prEN ISO 4823

Dentistry - Elastomeric impression and bite registration materials (ISO/DIS 4823:2020)

Zahnheilkunde - Elastomere Abformmaterialien und Bissregistriermassen (ISO/DIS 4823:2020)

Dieses Dokument spezifiziert die Anforderungen und ihre Prüfverfahren für elastomere Abformmaterialien und Bissregistriermassen.
ANMERKUNG Dieses Dokument geht nicht auf mögliche biologische Gefahren ein, die mit den Materialien in Zusammenhang stehen. Zur Beurteilung möglicher biologischer Risiken wird empfohlen, ISO 7405 und ISO 10993 heranzuziehen.

Zobozdravstvo - Elastomerni materiali za odtise in ugriz (ISO/DIS 4823:2020)

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 4823:2020
01-julij-2020
Zobozdravstvo - Elastomerni materiali za odtise in ugriz (ISO/DIS 4823:2020)

Dentistry - Elastomeric impression and bite registration materials (ISO/DIS 4823:2020)

Zahnheilkunde - Elastomere Abformmaterialien und Bissregistriermassen (ISO/DIS
4823:2020)
Ta slovenski standard je istoveten z: prEN ISO 4823
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 4823:2020 en,fr,de

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

---------------------- Page: 1 ----------------------
oSIST prEN ISO 4823:2020
---------------------- Page: 2 ----------------------
oSIST prEN ISO 4823:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 4823
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-04-23 2020-07-16
Dentistry — Elastomeric impression and bite registration
materials
ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 4823:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 4823:2020
ISO/DIS 4823:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 4823:2020
ISO/DIS 4823:2020(E)
Contents Page

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

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

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

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

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

5 Requirements for packaging, labelling, and information in manufacturer's instructions .....3

5.1 Packaging requirements ................................................................................................................................................................. 3

5.2 Labelling requirements ................................................................................................................................................................... 3

5.2.1 Outer packages (containing one or more primary containers) .................. ............................. 3

5.2.2 Primary containers within outer packaging ............................................................................................ 3

5.3 Requirements for information in manufacturer's instructions .................................................................... 3

5.3.1 General...................................................................................................................................................................................... 3

5.3.2 Identifying information ........................................................................................................................................... ... 4

5.3.3 Specific instructions for use ................................................................................................................................... 4

5.4 Requirements for characteristics and properties ..................................................................................................... 5

5.4.1 Component colours (hand-spatulated or hand-kneaded mixes) ........................................... 5

5.4.2 Mixing time (hand-spatulated or hand-kneaded mixes)............................................................... 5

5.4.3 Consistency ........................................................................................................................................................................... 5

5.4.4 Working time....................................................................................................................................................................... 5

5.4.5 Detail reproduction ....................................................................................................................................................... 5

5.4.6 Linear dimensional change ..................................................................................................................................... 5

5.4.7 Compatibility with gypsum .................................................................................................................................... 5

5.4.8 Elastic recovery ................................................................................................................................................................. 5

5.4.9 Strain-in-compression ................................................................................................................................................ 5

5.4.10 Minimum time in the oral cavity for bite registration materials ............................................ 5

5.4.11 Compression set of bite registration materials ..................................................................................... 5

5.4.12 Hardness of bite registration materials ....................................................................................................... 6

6 Pre-test planning approaches ................................................................................................................................................................. 6

6.1 Sampling ....................................................................................................................................................................................................... 6

6.2 Pre-test product examinations .................................................................................................................................................. 6

6.2.1 Examinations for compliance with labelling requirements ....................................................... 7

6.2.2 Examinations for effectiveness of the packaging ................................................................................. 7

6.2.3 Examinations for compliance with requirements for instructions for use ................... 7

6.3 Essential pre-test preparatory practices .......................................................................................................................... 7

6.3.1 Laboratory conditions ................................................................................................................................................. 7

6.3.2 Apparatus function verification steps ........................................................................................................... 7

6.3.3 Volume of materials to be mixed for each specimen ........................................................................ 8

6.3.4 Order for conducting examinations and tests ........................................................................................ 8

6.3.5 Standardized approaches to proportioning, mixing, and handling of hand

mixed materials to be tested.................................................................................................................................. 8

6.3.6 Timing for the specimen preparation and test procedures ........................................................ 8

6.3.7 Simulated oral time/temperature treatment of specimens formed in

completely closed mould assemblies ............................................................................................................. 8

6.4 Pass/fail determinations ................................................................................................................................................................ 8

6.5 Expression of test results ............................................................................................................................................................... 8

7 Test methods — Specific ............................................................................................................................................................................... 8

7.1 Mixing time................................................................................................................................................................................................. 8

7.1.1 Apparatus ............................................................................................................................................................................... 8

7.1.2 Specimen preparation and test procedure (five specimens) ..................................................... 9

7.1.3 Pass/fail determination and expression of results............................................................................. 9

