SIST EN ISO 6876:2026
(Main)Dentistry - Endodontic sealing material (ISO 6876:2025)
Dentistry - Endodontic sealing material (ISO 6876:2025)
This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry.
This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2).
The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy.
This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopeias can be made.
NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.
Zahnheilkunde - Endodontische Versiegelungswerkstoffe (ISO 6876:2025)
Dieses Dokument legt die Klassifizierung, Anforderungen und Prüfverfahren fest für endodontische Versiegelungswerkstoffe, die in der Zahnheilkunde verwendet werden.
Dieses Dokument gilt sowohl für Werkstoffe, die für die konventionelle orthograde endodontische Versiegelung (Typ 1) verwendet werden, als auch für Werkstoffe, die für andere endodontische Versiegelungsverfahren wie Apexifikation, Perforationsfüllung, Resorptionsbehandlung oder retrograde Wurzelendfüllung (Typ 2) verwendet werden.
Die endodontischen Versiegelungswerkstoffe vom Typ 2 dürfen für die Vitalpulpatherapie verwendet werden. Dieses Dokument enthält jedoch keine Anforderungen in Bezug auf die Vitalpulpatherapie.
Dieses Dokument legt keine Anforderungen oder Prüfverfahren für die Sterilität fest.
ANMERKUNG 1 Es kann auf geltende nationale Vorschriften und international anerkannte Arzneibücher verwiesen werden.
ANMERKUNG 2 Nationale Anforderungen an Sterilisationsverfahren können, falls vorhanden, angewendet werden. Es sind außerdem Normen zu Validierungsverfahren für Sterilisationsverfahren verfügbar: ISO 11737 1, ISO 11737 2 und ISO 11737 3.
Médecine bucco-dentaire - Matériaux de scellement endodontique (ISO 6876:2025)
Le présent document spécifie la classification, les exigences et les méthodes d’essai relatives aux matériaux de scellement endodontique utilisés en médecine bucco-dentaire.
Le présent document est applicable aux matériaux utilisés pour le scellement endodontique orthograde conventionnel (type 1) et aux matériaux utilisés pour d’autres procédures de scellement endodontique, comme l’apexification, l’obturation des perforations, le traitement de résorptions ou l’obturation rétrograde des extrémités du canal radiculaire (type 2).
Les matériaux de scellement endodontique de type 2 peuvent être utilisés pour la thérapie pulpaire. Cependant, le présent document ne traite pas de la thérapie pulpaire et n’inclut pas d’exigences à ce sujet.
Le présent document ne spécifie pas d’exigences ou de méthodes d’essai applicables à la stérilité.
NOTE 1 Il est possible de se référer aux réglementations nationales en vigueur et aux pharmacopées internationalement reconnues.
NOTE 2 Il est possible d’utiliser les exigences nationales concernant les procédés de stérilisation, si elles sont disponibles. Des normes sur les méthodes de validation des procédés de stérilisation sont également disponibles: ISO 11737-1, ISO 11737-2 et ISO 11737-3.
Zobozdravstvo - Endodontski zapiralni materiali (ISO 6876:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2026
Nadomešča:
SIST EN ISO 6876:2012
Zobozdravstvo - Endodontski zapiralni materiali (ISO 6876:2025)
Dentistry - Endodontic sealing material (ISO 6876:2025)
Zahnheilkunde - Endodontische Versiegelungswerkstoffe (ISO 6876:2025)
Médecine bucco-dentaire - Matériaux de scellement endodontique (ISO 6876:2025)
Ta slovenski standard je istoveten z: EN ISO 6876:2025
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 6876
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2025
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 6876:2012
English Version
Dentistry - Endodontic sealing material (ISO 6876:2025)
Médecine bucco-dentaire - Matériaux de scellement Zahnheilkunde - Endodontische
endodontique (ISO 6876:2025) Versiegelungswerkstoffe (ISO 6876:2025)
This European Standard was approved by CEN on 28 September 2025.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 6876:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 6876:2025) has been prepared by Technical Committee ISO/TC 106 "Dentistry"
in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by
DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2026, and conflicting national standards shall be
withdrawn at the latest by May 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 6876:2012.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 6876:2025 has been approved by CEN as EN ISO 6876:2025 without any modification.
International
Standard
ISO 6876
Fourth edition
Dentistry — Endodontic sealing
2025-11
materials
Médecine bucco-dentaire — Matériaux de scellement
endodontique
Reference number
ISO 6876:2025(en) © ISO 2025
ISO 6876:2025(en)
© ISO 2025
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.
