Dentistry - Casting and baseplate waxes (ISO 15854:2021)

This document specifies the classification of and requirements for dental casting and dental baseplate
waxes together with the test methods to be employed to determine compliance with these requirements.
This document does not apply to waxes supplied for additive manufacturing or CAD/CAM-based
procedures.

Zahnheilkunde - Guss- und Basisplattenwachse (ISO 15854:2021)

Dieses Dokument gilt für Wache, die für den Dentalguss und als dentale Basisplatten verwendet werden. Festgelegt werden die Einteilung von und die Anforderungen an derartige Wachse sowie die anzuwendenden Prüfverfahren, damit die Übereinstimmung mit diesen Anforderungen festgestellt werden kann. Wachse für den 3D-Druck oder für CAD-/CAM-basierte Verfahren liegen außerhalb des Anwendungsbereiches.

Art dentaire - Cires pour coulée et pour plaque de base (ISO 15854:2021)

Zobozdravstvo - Voski za odlitke in podstavke (ISO 15854:2021)

General Information

Status
Published
Public Enquiry End Date
19-Jul-2020
Publication Date
16-Mar-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
22-Feb-2021
Due Date
29-Apr-2021
Completion Date
17-Mar-2021

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SLOVENSKI STANDARD
SIST EN ISO 15854:2021
01-april-2021
Nadomešča:
SIST EN ISO 15854:2005
Zobozdravstvo - Voski za odlitke in podstavke (ISO 15854:2021)
Dentistry - Casting and baseplate waxes (ISO 15854:2021)
Zahnheilkunde - Guss- und Basisplattenwachse (ISO 15854:2021)
Art dentaire - Cires pour coulée et pour plaque de base (ISO 15854:2021)
Ta slovenski standard je istoveten z: EN ISO 15854:2021
ICS:
11.060.10 Zobotehnični materiali Dental materials
SIST EN ISO 15854:2021 en

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

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SIST EN ISO 15854:2021
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SIST EN ISO 15854:2021
EN ISO 15854
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2021
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 15854:2005
English Version
Dentistry - Casting and baseplate waxes (ISO 15854:2021)

Médecine bucco-dentaire - Cires pour coulée et pour Zahnheilkunde - Guss- und Basisplattenwachse (ISO

plaque de base (ISO 15854:2021) 15854:2021)
This European Standard was approved by CEN on 12 December 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15854:2021 E

worldwide for CEN national Members.
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SIST EN ISO 15854:2021
EN ISO 15854:2021 (E)
Contents Page

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

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SIST EN ISO 15854:2021
EN ISO 15854:2021 (E)
European foreword

This document (EN ISO 15854:2021) 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 August 2021, and conflicting national standards shall

be withdrawn at the latest by August 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 15854:2005.

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 15854:2021 has been approved by CEN as EN ISO 15854:2021 without any modification.

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SIST EN ISO 15854:2021
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SIST EN ISO 15854:2021
INTERNATIONAL ISO
STANDARD 15854
Second edition
2021-01
Dentistry — Casting and baseplate
waxes
Médecine bucco-dentaire — Cires pour coulée et pour plaque de base
Reference number
ISO 15854:2021(E)
ISO 2021
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SIST EN ISO 15854:2021
ISO 15854:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 15854:2021
ISO 15854:2021(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 Appearance ................................................................................................................................................................................................ 2

5.2 Flow .................................................................................................................................................................................................................. 2

5.3 Behaviour on trimming ................................................................................................................................................................... 2

5.4 Behaviour on softening (Type 1) ............................................................................................................................................. 2

5.5 Appearance after flaming (Type 2) ....................................................................................................................................... 2

5.6 Behaviour on softening (Type 2) ............................................................................................................................................. 3

5.7 Residue on artificial teeth (Type 2) ......... .............................................................................................................................. 3

5.8 Behaviour of colouring material (Type 2) ....................................................................................................................... 3

5.9 Adhesion on storage (Type 2) .................................................................................................................................................... 3

5.10 Residue on ignition (Type 1)....................................................................................................................................................... 3

5.11 Biocompatibility .................................................................................................................................................................................... 3

6 Sampling ........................................................................................................................................................................................................................ 3

7 Test methods — General............................................................................................................................................................................... 3

7.1 Ambient temperature ........................................................................................................................................................................ 3

7.2 Apparatus function verification ............................................................................................................................................... 4

8 Test methods — Specific ............................................................................................................................................................................... 4

8.1 Visual inspection ................................................................................................................................................................................... 4

8.2 Flow .................................................................................................................................................................................................................. 4

8.2.1 Principle .................................................................................................................................................................................. 4

8.2.2 Apparatus ............................................................................................................................................................................... 4

8.2.3 Preparation of test pieces......................................................................................................................................... 8

8.2.4 Procedure ............................................................................................................................................................................... 9

8.2.5 Expression of results and evaluation ..........................................................................................................10

8.3 Behaviour on trimming ................................................................................................................................................................10

8.3.1 Principle ...............................................................................................................................................................................10

8.3.2 Apparatus ............................................................................................................................................................................10

