Dentistry — Casting and baseplate waxes

This document specifies the classification of and requirements for waxes used for dental casting (including products intended for CAD/CAM milling) using the lost-wax technique and dental baseplate preparation together with the test methods to be employed to determine compliance with these requirements. Solid polymer products (such as acrylics) for CAD/CAM work, and thermoplastic or photo-curing resins used in additive processes, are not covered by this document. This document does not include specific and quantitative requirements for freedom from biological hazards.

Médecine bucco-dentaire — Cires pour coulée et pour plaque de base

Le présent document spécifie la classification et les exigences relatives aux cires utilisées pour la coulée dentaire (y compris les produits destinés au fraisage CFAO) à l’aide de la technique dite « cire perdue » et la préparation des plaques de base dentaires ainsi que les méthodes d’essai à appliquer pour déterminer la conformité à ces exigences. Les produits à base de polymères solides (tels que les acryliques) pour les travaux de CFAO, ainsi que les résines thermoplastiques ou photodurcissables utilisées dans les processus additifs, ne sont pas couverts par le présent document. Le présent document ne spécifie pas les exigences quantitatives spécifiques à l’élimination des risques biologiques.

General Information

Status
Not Published
Current Stage
6000 - International Standard under publication
Completion Date
15-Nov-2022
Ref Project

Relations

Buy Standard

Draft
REDLINE ISO/PRF 15854 - Dentistry — Casting and baseplate waxes Released:18. 10. 2022
English language
20 pages
sale 15% off
Preview
sale 15% off
Preview
Draft
ISO/PRF 15854 - Dentistry — Casting and baseplate waxes Released:18. 10. 2022
English language
20 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

ISO/DIS 15854:2022(E)
ISO/TC 106 SC 2
Third edition
Dentistry — Casting and baseplate waxes
Médecine bucco-dentaire — Cires pour coulée et pour plaque de base
Third edition
Date: 2022-05-0810-18
---------------------- Page: 1 ----------------------
ISO 15854:2022(E)
© ISO 2022

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-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland.
ii © ISO 2022 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 15854:2022(E)
Contents Page

Foreword ................................................................................................................................................... 5

Introduction ............................................................................................................................................. 6

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 ......................................................................................................... 3

5.4 Behaviour on softening — Type 1 ...................................................................................... 3

5.5 Appearance after flaming ..................................................................................................... 3

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 ...................................................................................................................... 4

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

7 Test methods — General ....................................................................................................... 4

7.1 Ambient temperature ............................................................................................................ 4

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 ..................................................................................................... 9

8.2.4 Procedure ................................................................................................................................. 11

8.2.5 Expression of results and evaluation ............................................................................. 12

8.3 Behaviour on trimming ....................................................................................................... 12

8.3.1 Principle .................................................................................................................................... 12

8.3.2 Apparatus ................................................................................................................................. 12

8.3.3 Procedure ................................................................................................................................. 12

8.4 Behaviour on softening — Type 1 .................................................................................... 13

8.4.1 Principle .................................................................................................................................... 13

8.4.2 Apparatus ................................................................................................................................. 13

8.4.3 Procedure ................................................................................................................................. 13

8.5 Appearance after flaming ................................................................................................... 13

8.5.1 Principle .................................................................................................................................... 13

8.5.2 Procedure ................................................................................................................................. 13

8.6 Behaviour on softening — Type 2 .................................................................................... 14

8.6.1 Principle .................................................................................................................................... 14

8.6.2 Apparatus ................................................................................................................................. 14

8.6.3 Procedure ................................................................................................................................. 14

8.7 Residue on artificial teeth and behaviour of wax colouring material — Type 2

...................................................................................................................................................... 14

© ISO 2022 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 15854:2022(E)

8.7.1 Principle ....................................................................................................................................14

8.7.2 Apparatus .................................................................................................................................14

8.7.3 Procedure .................................................................................................................................14

8.8 Adhesion on storage — Type 2 .........................................................................................16