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 6876:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 General .2
5.2 Appearance .3
5.3 Flow (Type 1 only) .3
5.4 Working time (Type 1 only) .3
5.5 Setting time .3
5.6 Film thickness (Type 1 only) . .3
5.7 Solubility and disintegration .3
5.8 Radiopacity .3
6 Sampling . 4
7 Test methods . 4
7.1 Test conditions .4
7.2 Appearance .4
7.2.1 General .4
7.2.2 Treatment of results .4
7.3 Flow (Type 1 materials) .4
7.3.1 General .4
7.3.2 Apparatus .4
7.3.3 Procedure .5
7.3.4 Treatment of results .6
7.4 Working time .6
7.4.1 General .6
7.4.2 Apparatus .6
7.4.3 Procedure .6
7.4.4 Treatment of results .7
7.5 Setting time .7
7.5.1 General .7
7.5.2 Apparatus .7
7.5.3 Preconditioning of the apparatus .8
7.5.4 Sample preparation .8
7.5.5 Procedure .8
7.6 Film thickness (Type 1 only) . .9
7.6.1 Apparatus .9
7.6.2 Procedure .9
7.6.3 Treatment of the results .9
7.7 Solubility and disintegration .10
7.7.1 General .10
7.7.2 Apparatus .10
7.7.3 Sample preparation .10
7.7.4 Procedure .11
7.7.5 Repetition test of solubility and dissolution . 12
7.7.6 Treatment of results . 13
7.8 Radiopacity . 13
7.8.1 General . 13
7.8.2 Apparatus . 13
7.8.3 Sample preparation .14
iii
ISO 6876:2025(en)
7.8.4 Procedure .14
7.8.5 Treatment of results .14
8 Marking, packaging and labelling .15
8.1 Marking . 15
8.2 Packaging . 15
8.3 Labelling . 15
Annex A (informative) Working time determination test for Type 1 materials . 17
Bibliography .20
iv
ISO 6876:2025(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 1, Filling and
Restorative Materials, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO
and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 6876:2012), which has been technically
revised.
The main changes to the previous edition are as follows:
— endodontic sealing materials, other than orthograde endodontic sealing material used with endodontic
obturating materials, have been included;
— two types of endodontic sealing materials have been defined and classified;
— mould material has been changed from gypsum to metal or other non-reactive materials for the setting
time test;
— test methods for flow, working time, setting times and solubility have been augmented for clarity and
convenience;
— ISO 13116 for the determination of radiopacity has been added as a normative reference;
— an alternative test method has been added for working time to Annex A.
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.
v
ISO 6876:2025(en)
Introduction
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological
risks are not included in this document but it is recommended that, for the assessment of such biological
risks, reference be made to ISO 7405 and ISO 10993-1.
vi
International Standard ISO 6876:2025(en)
Dentistry — Endodontic sealing materials
1 Scope
This document specifies the classification, requirements and test methods for endodontic sealing materials
used in dentistry.
This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1)
and materials used for other endodontic sealing procedures including apexification, perforation filling,
resorption treatment or retrograde root-end filling (Type 2).
The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does
not address or include requirements for vital pulp therapy.
This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopeias can be made.
NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of
validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.
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 3630-1, Dentistry — Endodontic instruments — Part 1: General requirements
ISO 13116:2014, Dentistry — Test method for determining radio-opacity of materials
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part
1: General requirements
ISO 20417, Medical devices — Information to be supplied by the manufacturer
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 3630-1 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
ISO 6876:2025(en)
3.1
endodontic obturating material
radiopaque dental material used in the form of a point, carrier-based obturating device, or injection material
used in combination with an endodontic sealing material (3.2) to fill voids and seal root canals during
orthograde obturation
Note 1 to entry: Endodontic obturating points are used with endodontic sealers.
[SOURCE: ISO 6877:2025, 3.2, modified — Note 1 to entry has been added.]
3.2
endodontic sealing material
material intended to permanently seal the root canal system usually used in combination with endodontic
obturating points during orthograde obturation, i.e. filling a root canal from the coronal part of a tooth,
or materials used for other endodontic sealing procedures including apexification, perforation filling,
resorption treatment or retrograde root-end filling
3.3
working time
period of time, measured from the start of mixing or dispensing of a single paste, during which it is possible
to manipulate the material without any adverse effects on its properties
Note 1 to entry: See 7.4 for more information on working time.