8.3.3 Procedure ............................................................................................................................................................................10

8.4 Behaviour on softening (Type 1) ..........................................................................................................................................10

8.4.1 Principle ...............................................................................................................................................................................10

8.4.2 Apparatus ............................................................................................................................................................................11

8.4.3 Procedure ............................................................................................................................................................................11

8.5 Appearance after flaming (Type 2) ....................................................................................................................................11

8.5.1 Principle ...............................................................................................................................................................................11

8.5.2 Procedure ............................................................................................................................................................................11

8.6 Behaviour on softening (Type 2) ..........................................................................................................................................11

8.6.1 Principle ...............................................................................................................................................................................11

8.6.2 Apparatus ............................................................................................................................................................................11

8.6.3 Procedure ............................................................................................................................................................................11

8.7 Residue on artificial teeth and behaviour of wax colouring material (Type 2) ...........................12

8.7.1 Principle ...............................................................................................................................................................................12

8.7.2 Apparatus ............................................................................................................................................................................12

8.7.3 Procedure ............................................................................................................................................................................12

8.8 Adhesion on storage (Type 2) .................................................................................................................................................13

8.8.1 Principle ...............................................................................................................................................................................13

© ISO 2021 – All rights reserved iii
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SIST EN ISO 15854:2021
ISO 15854:2021(E)

8.8.2 Apparatus ............................................................................................................................................................................13

8.8.3 Procedure ............................................................................................................................................................................13

8.9 Residue on ignition (Type 1)....................................................................................................................................................14

8.9.1 Principle ...............................................................................................................................................................................14

8.9.2 Apparatus ............................................................................................................................................................................14

8.9.3 Procedure ............................................................................................................................................................................14

9 Marking and packaging ..............................................................................................................................................................................15

9.1 Marking ......................................................................................................................................................................................................15

9.2 Packaging ..................................................................................................................................................................................................15

10 Test report ................................................................................................................................................................................................................15

Annex A (informative) Determination of the melting point of wax ...................................................................................17

Bibliography .............................................................................................................................................................................................................................19

iv © ISO 2021 – All rights reserved
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SIST EN ISO 15854:2021
ISO 15854:2021(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 of 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 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 second edition cancels and replaces the first edition (ISO 15854:2005), which has been technically

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

— the requirement for separating paper for baseplate wax sheets has been revised;

— the statement of the requirement for residue on ignition for casting wax has been revised;

— the mass of wax used for the residue on ignition test has been increased to 10 g;

— the use of a mandrel for the delamination test has been revised;
— clarification has been given on the procedural detail in most tests;
— specification of the content of the required report has 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 2021 – All rights reserved v
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SIST EN ISO 15854:2021
ISO 15854:2021(E)
Introduction

This document does not include specific and quantitative requirements for freedom from biological

hazards. It is recommended that, in assessing possible biological or toxicological hazards, reference be

made to ISO 7405 and ISO 10993-1.
vi © ISO 2021 – All rights reserved
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SIST EN ISO 15854:2021
INTERNATIONAL STANDARD ISO 15854:2021(E)
Dentistry — Casting and baseplate waxes
1 Scope

This document specifies the classification of and requirements for dental casting and dental baseplate

waxes together with the test methods to be employed to determine compliance with these requirements.

This document does not apply to waxes supplied for additive manufacturing or CAD/CAM-based

procedures.
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 6873, Dentistry — Gypsum products

ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules

ISO 8601-2, Date and time — Representations for information interchange — Part 2: Extensions

ISO 22112, Dentistry — Artificial teeth for dental prostheses
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 https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
casting wax

mouldable material with minimal residue on ignition suitable primarily for shaping patterns in the

production of cast restorations using the “lost-wax” technique
3.2
baseplate wax

mouldable material primarily for forming occlusion rims, positioning and retaining artificial teeth

therein, and shaping patterns that are duplicated in the denture base polymer
3.3
melting point
temperature above which no solid material exists at equilibrium

Note 1 to entry: For the practical purposes of this document, the melting point and the freezing point shall be

considered as being the same.
© ISO 2021 – All rights reserved 1
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SIST EN ISO 15854:2021
ISO 15854:2021(E)
4 Classification

Dental waxes covered by this document are classified according to the flow characteristics that

represent their hardness, as follows:
a) Type 1 (casting wax):
1) Class 1 Soft;
2) Class 2 Hard;
b) Type 2 (baseplate wax):
1) Class 1 Soft;
2) Class 2 Hard;
3) Class 3 Extra hard.
5 Requirements
5.1 Appearance

The wax shall be uniform in colour, supplied in pieces of uniform size, of smooth texture and free of

foreign materials. Test in accordance with 8.1.
5.2 Flow

The wax when tested in accordance with 8.2 shall have flow values conforming with the appropriate

requirements in Table 1.
Table 1 — Flow requirements percentages
Type 1 Type 2
Temperature
Class 1 Class 2 Class 1 Class 2 Class 3
min. max. min. max. min. max. min. max. min. max.
23,0 ± 0,2 — — — — — 1,0 — 0,6 — 0,2
30,0 ± 0,2 — 1,0 — — — — — — — —
37,0 ± 0,1 — — — 1,0 5,0 90,0 — 10,0 — 1,2
40,0 ± 0,1 50,0 — — 20,0 — — — — — —
45,0 ± 0,1 70,0 90,0 70,0 90,0 — — 50,0 90,0 5,0 50,0
— not required
5.3 Behaviour on trimming

The wax shall be capable of being trimmed without chipping, flaking, or other undesirable behaviour

when tested in accordance with 8.3.
5.4 Behaviour on softening (Type 1)

The wax shall soften without flaking or crumbling and shall cohere readily when tested in accordance

with 8.4.
5.5 Appearance after flaming (Type 2)

The wax shall present a smooth glossy surface when tested in accordance with 8.5.

