Dentistry - Polymer-based crown and veneering materials (ISO 10477:2020)

This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.

Zahnheilkunde - Polymerbasierte Kronen- und Verblendwerkstoffe (ISO 10477:2020)

Dieses Dokument beschreibt die Einteilung von polymerbasierten Kronen und Verblendwerkstoffen, die in der Zahnheilkunde verwendet werden, und legt ihre Anforderungen fest. Ebenso beschreibt es die Prüfverfahren, die zur Beurteilung der Konformität mit diesen Anforderungen verwendet werden.
Dieses Dokument gilt für polymerbasierte Kronen und Verblendwerkstoffe für im Labor hergestellte dauerhafte Verblendschalen oder Kronen. Es gilt ebenfalls für polymerbasierte dentale Kronen und Verblendwerkstoffe, für die der Hersteller angibt, dass sie an der Gerüststruktur ohne makro mechanische Retentionen, wie Perlen oder Drähte, haften.

Médecine bucco-dentaire - Produits à base de polymères pour couronnes et facettes (ISO 10477:2020)

Le présent document établit une classification des produits à base de polymères pour couronnes et facettes utilisés en médecine bucco‑dentaire, et spécifie les exigences qui leur sont applicables. Il spécifie également les méthodes d'essai à utiliser en vue de la détermination de leur conformité à ces exigences.
Le présent document est applicable aux produits à base de polymères pour couronnes et facettes destinés aux couronnes ou facettes permanentes fabriquées en laboratoire. Il s'applique également aux produits à base de polymères pour couronnes et facettes pour lesquels le fabricant revendique une adhérence à l'infrastructure sans rétention macromécanique, telle que les billes ou les fils.

Zobozdravstvo - Polimerni materiali za prevleke in mostičke (ISO 10477:2020)

General Information

Status

Published

Publication Date

03-Nov-2020

Withdrawal Date

30-May-2021

ICS

11.060.10 - Dental materials

Technical Committee

CEN/TC 55 - Dentistry

Drafting Committee

CEN/TC 55 - Dentistry

Current Stage

6060 - Definitive text made available (DAV) - Publishing

Start Date

04-Nov-2020

Completion Date

04-Nov-2020

Ref Project

SIST EN ISO 10477:2020 - Dentistry - Polymer-based crown and veneering materials (ISO 10477:2020)

Relations

Replaces

EN ISO 10477:2018 - Dentistry - Polymer-based crown and veneering materials (ISO 10477:2018)

Effective Date

23-Oct-2019

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SLOVENSKI STANDARD
SIST EN ISO 10477:2020
01-december-2020
Nadomešča:
SIST EN ISO 10477:2018
Zobozdravstvo - Polimerni materiali za prevleke in mostičke (ISO 10477:2020)
Dentistry - Polymer-based crown and veneering materials (ISO 10477:2020)
Zahnheilkunde - Polymerbasierte Kronen- und Verblendwerkstoffe (ISO 10477:2020)

Médecine bucco-dentaire - Produits à base de polymères pour couronnes et facettes

(ISO 10477:2020)
Ta slovenski standard je istoveten z: EN ISO 10477:2020
ICS:
11.060.10 Zobotehnični materiali Dental materials
SIST EN ISO 10477:2020 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 10477:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 10477:2020
EN ISO 10477
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2020
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 10477:2018
English Version
Dentistry - Polymer-based crown and veneering materials
(ISO 10477:2020)

Médecine bucco-dentaire - Produits à base de Zahnheilkunde - Polymerbasierte Kronen- und

polymères pour couronnes et facettes (ISO Verblendwerkstoffe (ISO 10477:2020)
10477:2020)
This European Standard was approved by CEN on 12 September 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

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 10477:2020
EN ISO 10477:2020 (E)
Contents Page

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

---------------------- Page: 4 ----------------------
SIST EN ISO 10477:2020
EN ISO 10477:2020 (E)
European foreword

This document (EN ISO 10477:2020) 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 2021, and conflicting national standards shall be

withdrawn at the latest by May 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 supersedes EN ISO 10477:2018.