7.2 Consistency ................................................................................................................................................................................................ 9

7.2.1 Apparatus and materials ........................................................................................................................................... 9

© ISO 2020 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 4823:2020
ISO/DIS 4823:2020(E)

7.2.2 Advance preparation steps...................................................................................................................................... 9

7.2.3 Specimen preparation and test procedure (5 specimens) .......................................................10

7.2.4 Pass/fail determination and expression of results..........................................................................10

7.3 Working-time ........................................................................................................................................................................................10

7.3.1 Apparatus ............................................................................................................................................................................10

7.3.2 Working time test .........................................................................................................................................................11

7.4 Detail reproduction ..........................................................................................................................................................................12

7.4.1 Apparatus and materials ........................................................................................................................................12

7.4.2 Specimen preparation ..............................................................................................................................................12

7.4.3 Test procedure ................................................................................................................................................................13

7.4.4 Pass/fail determination and expression of results..........................................................................13

7.5 Linear dimensional change .......................................................................................................................................................13

7.5.1 Apparatus and materials ........................................................................................................................................13

7.5.2 Test block line-length measurement procedure ................................................................................14

7.5.3 Specimen preparation ..............................................................................................................................................14

7.5.4 Test specimen measurement ..............................................................................................................................14

7.6 Compatibility with gypsum .......................................................................................................................................................15

7.6.1 Apparatus and materials ........................................................................................................................................15

7.6.2 Specimen preparation ..............................................................................................................................................16

7.6.3 Test procedure ................................................................................................................................................................16

7.6.4 Pass/fail determination and expression of results..........................................................................16

7.7 Elastic recovery ...................................................................................................................................................................................16

7.7.1 Apparatus and materials ........................................................................................................................................16

7.7.2 Specimen preparation ..............................................................................................................................................17

7.7.3 Test procedure ................................................................................................................................................................18

7.7.4 Calculation of results .................................................................................................................................................18

7.7.5 Pass/fail determination and expression of results..........................................................................18

7.8 Strain in compression ....................................................................................................................................................................18

7.8.1 Apparatus ............................................................................................................................................................................18

7.8.2 Specimen preparation ..............................................................................................................................................18

7.8.3 Test procedure ................................................................................................................................................................19

7.8.4 Calculation of results .................................................................................................................................................19

7.8.5 Pass/fail determination and expression of results..........................................................................19

7.9 Minimum time in the oral cavity and compression set for bite registration materials .........19

7.9.1 Apparatus ............................................................................................................................................................................19

7.9.2 Preparation of test specimens ...........................................................................................................................19

7.9.3 Test procedure ................................................................................................................................................................19

7.9.4 Evaluation ...........................................................................................................................................................................20

7.9.5 Pass/fail determination and expression of results..........................................................................20

7.10 Hardness of bite registration materials ..........................................................................................................................20

7.10.1 Apparatus ............................................................................................................................................................................20

7.10.2 Preparation of test specimens ...........................................................................................................................20

7.10.3 Procedure (according to ISO 48-4:2018).................................................................................................20

7.10.4 Evaluation ...........................................................................................................................................................................21

7.10.5 Pass/fail determination and expression of results..........................................................................21

Annex A (normative) Figures cited in this International Standard ...................................................................................22

Annex B (normative) Standardized hand mixing methods ........................................................................................................31

Bibliography .............................................................................................................................................................................................................................34

iv © ISO 2020 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 4823:2020
ISO/DIS 4823:2020(E)
Foreword

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

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

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

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

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

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

electrotechnical standardization.

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

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

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

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

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

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

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

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

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

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO's adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.

The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic

materials.

This fifth edition cancels and replaces the fourth edition (ISO 4823:2015), which has been technically

revised and enhanced with regard to elastomeric bite registration materials. The following changes

have been applied:

— title and scope changed to reflect inclusion of elastomeric bite registration materials;

— added ISO 48-4:2018 as a normative reference;

— added description of minimum time in the oral cavity for bite registration materials;

— added description of hardness of bite registration materials.
© ISO 2020 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 4823:2020
---------------------- Page: 8 ----------------------
oSIST prEN ISO 4823:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 4823:2020(E)
Dentistry — Elastomeric impression and bite registration
materials
1 Scope

This document specifies the requirements and their test methods for elastomeric impression and bite

registration materials.

NOTE This document does not address possible biological hazards associated with the materials. Therefore,

interested parties are encouraged to explore ISO 7405 and ISO 10993 for assessment of such 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 undated references, the latest edition of the referenced

document (including any amendments) applies.

