group III .................................................................................................................................................................................. 6

5.5 Re-evaluation of biocompatibility .......................................................................................................................................... 6

6 Test procedures specific to dental materials .......................................................................................................................... 6

6.1 Recommendations for sample preparation ................................................................................................................... 6

6.1.1 General...................................................................................................................................................................................... 6

6.1.2 General recommendations for sample preparation .......................................................................... 6

6.1.3 Specific recommendations for light curing materials ...................................................................... 7

6.1.4 Specific recommendations for chemically setting materials ..................................................... 8

6.1.5 Positive control material ........................................................................................................................................... 8

6.2 Agar diffusion test ................................................................................................................................................................................ 8

6.2.1 Objective ...................................................................... ............................................................................................................ 8

6.2.2 Cell line ..................................................................................................................................................................................... 8

6.2.3 Culture medium, reagents and equipment ................................................................................................ 8

6.2.4 Sample preparation ....................................................................................................................................................... 9

6.2.5 Controls .................................................................................................................................................................................... 9

6.2.6 Test procedure ................................................................................................................................................................... 9

6.2.7 Parameters of assessment ....................................................................................................................................... 9

6.2.8 Assessment of results ...............................................................................................................................................10

6.2.9 Test report ..........................................................................................................................................................................11

6.3 Filter diffusion test ...........................................................................................................................................................................11

6.3.1 Objective ...................................................................... .........................................................................................................11

6.3.2 Cell line ..................................................................................................................................................................................11

6.3.3 Culture medium, reagents and equipment .............................................................................................11

6.3.4 Sample preparation ....................................................................................................................................................11

6.3.5 Controls .................................................................................................................................................................................12

6.3.6 Test procedure ................................................................................................................................................................12

© ISO 2018 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 7405:2019
ISO 7405:2018(E)

6.3.7 Assessment of cell damage...................................................................................................................................12

6.3.8 Assessment of results ...............................................................................................................................................13

6.3.9 Test report ..........................................................................................................................................................................13

6.4 Pulp and dentine usage test ......................................................................................................................................................13

6.4.1 Objective ...................................................................... .........................................................................................................13

6.4.2 Animals and animal welfare ................................................................................................................................13

6.4.3 Test procedure ................................................................................................................................................................14

6.4.4 Assessment of results ...............................................................................................................................................19

6.4.5 Test report ..........................................................................................................................................................................19

6.5 Pulp capping test ................................................................................................................................................................................19

6.5.1 Objective ...................................................................... .........................................................................................................19

6.5.2 Animals and animal welfare ................................................................................................................................19

6.5.3 Test procedure ................................................................................................................................................................20

6.5.4 Assessment of results ...............................................................................................................................................22

6.5.5 Test report ..........................................................................................................................................................................22

6.6 Endodontic usage test ....................................................................................................................................................................22

6.6.1 Objective ...................................................................... .........................................................................................................22

6.6.2 Animals and animal welfare ................................................................................................................................22

6.6.3 Test procedure ................................................................................................................................................................22

6.6.4 Assessment of results ...............................................................................................................................................24

6.6.5 Test report ..........................................................................................................................................................................25

Annex A (informative) Types of test to be considered for evaluation of biocompatibility of

medical devices used in dentistry ...................................................................................................................................................26

Annex B (informative) Dentine barrier cytotoxicity test ..............................................................................................................29

Annex C (informative) Endosseous dental implant usage test ...............................................................................................37

Bibliography .............................................................................................................................................................................................................................41

iv © ISO 2018 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 7405:2019
ISO 7405:2018(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry.

This third edition of ISO 7405 cancels and replaces ISO 7405:2008 and ISO/TS 22911:2016 which have

been technically revised. It also incorporates the Amendment ISO 7405:2008/Amd.1:2013.

The main changes compared to the previous edition are as follows:

— as crucial first step in the biological evaluation a material characterization is required before

biological tests are conducted (see 5.4.2)

— modifications of contents of ‘pulp and dentine usage test’ and ‘endodontic test’

— deletion of Annex C (Acute toxicity testing);
— addition of ISO/TS 22911 as new Annex C.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
This corrected version of ISO 7405:2018 incorporates the following corrections.
rd rd

—In Table A.1, 3 row, 3 column for “Physical and/or chemical data”, “ISO 10993-18” and “ISO/

TS 10993-19” have been added.
rd th

—In Table A.1, 3 row, 5 column for “Cytotoxicity tests”, “ISO 10993-5” has been added.

rd th

—In Table A.1, 3 row, 11 column for “Genotoxicity”, “ISO 10993-3” has been added.

© ISO 2018 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 7405:2019
ISO 7405:2018(E)
Introduction

This document describes the evaluation of the biocompatibility of medical devices used in dentistry. It is

to be used in conjunction with the ISO 10993 series of standards. This document contains special tests,

for which ample experience exists in dentistry and which acknowledge the special needs of dentistry.

Only test methods for which the members of the committee considered there was sufficient published

data have been included. In recommending test methods, the need to minimize the number and exposure

of test animals was given a high priority. It is essential that the decision to undertake tests involving

animals be reached only after a full and careful review of the evidence indicating that a similar outcome

cannot be achieved by other types of test. In order to keep the number of animals required for tests

to an absolute minimum, consistent with achieving the objective indicated, it can be appropriate to

conduct more than one type of test on the same animal at the same time, e.g. pulp and dentine usage

test and pulp capping test. However, in accordance with ISO 10993-2 these tests are performed both

in an efficient and humane way. On all occasions when animal testing is undertaken, such tests are

conducted empathetically and according to standardized procedures as described for each test.

This document does not explicitly describe test methods for occupationally related risks.

Annex B is included to encourage the development of in vitro and ex vivo test methods which will further

reduce the use of animals in the evaluation of the biocompatibility of medical devices used in dentistry.

Annex C is based on and replaces ISO/TS 22911.
vi © ISO 2018 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 7405:2019
INTERNATIONAL STANDARD ISO 7405:2018(E)
Dentistry — Evaluation of biocompatibility of medical
devices used in dentistry
1 Scope

This document specifies test methods for the evaluation of biological effects of medical devices used in

dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.

This document does not cover testing of materials and devices that do not come into direct or indirect

contact with the patient's body.
2 Normative references

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

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

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

ISO 1942, Dentistry — Vocabulary

ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test

ISO 10993-1, 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 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and

reproductive toxicity

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

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

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

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

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

materials

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

ISO/TS 10993-19, Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and

topographical characterization of materials
ISO 14971, Medical devices — Application of risk management to medical devices

ISO 16443, Dentistry — Vocabulary for dental implants systems and related procedure

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942, ISO 10993-1,

ISO 10993-12, ISO 16443 and the following apply.
© ISO 2018 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 7405:2019
ISO 7405:2018(E)

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

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

material and/or substance or combination of materials and/or substances specially formulated and

prepared for use in the practice of dentistry and/or associated procedures
3.2
final product

medical device or device component that includes all manufacturing processes for the “to be marketed”

device including packaging and sterilization, if applicable, and that includes processes prior to intended

use, such as mixing, preconditioning and preparation
3.3
positive control material

well characterized material and/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
3.4
negative control material

well characterized material and/or substance that, when evaluated by a specific test method,

demonstrates the suitability of the test system to yield a reproducible, appropriately negative, non-

reactive or minimal response in the test system

Note 1 to entry: In practice, negative controls include blanks, vehicles/solvents and reference materials (3.5).

3.5
reference material

material with one or more property values that are sufficiently reproducible and well established

to enable use of the material or substance for the calibration of an apparatus, the assessment of a

measurement method or for the
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.