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 10477:2020 has been approved by CEN as EN ISO 10477:2020 without any modification.

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SIST EN ISO 10477:2020
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SIST EN ISO 10477:2020
INTERNATIONAL ISO
STANDARD 10477
Fourth edition
2020-10
Dentistry — Polymer-based crown and
veneering materials
Médecine bucco-dentaire — Produits à base de polymères pour
couronnes et facettes
Reference number
ISO 10477:2020(E)
ISO 2020
---------------------- Page: 7 ----------------------
SIST EN ISO 10477:2020
ISO 10477:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 10477:2020
ISO 10477:2020(E)
Contents Page

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

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

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

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

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

4 Classification ............................................................................................................................................................................................................ 2

5 Requirements .......................................................................................................................................................................................................... 2

5.1 General ........................................................................................................................................................................................................... 2

5.2 Depth of cure ............................................................................................................................................................................................ 3

5.2.1 General...................................................................................................................................................................................... 3

5.2.2 Depth of cure, type 2, class 2 materials ........................................................................................................ 3

5.3 Surface finish ............................................................................................................................................................................................ 3

5.4 Flexural strength ................................................................................................................................................................................... 3

5.5 Bond strength........................................................................................................................................................................................... 4

5.5.1 Special bonding system without macromechanical retention ................................................. 4

5.5.2 Values higher than 5 MPa ......................................................................................................................................... 4

5.6 Water sorption ........................................................................................................................................................................................ 4

5.7 Solubility ...................................................................................................................................................................................................... 4

5.8 Shade consistency ................................................................................................................................................................................ 4

5.9 Colour stability ........................................................................................................................................................................................ 4

5.10 Biocompatibility .................................................................................................................................................................................... 4

6 Sampling ........................................................................................................................................................................................................................ 4

6.1 For all tests ................................................................................................................................................................................................. 4

6.2 For test of shade consistency ...................................................................................................................................................... 5

6.3 For test of colour stability ............................................................................................................................................................. 5

7 Measurement and test methods ........................................................................................................................................................... 5

7.1 General ........................................................................................................................................................................................................... 5

7.1.1 Test conditions................................................................................................................................................................... 5

7.1.2 Water .......................................................................................................................................................................................... 5

7.1.3 Preparation of test specimens .............................................................................................................................. 5

7.2 Visual inspection ................................................................................................................................................................................... 5

7.3 Depth of cure ............................................................................................................................................................................................ 5

7.3.1 Apparatus ............................................................................................................................................................................... 5

7.3.2 Materials ................................................................................................................................................................................. 6

7.3.3 Procedure ............................................................................................................................................................................... 6

7.3.4 Expression of results .................................................................................................................................................... 6

7.4 Surface finish ............................................................................................................................................................................................ 6

7.5 Flexural strength ................................................................................................................................................................................... 7

7.5.1 Apparatus ............................................................................................................................................................................... 7

7.5.2 Materials ................................................................................................................................................................................. 8

7.5.3 Preparation of test specimens .............................................................................................................................. 8

7.5.4 Procedure ............................................................................................................................................................................... 9

7.5.5 Expression of results .................................................................................................................................................... 9

7.6 Bond strength........................................................................................................................................................................................10

7.6.1 Apparatus ............................................................................................................................................................................10

7.6.2 Materials ..............................................................................................................................................................................11

7.6.3 Preparation of test specimens ...........................................................................................................................11

7.6.4 Procedure ............................................................................................................................................................................12

7.6.5 Expression of results .................................................................................................................................................13

7.7 Water sorption and solubility .................................................................................................................................................13

7.7.1 Apparatus ............................................................................................................................................................................13

7.7.2 Materials ..............................................................................................................................................................................14

© ISO 2020 – All rights reserved iii
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SIST EN ISO 10477:2020
ISO 10477:2020(E)

7.7.3 Preparation of test specimen .............................................................................................................................14