8.8.1 Principle ....................................................................................................................................16

8.8.2 Apparatus .................................................................................................................................16

8.8.3 Procedure .................................................................................................................................16

8.9 Residue on ignition — Type 1 ...........................................................................................17

8.9.1 Principle ....................................................................................................................................17

8.9.2 Apparatus .................................................................................................................................17

8.9.3 Procedure .................................................................................................................................17

9 Marking and packaging .......................................................................................................18

9.1 Marking .....................................................................................................................................18

9.2 Packaging ..................................................................................................................................18

10 Test report ...............................................................................................................................18

Annex A (informative) Determination of the melting point of wax ....................................20

A.1 General ......................................................................................................................................20

A.2 Equipment ................................................................................................................................20

A.2.1 Thermometer ..........................................................................................................................20

A.2.2 Data logger ...............................................................................................................................20

A.2.3 Test tube ...................................................................................................................................20

A.2.4 Copper wire .............................................................................................................................20

A.2.5 Draft shield ..............................................................................................................................20

A.3 Method .......................................................................................................................................20

Bibliography ..........................................................................................................................................22

iv © ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 15854:2022(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 third edition cancels and replaces the second edition (ISO 15854:2021), which has been

technically revised.
The main changes compared with the previous edition are as follows:
— the scope has been clarified;
— waxes supplied for use in CAD/CAM procedures have been included;
— the appearance after flaming has been extended to include casting waxes.

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 2022 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO 15854:2022(E)
Introduction

For the purposes of this document, the term ‘casting’ includes ‘pressing’, as used for glass

ceramics.

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

made to ISO 7405 and ISO 10993-1.
vi © ISO 2022 – All rights reserved
---------------------- Page: 6 ----------------------
INTERNATIONAL STANDARD ISO 15854:2022(E)
Dentistry — Casting and baseplate waxes
1 Scope

This document specifies the classification of and requirements for waxes used for dental casting

(including products intended for CAD/CAM milling) using the lost-wax technique and dental

baseplate preparation together with the test methods to be employed to determine compliance

with these requirements.

Solid polymer products (such as acrylics) for CAD/CAM work, and thermoplastic or photo-curing

resins used in additive processes, are not covered by this document.

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

biological hazards.
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 428721920-2, Geometrical product specifications (GPS) -— Surface texture: Profile method -—

Part 2: Terms, definitions and surface texture parameters
ISO 6873, Dentistry — Gypsum products

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

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 terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://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 (3.5)
3.2
baseplate wax
© ISO 2022 – All rights reserved 1
---------------------- Page: 7 ----------------------
ISO 15854:2022(E)

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
milling wax
casting wax (3.1) where patterns are formed by milling using CAD/CAM systems
3.4
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.
3.5
lost-wax technique

method of casting using a wax pattern that is removed from the intact investment mould by

melting or burning
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, for lost-wax technique):
1) Class 1: Soft;
2) Class 2: Hard;
3) Class 3: Milling.
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 3 Class 1 Class 2 Class 3
2 © ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
ISO 15854:2022(E)
min. max. min. max. 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 1,0 5,0 90,0 — 10,0 — 1,2
40,0 ± 0,1 50,0 — — 20,0 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

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

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 can possibly 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.
© ISO 2022 – All rights reserved 3
---------------------- Page: 9 ----------------------
ISO 15854:2022(E)
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

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.
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 1 000 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.

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

Flow-testing instrument, such as 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);

4 © ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
ISO 15854:2022(E)

— 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 (see

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).

© ISO 2022 – All rights reserved 5
---------------------- Page: 11 ----------------------
ISO 15854:2022(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 3 shall be such as to provide an axial

compressive force of (19,6 ± 0,1) N. The weight (Figure 1, Key 1) shall be separated from the

surface of the water in the bath by at least 20 mm. The upper platen (Figure 1, Key 3) shall be at

least 5 mm thick for rigidity. The optional dial gauge (Figure 1, Key 5) and locking screw (Figure 1,

Key 6) can replace the micrometer screw gauge for direct measurement of displacement (see

8.2.3).