3.4
setting time
period of time, measured from the start of mixing or dispensing of a single paste, after which no indentation
change is observed with the Gillmore apparatus
Note 1 to entry: See 7.5.2.2 for more information on the Gillmore apparatus.
3.5
radiopacity
property of obstructing the passage of radiant energy, such as x-rays, the representative areas appearing
grey or white on an exposed film or digital sensor image
4 Classification
For the purposes of this document, endodontic sealing materials are classified into the following types based
on their intended use:
a) Type 1: Endodontic sealing material intended for orthograde obturation, usually in conjunction with
endodontic obturating material to fill and seal the root canal system.
b) Type 2: Endodontic sealing material used for endodontic sealing procedures other than orthograde
obturation including apexification, perforation repair, (internal and external) resorption or retrograde
root-end filling.
NOTE 1 Type 2 materials can selectively be used to seal root canal orifices.
NOTE 2 Type 2 materials generally have higher viscosity than Type 1 materials.
5 Requirements
5.1 General
When tested in accordance with the test methods specified in Clause 7, Type 1 and Type 2 materials shall
meet the performance requirements specified in Table 1.
ISO 6876:2025(en)
Table 1 — Requirements for endodontic sealing materials
Test Type 1 Type 2
Appearance Free from extraneous material
Flow (mm) ≥ 17 No requirement
a
Working time (mm) ≥ 17 No requirement
≤ Setting time, or
Setting time (h:min)
within the range stated by the manufacturer
Film thickness (µm) ≤ 50 No requirement
Solubility and disintegration (%) ≤ 3,0
Radiopacity (mm Al/mm) ≥ 3,0
a
Applicable to materials claimed by the manufacturer to have a working time of up to 30 min.
5.2 Appearance
The material shall have a uniform appearance when prepared and shall be free from extraneous matter. Test
in accordance with 7.2.
5.3 Flow (Type 1 only)
The unset Type 1 material shall have a diameter of 17 mm or larger when tested in accordance with 7.3.
5.4 Working time (Type 1 only)
For Type 1 materials that are claimed by the manufacturer to have a working time of up to 30 min, the
diameter of the flow test samples shall be 17 mm or larger in accordance with 7.4.3. The working time test is
not required for materials that are claimed by the manufacturer to have a working time of more than 30 min.
5.5 Setting time
The setting time shall not be more than the setting time stated by the manufacturer when tested in
accordance with 7.5. If a range is stated for setting time by the manufacturer, the setting time shall be within
the range.
5.6 Film thickness (Type 1 only)
Each sample of Type 1 materials shall have a film thickness of not more than 50 µm when tested in accordance
with 7.6.
5.7 Solubility and disintegration
The solubility and disintegration of Type 1 and Type 2 materials shall not exceed 3,0 % by mass when tested
in accordance with 7.7.
After the test, the samples shall show no evidence of disintegration when examined visually without
magnification.
5.8 Radiopacity
Endodontic sealing materials shall have a mean radiopacity equal to or greater than 3,0 mm aluminium,
when tested in accordance with 7.8 and ISO 13116 using 1-mm thick samples.
ISO 6876:2025(en)
6 Sampling
Use one or more retail packages from the same batch (lot identification) containing sufficient material to
carry out the specified tests, plus an allowance for repeats, if necessary. It is recommended to procure at
least 25 g of material for testing.
7 Test methods
7.1 Test conditions
7.1.1 Conduct all tests except setting time and solubility at (23 ± 2) °C. Condition materials and apparatus
at this temperature for 1 h prior to testing, unless the methods require otherwise.
7.1.2 Weigh any samples to verify that the preparation of successive samples tested is uniform and
identical. Weigh powder and liquid components to ±0,001 g with a laboratory balance (7.3.2.3) before mixing
to ensure sample consistency. Verify weights for unit doses, such as powder in a capsule or liquid in a single-
dose container. The weights of materials dispensed from dual syringes should be verified to ensure sample
consistency. Weigh the successive samples and ensure the weights agree within ±10 %.
7.1.3 Mix or prepare all components of the material in accordance with the manufacturer’s instructions
for use, which can require special mixing equipment. If a material does not require mixing, for example
because it is a single premixed paste, start the physical property tests when the material is dispensed.
7.2 Appearance
7.2.1 General
Examine the material for a uniform appearance, absence of extraneous matter and freedom from the
separation of a paste component when extruded. Use normal visual acuity without magnification.