7.7.4 Procedure ............................................................................................................................................................................14

7.7.5 Expression of results .................................................................................................................................................15

7.8 Shade consistency and colour stability ...........................................................................................................................16

7.8.1 General...................................................................................................................................................................................16

7.8.2 Apparatus ............................................................................................................................................................................16

7.8.3 Materials ..............................................................................................................................................................................16

7.8.4 Preparation of test specimens ...........................................................................................................................17

7.8.5 Procedure ............................................................................................................................................................................17

7.8.6 Colour comparison ......................................................................................................................................................17

7.8.7 Expression of results for shade consistency .........................................................................................17

7.8.8 Expression of results for colour stability .................................................................................................18

8 Packaging and labelling .............................................................................................................................................................................18

8.1 Packaging ..................................................................................................................................................................................................18

8.2 Labelling ....................................................................................................................................................................................................18

8.2.1 General...................................................................................................................................................................................18

8.2.2 Labelling of outer pack ............................................................................................................................................18

8.2.3 Labelling of containers ............................................................................................................................................18

9 Instructions for use ........................................................................................................................................................................................19

Bibliography .............................................................................................................................................................................................................................21

iv © ISO 2020 – All rights reserved
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SIST EN ISO 10477:2020
ISO 10477:2020(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, Subcommittee SC 2,

Prosthodontic materials, in collaboration with the European Committee for Standardization (CEN)

Technical Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation

between ISO and CEN (Vienna Agreement).

This fourth edition cancels and replaces the third edition (ISO 10477:2018), which has been technically

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

— missing exemption condition for opaque resin test specimens in line 6 of Table 1 has been added;

— required number of specimen in 7.8 (Shade consistency and colour stability) has been corrected;

— several editorial changes have been made to describe the procedures more precisely;

— appropriate intervals for the storage times described in the procedures have been added.

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.
© ISO 2020 – All rights reserved v
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SIST EN ISO 10477:2020
ISO 10477:2020(E)
Introduction

Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable

biological hazards are not included in this document, but it is recommended that, for the assessment of

possible biological hazards, reference should be made to ISO 10993-1 and ISO 7405.

vi © ISO 2020 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 10477:2020
INTERNATIONAL STANDARD ISO 10477:2020(E)
Dentistry — Polymer-based crown and veneering
materials
1 Scope

This document classifies polymer-based crown and veneering materials used in dentistry and specifies

their requirements. It also specifies the test methods to be used to determine conformity to these

requirements.

This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated

permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials

for which the manufacturer claims adhesion to the substructure without macro-mechanical retention

such as beads or wires.
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 3696, Water for analytical laboratory use — Specification and test methods

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

ISO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 7491, Dental materials — Determination of colour stability

ISO 8601 (all parts), Data elements and interchange formats — Information interchange — Representation

of dates and times

ISO 22674, Dentistry — Metallic materials for fixed and removable restorations and appliances

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.

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

— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
polymer-based crown and veneering material

composition of powders and liquids or pastes that may contain monomers, inorganic and/or polymeric

fillers and that, when polymerized, is suitable for use as permanent dental veneers or crowns

Note 1 to entry: Polymerization is effected by mixing initiator(s) and activator(s) (“self-curing” materials) and/

or by external energy activation [by heat (“heat-curing” materials), photoactivated materials, by visible light

(“light-curing” materials) and/or by UV radiation].

Note 2 to entry: The polymer-based crown and veneering materials for laboratory-fabricated permanent veneers

or crowns may or may not be attached to a substructure.
© ISO 2020 – All rights reserved 1
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SIST EN ISO 10477:2020
ISO 10477:2020(E)
3.2
dentine resin

pigmented and slightly translucent polymer-based crown and veneering material (3.1) that simulates the

natural appearance of dentine
3.3
enamel resin

translucent and slightly pigmented polymer-based crown and veneering material (3.1) that is packed in a

layer over the dentine resin and that simulates the natural appearance of enamel
3.4
cervical resin

intensely pigmented and slightly translucent polymer-based crown and veneering material (3.1) that

simulates the natural appearance of dentine of the cervical region of the tooth
3.5
opaque resin

intensely pigmented polymer-based crown and veneering material (3.1) applied in thin layers with the

purposes of completely masking the underlying material and bonding to it

Note 1 to entry: Opaque resins are only required to fulfil the requirement of 5.5.