The axial force calculation shall take into account the buoyancy of the immersed parts of the shaft

and upper platen (using the value of 0,01 N/ml) and the force exerted by the dial gauge or other

measuring device (Figure 1, Key 5), which force may be about 1 N and vary with its displacement

if (as is usual) a spring is present. Appropriate control of the water level in the water bath (8.2.2.9)

is required.

The locking screw or equivalent device shall not cause damage to the shaft (Figure 1, Key 2) and

thereby impede its free movement.

The base plate (Figure 1, Key 4) can conveniently be marked with a crosshair target, , avoiding

affecting the surface of the central region, to enable the correct location of the test piece.

6 © ISO 2022 – All rights reserved
---------------------- Page: 12 ----------------------
ISO 15854:2022(E)
8.2.2.3 Pouring pan

For melting the wax, use a metal, glass or ceramic vessel, which may have a handle for

convenience, similar in functionality to the example shown in Figure 2.
NOTE A volume of 10 ml to 20 ml can be adequate.
Figure 2 — Example of a suitable pouring pan
8.2.2.4 Heat source

For melting the wax, any convenient low-power or low-temperature system can be used. For

example,

— an infrared lamp with nominal power of (250 ± 50) W using a bulb of type R40 or similar;

— a hotplate giving good thermal contact with the base of the pouring pan (8.2.2.3);

— a hot-air oven allowing the wax to be observed.

For preheating, the mould (8.2.2.6), slab (8.2.2.7) and), glass plate (8.2.2.8) and an oven shall be

used.
8.2.2.5 Thermometer

To measure the temperature of the molten wax, use an electronic thermometer with an accuracy

of ±0,2 °C and a reading resolution of ±0,1 K or better over the temperature range 20 °C to 100 °C,

and having a 95 % 10 K step change response time of less than 1 min.
© ISO 2022 – All rights reserved 7
---------------------- Page: 13 ----------------------
ISO 15854:2022(E)
8.2.2.6 Mould

For forming the flow test pieces, a metallic mould shall be used, for example made from stainless

steel or brass. This shall consist of a flat plate, (6,00 ± 0,01) mm thick, with parallel top and bottom

surfaces. The plate shall have one or more holes (10,00 ± 0,01) mm in diameter, with the axis of

each hole perpendicular to the surface of the plate. The upper and lower faces of the plate shall be

finished to roughness R ≤ 6,3 µm, and the hole wall shall be finished to roughness R ≤ 0,3 µm,

a a
according to ISO 4287.

NOTE It can be convenient to use a multiple mould such that several test pieces can be prepared at a

time, for example as shown in Figure 3.
Dimensions in millimetres
Figure 3 — Example of a suitable mould for preparing flow test pieces
8.2.2.7 Glass slab

As a base for the mould, use a flat, polished glass slab, large enough for the purpose (i.e. larger

than the extent of the mould plate).
8 © ISO 2022 – All rights reserved
---------------------- Page: 14 ----------------------
ISO 15854:2022(E)

NOTE A dental mixing slab, approximately 150 mm long, 75 mm wide and 19 mm thick, is convenient.

8.2.2.8 Glass plate

For covering the mould (8.2.2.6), use a flat, polished glass plate, large enough for the purpose and

covered with thin, flat aluminium foil. The assembly shall be weighed.
8.2.2.9 Water bath

Use a rigid, stable water bath of sufficiently large volume, equipped with a temperature control

device and a stirring device that together ensure sufficient accuracy, stability and homogeneity of

temperature, according to the tolerances shown in Table 1, over the test volume.
8.2.2.10 Anti-vibration table

If vibration is discernible, or there is an appreciable risk of flow results being affected by vibration,

then an anti-vibration table, for example of the kind used to carry and isolate analytical balances,

shall be used to carry the water bath (8.2.2.9).