NOTE The separation of a paste is the appearance of a thinner liquid, separate and adjacent to the bulk paste.
7.2.2 Treatment of results
The uniform appearance and absence of extraneous matter in the material are required to pass this test.
The appearance of paste separation shall be reported.
7.3 Flow (Type 1 materials)
7.3.1 General
The test consists of placing a specified volume of material between two glass plates, placing a specified load
on the upper plate and measuring the diameter of the resulting disc of the material.
7.3.2 Apparatus
7.3.2.1 Two glass plates, at least 40 mm × 40 mm, one of which has a mass of (20 ± 2) g and is designated
as the upper plate. The second plate is designated as the lower plate.
7.3.2.2 Weight, having a mass of 100 g such that the total mass of the weight and the upper plate equals
(120 ± 2) g.
7.3.2.3 Laboratory balance, with a precision of 0,001 g and capacity suitable for weighting materials.
ISO 6876:2025(en)
7.3.2.4 Ruler, or similar device, accurate to 0,5 mm.
7.3.2.5 Volume measure, having a capacity equal to or larger than 0,05 mL, such as a small scoop or other
shapes for the mass method (7.3.3.2). For the volume method (7.3.3.3), use a graduated syringe capable of
delivering (0,05 ± 0,005) mL of the mixed material.
7.3.3 Procedure
7.3.3.1 General
Use either the mass method (7.3.3.2) or the volume method (7.3.3.3) for dispensing the required volume of
material.
NOTE It is possible that the mass method wastes less material than the volume method.
7.3.3.2 Mass method for dispensing
7.3.3.2.1 Weigh the calibrated volume measure (7.3.2.5) ( m ), whose precise volume is known to the
tester, using the laboratory balance (7.3.2.3).
7.3.3.2.2 Fill the the calibrated volume measure (7.3.2.5) with freshly mixed test material and reweigh it (
m ) with the laboratory balance (7.3.2.3).
7.3.3.2.3 Calculate the density (ρ) of the material according to Formula (1) to two decimal places, e.g.
1,23 g/mL:
mm−
()
ρ = (1)
V
where
ρ is the density, expressed in g/mL;
V is the known volume of the calibrated device, expressed in mL.
7.3.3.2.4 Calculate the mass required for the flow test, m , of 0,05 mL by multiplying the calculated
flow
density (ρ) by 0,05 as Formula (2):
m = ρ × 0,05 (2)
flow
NOTE The mass calculated for the flow test, m , is equivalent to a volume of 0,05 mL.
flow
7.3.3.2.5 Proceed to 7.3.3.4.
7.3.3.3 Volume method for dispensing
7.3.3.3.1 Fill a graduated syringe (7.3.2.5), capable of dispensing (0,05 ± 0,005) mL, with the material
ready for testing. Bubbles and other gaps in the filled calibrated syringe should be avoided to prevent
mismeasurement of the 0,05 mL.
NOTE It is possible that the volume method requires the mixing and transfer of components to a syringe. This
transfer can be difficult, time-consuming and wasteful.
7.3.3.3.2 Proceed to 7.3.3.4.
ISO 6876:2025(en)
7.3.3.4 Flow test procedure
7.3.3.4.1 Dispense (0,05 ± 0,005) mL of Type I material using either the mass (7.3.3.2) or volume method
(7.3.3.3) centrally onto the lower glass plate (7.3.2.1). If using the volume method, ensure that bubbles are
not present in the dispensing syringe.
7.3.3.4.2 At (180 ± 10) s from the start of mixing the components or dispensing the premixed paste, place
the upper glass plate (7.3.2.1) and the weight (7.3.2.2) centrally onto the dispensed material.
7.3.3.4.3 Remove the weight (7.3.2.2) 7 min after its placement, but do not remove the upper glass plate.
7.3.3.4.4 Without pressing on the upper glass plate, use the ruler (7.3.2.4) to measure the major and minor
diameters to the nearest millimetre.
7.3.3.4.5 If the major and minor diameters agree within 1 mm, record the mean of the two diameters to
the nearest 0,5 mm as the flow.
7.3.3.4.6 If the major and minor diameters for each test do not agree within 1 mm, disregard the results
and repeat the test with fresh material.
7.3.3.4.7 Repeat the test with fresh samples at least two more times and calculate the mean value of each
test to the nearest 0,5 mm. Record the mean diameter of all tests.