4 Classification

The polymer-based crown and veneering materials described in this document shall be classified

according to their activation system for polymerization.

— Type 1: polymer-based crown and veneering materials whose setting is effected by mixing

initiator(s) and activator(s) (“self-curing” materials);

— Type 2: polymer-based crown and veneering materials whose setting is effected by the application

of energy from an external source (“external-energy-activated” materials), such as heat and/or

radiation (visible or UV range);

— Class 1: polymer-based crown and veneering materials that do not contain a photo-

polymerization initiator;

— Class 2: polymer-based crown and veneering materials that contain a photo-polymerization

initiator;

— Type 3: polymer-based crown and veneering materials whose setting is effected by mixing

initiator(s) and activator(s) and also by the application of energy from an external source (“dual-

cure” materials).
5 Requirements
5.1 General

The tests required for a crown and veneering material depend on the classification according to type

and class.
See Table 1 for the necessity of the specific tests described in 5.2 to 5.9.
2 © ISO 2020 – All rights reserved
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SIST EN ISO 10477:2020
ISO 10477:2020(E)
Table 1 — Test protocol
Subclause Property Type 1 Type 2 Type 3
Class 1 Class 2
5.2 Depth of cure — — + —
a a a a
5.3 Surface finish + + + +
a a a a
5.4 Flexural strength + + + +
5.5 Bond strength + + + +
a a a a
5.6 to 5.9 Water sorption, solubility, + + + +
shade consistency, colour
stability
+ carry out test;
— do not test.
If the material is opaque resin, do not test.
5.2 Depth of cure
5.2.1 General
Testing shall be carried out in accordance with 7.3.
5.2.2 Depth of cure, type 2, class 2 materials

For type 2, class 2 polymer-based crown and veneering materials, the hardness of the bottom surface

shall be not less than 70 % of that of the top surface (see Table 2).

For type 1, type 2, class 1 and type 3 materials, no requirement is specified. This requirement is not

applicable to opaque resins.
5.3 Surface finish
A test specimen polished in accordance with 7.4 shall have a glossy surface.

Testing shall be carried out in accordance with 7.4. This requirement is not applicable to opaque resins.

5.4 Flexural strength

The flexural strength shall be at least 50 MPa (see Table 2). This requirement is not applicable to

SLOVENSKI STANDARD
oSIST prEN ISO 10477:2020
01-marec-2020
Zobozdravstvo - Polimerni materiali za prevleke in mostičke (ISO/DIS 10477:2020)
Dentistry - Polymer-based crown and veneering materials (ISO/DIS 10477:2020)
Zahnheilkunde - Polymerbasierte Kronen- und Verblendwerkstoffe (ISO/DIS
10477:2020)

Médecine bucco-dentaire - Produits à base de polymères pour couronnes et facettes

(ISO/DIS 10477:2020)
Ta slovenski standard je istoveten z: prEN ISO 10477
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 10477:2020 en

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

---------------------- Page: 1 ----------------------
oSIST prEN ISO 10477:2020
---------------------- Page: 2 ----------------------
oSIST prEN ISO 10477:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10477
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-01-28 2020-04-21
Dentistry — Polymer-based crown and veneering
materials

Médecine bucco-dentaire — Produits à base de polymères pour couronnes et facettes

ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10477:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 10477:2020
ISO/DIS 10477:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 10477:2020
ISO/DIS 10477:2020(E)
Contents Page

5.2.1 General...................................................................................................................................................................................... 3

5.2.2 Depth of cure, Type 2, Class 2 materials ...................................................................................................... 3