NOTE Vibration, such as from traffic and footfall, and in particular the vertical component thereof

(‘hammering’), can cause flow values to be significantly increased, whether or not ordinarily apparent.

The water bath stirring device can, if attached to the water bath itself, be a source of significant

vibration; it is preferable to suspend this component separately to avoid that vibration.

8.2.2.11 Silicone grease

Food-grade poly(dimethylsiloxane)-based, petroleum product-free grease of service temperature

range at least −50 °C to 150 °C, of low to medium viscosity.
8.2.2.12 Polyethylene film

Flat, smooth, crease and wrinkle-free, in approximately square sheets no less than 50 mm on a

side.
8.2.2.13 Timing devices

Clocks or timers to permit intervals from 60 s to 25 h to be noted, accurate and reading to 1 s.

8.2.2.14 Deadweight

For loading the glass plate (8.2.2.8), according to the number of test pieces involved, such that the

total load per test piece is (23 ± 1) N.
8.2.2.15 CAD/CAM machine

For Type 1 Class 3, any milling machine capable of producing the test pieces can be used. The

machine setup, production and post-processing steps and conditions shall follow the

requirements of the ‘Instructions for Use’ documentation of both the machine and the material

manufacturers.
8.2.3 Preparation of test pieces
8.2.3.1 Type 1 Classes 1 and 2, Type 2

Lubricate the mould (8.2.2.6) internally with a very thin film of silicone grease as release agent

and place it on a smooth glass slab (8.2.2.7). Preheat both to a temperature (10 ± 5) K above the

melting point of the wax, which temperature shall be maintained until the liquid wax is ready to

be poured.

NOTE 1 The melting point of the wax, if not known from the manufacturer’s or supplier’s information, can

be determined by a procedure such as that indicated in Annex A.
© ISO 2022 – All rights reserved 9
--------------
...

INTERNATIONAL ISO
STANDARD 15854
Third edition
Dentistry — Casting and baseplate
waxes
Médecine bucco-dentaire — Cires pour coulée et pour plaque de base
PROOF/ÉPREUVE
Reference number
ISO 15854:2022(E)
© ISO 2022
---------------------- Page: 1 ----------------------
ISO 15854:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

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
PROOF/ÉPREUVE © ISO 2022 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 15854:2022(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 .................................................................................................................................................................. 3

5.4 Behaviour on softening — Type 1 ......................................................................................................................................... 3

5.5 Appearance after flaming ............................................................................................................................................................. 3

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 ....................................................................................................................................................................................................................... 4

7 Test methods — General .............................................................................................................................................................................. 4

7.1 Ambient temperature ....................................................................................................................................................................... 4

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 ............................................................................................................................................................... 11

8.3.1 Principle .................................................................................................................................................................................. 11

8.3.2 Apparatus .............................................................................................................................................................................. 11

8.3.3 Procedure .............................................................................................................................................................................. 11

8.4 Behaviour on softening — Type 1 ...................................................................................................................................... 11

8.4.1 Principle .................................................................................................................................................................................. 11

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

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

8.5 Appearance after flaming .......................................................................................................................................................... 12

8.5.1 Principle .................................................................................................................................................................................. 12

8.5.2 Procedure .............................................................................................................................................................................. 12

8.6 Behaviour on softening — Type 2 ......................................................................................................................................12

8.6.1 Principle .................................................................................................................................................................................. 12

8.6.2 Apparatus .............................................................................................................................................................................. 12

8.6.3 Procedure ..............................................................................................................................................................................12

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

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

8.7.2 Apparatus .............................................................................................................................................................................. 13

8.7.3 Procedure ..............................................................................................................................................................................13

8.8 Adhesion on storage — Type 2 .............................................................................................................................................. 14

8.8.1 Principle .................................................................................................................................................................................. 14

iii
© ISO 2022 – All rights reserved PROOF/ÉPREUVE
---------------------- Page: 3 ----------------------
ISO 15854:2022(E)