7.3.4 Treatment of results
Each mean diameter of the flow test results shall conform with Table 1. If the results conform with Table 1,
report the mean value to the nearest 0,5 mm; otherwise, the material fails.
7.4 Working time
7.4.1 General
This working time test uses the same apparatus and concepts for flow testing (7.3). For Type 1 materials
that have a working time, stated by the manufacturer, as not more than 30 min, conformity with the
requirement given in 5.4 shall be determined in accordance with 7.4.4.1. The working time is verified by
preparing samples for the flow test and placing the weight on the sample within 15 s before the end of the
stated working time. A working time determination test is given for information in Annex A.
7.4.2 Apparatus
Use the apparatus described in 7.3.2.
7.4.3 Procedure
7.4.3.1 Prepare the Type 1 materials which have a working time of less than 30 min according to the
manufacturer’s instructions.
7.4.3.2 Use either the mass method (7.3.3.2) or volume method (7.3.3.3) of the flow test method to
dispense a volume of (0,05 ± 0,005) mL of the material onto the lower glass plate (7.3.2.1).
7.4.3.3 Wait until 15 s before the end of the manufacturer’s stated working time. Then, place the upper
glass plate (7.3.2.1) and the weight (7.3.2.2) on the sample. If a manufacturer states a range for the working
time, choose the longest time in the range for testing the flow.
ISO 6876:2025(en)
7.4.3.4 Seven min after placing the weight, remove the weight. Without removing or pressing on the upper
glass plate, use the ruler (7.3.2.4) to measure the major and minor diameters to the nearest millimetre.
7.4.3.5 If the major and minor diameters agree within 1 mm, record the mean of the two diameters to the
nearest 0,5 mm.
7.4.3.6 If the major and minor disc diameters for each test do not agree within 1 mm, disregard the
measurements and repeat the test with fresh material.
7.4.3.7 Repeat the test with fresh samples at least two more times and calculate the mean value of each
test to the nearest 0,5 mm. Record the mean diameter of all tests.
7.4.4 Treatment of results
7.4.4.1 For materials that have a stated working time of not more than 30 min, if the mean diameter of
each test is 17 mm or greater, the material is deemed to pass.
7.4.4.2 To measure or determine a working time for Type 1 materials, see Annex A.
7.5 Setting time
7.5.1 General
Diverse chemical reaction mechanisms are used for hardening and setting endodontic sealing materials
that vary from minutes to hours. No one “setting” test method demonstrates the same degree of the setting
reaction for all materials. For practicality, the two Gillmore indenters in 7.5.2.2 are used to determine setting
times by indentation.
The setting time of Type 1 materials is determined using Gillmore indenter A (7.5.2.2.1). The setting time of
Type 2 materials is determined using Gillmore indenter B (7.5.2.2.2).
7.5.2 Apparatus
7.5.2.1 Cabinet, capable of being maintained at (37 ± 1) °C and not less than 95 % relative humidity (RH).
The RH should be checked with a hygrometer put inside.
NOTE An incubator for cell culture can be used as a cabinet. An airtight container containing water can be used to
house the samples within the cabinet. An enclosed water bath capable of being maintained at (37 ± 1) °C can be used.
7.5.2.2 Gillmore apparatus, with a base and two horizontal arms to hold two Gillmore indenters that can
apply an indentation perpendicular to the surface of the specimen. The indenters’ tips shall be cylindrical
over a length of at least 5 mm. The tip face should be planar with a square edge and perpendicular to its
longitudinal axis.
7.5.2.2.1 Indenter A, with a mass of (100,0 ± 0,5) g and a diameter of (2,0 ± 0,1) mm.
7.5.2.2.2 Indenter B, with a mass of (400,0 ± 0,5) g and a diameter of (1,0 ± 0,1) mm.
7.5.2.3 Ring mould, having an internal diameter of (10,0 ± 0,1) mm and a thickness of (2,0 ± 0,1) mm made
of stainless steel or other material such as polytetrafluoroethylene or silicone.
NOTE A mould with a disk-shaped cavity with an internal diameter of (10,0 ± 0,1) mm and a depth of (2,0 ± 0,1) mm
can be used.