ISO 48-4:2018, Rubber, vulcanized or thermoplastic — Determination of hardness — Part 4: Indentation

hardness by durometer method (Shore hardness)
ISO 1942, Dentistry — Vocabulary
ISO 6873:2013, Dentistry — Gypsum products
3 Terms and definitions

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

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

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

degree of firmness with which particles of a material, prepared for use, cohere so as to allow the

material to flow, or resist flow
3.2
elastic recovery

elastic properties required to recover adequately after deformation

3.3
extrusion mixing

method by which two or more material components are extruded simultaneously from their separate

primary containers through a mixing nozzle from which the material components emerge as a

homogeneous mixture
3.4
hand mixing

method of mixing the components of a material by means of manual kneading or spatulation

© ISO 2020 – All rights reserved 1
---------------------- Page: 9 ----------------------
oSIST prEN ISO 4823:2020
ISO/DIS 4823:2020(E)
3.5
hardness
Shore hardness according to ISO 48-4:2018 Type A
3.6
minimum time in the oral cavity

minimum time span the material has to stay in the oral cavity before removal to sufficiently minimize

deformation
3.7
mixing time

time, measured from first contact between different components of a material being mixed, required

to achieve a homogeneous mixture when the components are mixed according to the manufacturer’s

instructions

Note 1 to entry: The time of first contact between extrusion-mixed material components is defined as the time

when the material components can be seen entering into the mixing nozzle.
3.8
outer package

wrapping or carton, which may be required by law or a standard to bear specified labelling, used to

cover one or more primary containers in preparation for retail marketing
3.9
primary packaging
container designed to come into direct contact with the product

[SOURCE: ISO 21067:2007, 2.2.2, modified — “packaging” replaced by “container” in the definition.]

3.10
strain in compression

〈elastic impression materials〉 flexibility/stiffness property ranges of materials so as to determine

whether the set materials, when formed as impressions, can be removed from the mouth without injury

to impressed oral tissues and will have adequate stiffness in the more flexible portions of impressions

to resist deformation when model-forming products are poured against them
3.11
working time

period of time beginning with the commencement of mixing and ending before the material being

mixed has begun to exhibit elastic properties that will prevent the material from being manipulated

as required to form an impression or a mould having the desired surface detail and dimensional

characteristics
4 Classification

Materials covered by this International Standard are classified according to the following

consistencies determined immediately after completion of mixing according to the manufacturer’s

instructions (see 5.3):
— Type 0: putty consistency;
— Type 1: heavy-bodied consistency;
— Type 2: medium-bodied consistency;
— Type 3: light-bodied consistency;
— Type B: bite registration materials.
2 © ISO 2020 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 4823:2020
ISO/DIS 4823:2020(E)
5 Requirements for packaging, labelling, and information in manufacturer's
instructions
5.1 Packaging requirements

No packaging requirements are specified in this International Standard, but it is important for

manufacturers to take into account that the packaging should be such that it will not contaminate

or permit contamination of ingredients of the material components during recommended storage

conditions. Structure of the primary packaging should also be such that no leakage or inadvertent

extrusion of the contents can occur during storage and such that the containers will not rupture during

use of the extrusion methods recommended by the manufacturer.
5.2 Labelling requirements
5.2.1 Outer packages (containing one or more primary containers)

Labelling of the outer packaging prepared for retail marketing containing one or more primary

containers shall bear the following information:
a) recommended storage conditions for the unopened package;
b) brand name;

c) name and address of the manufacturer or the name of another company authorized by the

manufacturer to market the material under a different brand name;

d) identification of the consistency of the material as putty, heavy-bodied, medium-bodied, or light-

bodied (see Clause 4) (the type number may also be included);
e) manufacturer's batch reference(s);

f) USE BEFORE DATE, identified as such, beyond which the material may not exhibit its best

properties. The date shall be expressed as a six-digit number, for example, 2014-09, where the first

four digits indicate the year (2014) and the last two digits indicate the month (September);

g) minimum volume that would result from mixing the entire component contents included in the

outer package.
5.2.2 Primary containers within outer packaging
Labels for primary containers shall bear the following information:
a) brand name;

b) name of the manufacturer or name of another company authorized to market the material under a

different brand name;

c) component identification (not required when the components for extrusion mixing are supplied in

separate but joined primary containers);
d) manufacturer’s batch references.
5.3 Requirements for information in manufacturer's instructions
5.3.1 General

Each package in which the components of an impression material are prepared for retail marketing shall

be accompanied by the instructions and other information needed to ensure optimum performance of

the material in clinical practice
© ISO 2020 – All rights reserved 3
---------------------- Page: 11 ----------------------
oSIST prEN ISO 4823:2020
ISO/DIS 4823:2020(E)
5.3.2 Identifying information
The following identifying information is required:
a) trade name or brand name of the product;

b) chemical nature of the elastomeric system: for example, polyether, polysulfide, silicone

(condensation type), or silicone (vinyl polysiloxane, addition type).
5.3.3 Specific instructions for use
Where applicable, the specific instructions for use shall include the following:

a) recommended storage conditions after the initial opening of the primary containers;

b) statements indicating that working time and other characteristics of the material can be affected

significantly by the following factors, as may be applicable:
— room temperature variations;
— variations in the speed and friction involved in mixing;
...