2 © ISO 2021 – All rights reserved
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SIST EN ISO 15854:2021
ISO 15854:2021(E)
5.6 Behaviour on softening (Type 2)

The wax shall soften without becoming sticky or crumbly and shall be mouldable without breaking or

delaminating when tested in accordance with 8.6.

This requirement shall not apply to baseplate preforms where a suitable square test piece cannot be cut.

5.7 Residue on artificial teeth (Type 2)

The wax shall not leave a visible residue on either ceramic or synthetic polymer teeth when tested in

accordance with 8.7.
5.8 Behaviour of colouring material (Type 2)

The colouring material shall neither separate from the wax nor impregnate the gypsum mould when

tested in accordance with 8.7.
5.9 Adhesion on storage (Type 2)

Adhesion due to storage of the wax shall be such that, when tested in accordance with 8.8, there shall

be no evidence of damage to wax surfaces. Wax and separating paper surfaces shall separate cleanly

and readily.
NOTE The separating paper might not cover the whole area of the wax sheet.
5.10 Residue on ignition (Type 1)

If the manufacturer does not state a value for the residue on ignition, the value as determined in

accordance with 8.9 shall be no greater than 0,10 % by mass.

If the residue on ignition is greater than 0,10 % by mass, this value shall be stated by the manufacturer

and the value as determined in accordance with 8.9 shall be not more than 20 % greater than that

stated value.
5.11 Biocompatibility

See ISO 7405 and ISO 10993-1 for guidance on compatibility in respect of waxes that are offered for use

in the mouth or that are not specifically excluded from that application.
6 Sampling

The amount of material procured for testing shall be at least 250 g for Type 1, or 500 g for Type 2, and

from one batch, and one packet where possible. This material shall be obtained on the open market

unannounced and thus taken randomly from stock.
7 Test methods — General
7.1 Ambient temperature

Unless otherwise specified in this document, all test piece preparation and testing shall be conducted at

an ambient temperature of (23 ± 2) °C. Where necessary and appropriate, all material shall be allowed

to equilibrate at this ambient temperature before testing for at least 24 h.
© ISO 2021 – All rights reserved 3
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SIST EN ISO 15854:2021
ISO 15854:2021(E)
7.2 Apparatus function verification

All accessories, instruments and equipment shall be examined before use to ensure that they are in

acceptable working order, appropriately calibrated, and complying with specifications stated for them

in this document, as appropriate.
8 Test methods — Specific
8.1 Visual inspection

Carry out the inspection at an illuminance of at least 1000 lux and at a distance not exceeding 250 mm.

A person making the inspection shall have nominally normal visual acuity. Corrective (non-magnifying)

untinted lenses may be worn.
8.2 Flow
8.2.1 Principle

The relative change in length of the test piece under a given load in a specified time is taken as a proxy

for the inverse of viscosity.
8.2.2 Apparatus
8.2.2.1 Micrometer screw gauge

Micrometer screw gauge with a range of at least 10 mm, being readable and accurate to 0,005 mm or

better, equipped with flat, parallel anvils at least 6,5 mm in diameter and a non-rotating spindle.

NOTE Avoidance of indentation of the wax test piece is essential.
8.2.2.2 Flow-testing instrument

A flow-testing instrument, such as the one shown in Figure 1, consisting of the following components:

— weight (see Figure 1, Key 1);

— shaft, which can move freely in its supports, lubricated as necessary (see Figure 1, Key 2);

— upper platen, metallic, minimum diameter 50 mm, lower surface flat and smooth, rigidly attached

and normal to the axis of the shaft (see Figure 1, Key 3);

— base plate, metallic, flat smooth and parallel to the lower surface of the upper platen (Figure 1, Key 4);

— measuring dial gauge or similarly functional instrument, with a range of at least 10 mm, readable

and accurate to 0,005 mm or better, and rigidly supported (optional) (see Figure 1, Key 5);

— locking screw or equivalent device (required if the dial gauge is used) (see Figure 1, Key 6).

4 © ISO 2021 – All rights reserved
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SIST EN ISO 15854:2021
ISO 15854:2021(E)
Key
1 weight
2 shaft
3 upper platen
4 base plate
5 dial gauge (optional)
6 locking screw
NOTE This figure is not to scale.
Figure 1 — Conceptual diagram of a suitable flow-testing instrument
The total mass of the components of items 1, 2 and
...

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