7.5.2.4 Flat glass plate, approximately 1 mm thick. A glass microscope slide is suitable.
ISO 6876:2025(en)
7.5.2.5 Metal block, with dimensions of at least 8 mm × 20 mm × 10 mm.
7.5.2.6 Laboratory balance, with a precision of ±0,001 g and capacity suitable for weighing the materials.
7.5.3 Preconditioning of the apparatus
Equilibrate the items 7.5.2.2 to 7.5.2.5 within the cabinet (7.5.2.1) for at least 1 h before tests. Keep the items
in the cabinet during the tests.
7.5.4 Sample preparation
7.5.4.1 Place the ring mould on the glass plate or use a cavity mould. Mix the components or dispense a
single paste according to the manufacturer’s instructions and fill the mould to create a flat surface with the
material. Measuring the weights of each component being mixed using the balance (7.5.2.6) is necessary to
ensure that all samples contain the same proportions of the components.
7.5.4.2 Within (120 ± 10) s from the start of mixing the components or dispensing the premixed paste,
place the filled moulds on the metal block (7.5.2.5) in the cabinet (7.5.2.1) ensuring high humidity conditions
for the specimens. For materials that have an oxygen-inhibited surface layer, place a cover over the material,
such as a glass microscope slide (7.5.2.4) or a polyethylene sheet (7.7.2.4). Ensure the cover is relocated
between indentation tests.
7.5.5 Procedure
7.5.5.1 Setting time for Type 1 material
7.5.5.1.1 Choose a time for indentation based on the stated setting time for Type 1 materials in the
manufacturer’s information. Perform the first indentation between 90 % and 100 % of the setting time
stated by the manufacturer. Testing each minute is unacceptable, except for materials that set within 10 min.
If the setting time is estimated to be about 1 h, every 10 min can be appropriate.
NOTE The testing interval can be longer for samples that require hours or days to set.
7.5.5.1.2 For single-paste premixed cement-based materials, if necessary, use absorbent tissue to remove
excess organic liquid on the surface before testing.
7.5.5.1.3 Open the cabinet and place the sample in the mould on the base of the Gillmore apparatus
(7.5.2.2) in the cabinet. Gently lower the Gillmore indenter A (7.5.2.2.1) connected to the Gillmore apparatus
onto the horizontal surface of the material in the cabinet (7.5.2.1). Do not apply the load by hand. Remove the
cover of materials that have an oxygen-inhibited surface layer before indenting and replace after inspection.
7.5.5.1.4 Lift the indenter A (7.5.2.2.1) and determine if the indentation can be seen. If an indentation is
seen on the surface, the setting time has not been reached. Clean the indenter tip and replace the mould in
the cabinet (7.5.2.1). Do not perform the indentations in such frequent increments of time that the sample
does not maintain 37 °C.
7.5.5.1.5 At later intervals, repeat the indentation in new areas until no indentation is visible with the
naked eye, at which point the setting time is reached. If the indentation does not show further change, the
[17]
setting time can be recorded . Record the setting time as the time at which no indentations are seen or no
further changes in indentations are observed, from the start of preparation of the material (7.5.4.1).
7.5.5.1.6 Carry out the test with fresh samples at least two more times.
NOTE Temperature variations due to frequent opening of the cabinet affect the test results. To reduce the opening
duration of the cabinet, the tests can be performed consecutively instead of simultaneously. Longer intervals between
indentations reduce the temperature variations incurred by frequent opening of the cabinet.
ISO 6876:2025(en)
7.5.5.2 Setting time for Type 2 material
Follow the test method 7.5.5.1 for the Type 2 materials using indenter B (7.5.2.2.2).
7.5.5.3 Treatment of the results
Record the results of all tests (7.5.5.1 or 7.5.5.2), the mean and the range. Report how frequently the material
was tested. The mean of the test results shall conform with Table 1.
7.6 Film thickness (Type 1 only)
7.6.1 Apparatus
7.6.1.1 Two, flat glass plates, square or circular, having a contact surface area of (200 ± 25) mm and a
uniform thickness of not less than 5 mm.
7.6.1.2 Loading device, to gradually and vertically apply the final force of (150 ± 2) N onto the specimen
via the upper glass plate without rotating the plate during its application.
NOTE Placing a weight of (15,3 ± 0,2) kg on the upper glass is unacceptable because it cannot be consistently or
gradually applied.
7.6.1.3 Micrometer or similar measuring instrument, accurate to 0,001 mm.
7.6.2 Procedure
7.6.2.1 Measure the combined thickness (reading A), of the two glass plates (7.6.1.1) in contact, to an
accuracy of 0,001 mm.
7.6.2.2 Place a portion of the Type 1 material onto the centre of the lo
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