8.8.2 Apparatus .............................................................................................................................................................................. 14

8.8.3 Procedure .............................................................................................................................................................................. 14

8.9 Residue on ignition — Type 1 ................................................................................................................................................ 15

8.9.1 Principle .................................................................................................................................................................................. 15

8.9.2 Apparatus .............................................................................................................................................................................. 15

8.9.3 Procedure .............................................................................................................................................................................. 15

9 Marking and packaging .............................................................................................................................................................................16

9.1 Marking ...................................................................................................................................................................................................... 16

9.2 Packaging ................................................................................................................................................................................................. 16

10 Test report ...............................................................................................................................................................................................................16

Annex A (informative) Determination of the melting point of wax .................................................................................18

Bibliography .............................................................................................................................................................................................................................20

PROOF/ÉPREUVE © ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 15854:2022(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 third edition cancels and replaces the second edition (ISO 15854:2021), which has been technically

revised.
The main changes compared with the previous edition are as follows:
— the scope has been clarified;
— waxes supplied for use in CAD/CAM procedures have been included;
— the appearance after flaming has been extended to include casting waxes.

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 2022 – All rights reserved PROOF/ÉPREUVE
---------------------- Page: 5 ----------------------
ISO 15854:2022(E)
Introduction

For the purposes of this document, the term ‘casting’ includes ‘pressing’, as used for glass ceramics.

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

ISO 7405 and ISO 10993-1.
PROOF/ÉPREUVE © ISO 2022 – All rights reserved
---------------------- Page: 6 ----------------------
INTERNATIONAL STANDARD ISO 15854:2022(E)
Dentistry — Casting and baseplate waxes
1 Scope

This document specifies the classification of and requirements for waxes used for dental casting

(including products intended for CAD/CAM milling) using the lost-wax technique and dental baseplate

preparation together with the test methods to be employed to determine compliance with these

requirements.

Solid polymer products (such as acrylics) for CAD/CAM work, and thermoplastic or photo-curing resins

used in additive processes, are not covered by this document.

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

hazards.
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 21920-2, Geometrical product specifications (GPS) — Surface texture: Profile — Part 2: Terms,

definitions and surface texture parameters
ISO 6873, Dentistry — Gypsum products

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

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 terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// 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 (3.5)
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
milling wax
casting wax (3.1) where patterns are formed by milling using CAD/CAM systems
© ISO 2022 – All rights reserved PROOF/ÉPREUVE
---------------------- Page: 7 ----------------------
ISO 15854:2022(E)
3.4
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.
3.5
lost-wax technique

method of casting using a wax pattern that is removed from the intact investment mould by melting or

burning
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, for lost-wax technique):
1) Class 1: Soft;
2) Class 2: Hard;
3) Class 3: Milling.
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 3 Class 1 Class 2 Class 3
min. max. min. max. 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 1,0 5,0 90,0 — 10,0 — 1,2
40,0 ± 0,1 50,0 — — 20,0 20,0 — — — — — —
45,0 ± 0,1 70,0 90,0 70,0 90,0 — — — 50,0 90,0 5,0 50,0
— not required
PROOF/ÉPREUVE © ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
ISO 15854:2022(E)
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

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

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 can possibly 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.
© ISO 2022 – All rights reserved PROOF/ÉPREUVE
---------------------- Page: 9 ----------------------
ISO 15854:2022(E)
6 Sampling

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

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.
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 1 000 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.

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

Flow-testing instrument, such as 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);
PROOF/ÉPREUVE © ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
ISO 15854:2022(E)

— base plate, metallic, flat smooth and parallel to the lower surface of the upper platen (see 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).

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 3 shall be such as to provide an axial compressive

force of (19,6 ± 0,1) N. The weight (Figure 1, Key 1) shall be separated from the surface of the water in

the bath by at least 20 mm. The upper platen (Figure 1, Key 3) shall be at least 5 mm thick for rigidity.

The optional dial gauge (Figure 1, Key 5) and locking screw (Figure 1, Key 6) can replace the micrometer

screw gauge for direct measurement of displacement (see 8.2.3).

The axial force calculation shall take into account the buoyancy of the immersed parts of the shaft and

upper platen (using the value of 0,01 N/ml) and the force exerted by the dial gauge or other measuring

device (Figure 1, Key 5), which force may be about 1 N and vary with its displacement if (as is usual) a

spring is present. Appropriate control of the water level in the water bath (8.2.2.9) is required.

The locking screw or equivalent device shall not cause damage to the shaft (Figure 1, Key 2) and thereby

impede its free movement.
© ISO 2022 – All rights reserved PROOF/ÉPREUVE
---------------------- Page: 11 ----------------------
ISO 15854:2022(E)

The base plate (Figure 1, Key 4) can conveniently be marked with a crosshair target, avoiding affecting

the surface of the central region, to enable the correct location of the test piece.

8.2.2.3 Pouring pan

For melting the wax, use a metal, glass or ceramic vessel, which may have a handle for convenience,

similar in functionality to the example shown in Figure 2.
NOTE A volume of 10 ml to 20 ml can be adequate.
Figure 2 — Example of a suitable pouring pan
8.2.2.4 Heat source

For melting the wax, any convenient low-power or low-temperature system can be used. For example,

— an infrared lamp with nominal power of (250 ± 50) W using a bulb of type R40 or similar;

— a hotplate giving good thermal contact with the base of the pouring pan (8.2.2.3);

— a hot-air oven allowing the wax to be observed.

For preheating, the mould (8.2.2.6), slab (8.2.2.7), glass plate (8.2.2.8) and an oven shall be used.

8.2.2.5 Thermometer

To measure the temperature of the molten wax, use an electronic thermometer with an accuracy

of ±0,2 °C and a reading resolution of ±0,1 K or better over the temperature range 20 °C to 100 °C, and

having a 95 % 10 K step change response time of less than 1 min.
8.2.2.6 Mould

For forming the flow test pieces, a metallic mould shall be used, for example made from stainless

steel or brass. This shall consist of a flat plate, (6,00 ± 0,01) mm thick, with parallel top and bottom

surfaces. The plate shall have one or more holes (10,00 ± 0,01) mm in diameter, with the axis of each

hole perpendicular to the surface of the plate. The upper and lower faces of the plate shall be finished

to roughness R ≤ 6,3 µm, and the hole wall shall be finished to roughness R ≤ 0,3 µm, according to

a a
ISO 4287.

NOTE It can be convenient to use a multiple mould such that several test pieces can be prepared at a time, for

example as shown in Figure 3.
PROOF/ÉPREUVE © ISO 2022 – All rights reserved
---------------------- Page: 12 ----------------------
ISO 15854:2022(E)
Dimensions in millimetres
Figure 3 — Example of a suitable mould for preparing flow test pieces
8.2.2.7 Glass slab

As a base for the mould, use a flat, polished glass slab, large enough for the purpose (i.e. larger than the

extent of the mould plate).

NOTE A dental mixing slab, approximately 150 mm long, 75 mm wide and 19 mm thick, is convenient.

8.2.2.8 Glass plate

For covering the mould (8.2.2.6), use a flat, polished glass plate, large enough for the purpose and

covered with thin, flat aluminium foil. The assembly shall be weighed.
8.2.2.9 Water bath

Use a rigid, stable water bath of sufficiently large volume, equipped with a temperature control device

and a stirring device that together ensure sufficient accuracy, stability and homogeneity of temperature,

according to the tolerances shown in Table 1, over the test volume.
8.2.2.10 Anti-vibration table

If vibration is discernible, or there is an appreciable risk of flow results being affected by vibration, then

an anti-vibration table, for example of the kind used to carry and isolate analytical balances, shall be

used to carry the water bath (8.2.2.9).
NOTE Vibration, such as from traffic and footfall,
...

Questions, Comments and Discussion

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