oSIST prEN ISO 7551:2026
(Main)Dentistry - Endodontic absorbent points (ISO/DIS 7551:2026)
- Abstract
This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points.
Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations can be made.
Reference is made to internationally accepted pharmacopoeia.
NOTE 2 National requirements can apply.
Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.
- Status
- Not Published
- Public Enquiry End Date
- 30-Jul-2026
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 4020 - Public enquire (PE) (Adopted Project)
- Start Date
- 11-Jun-2026
- Due Date
- 29-Oct-2026
- Completion Date
- 03-Aug-2026
oSIST prEN ISO 7551:2026 is a CEN draft for dentistry, titled Dentistry - Endodontic absorbent points (ISO/DIS 7551:2026). It specifies requirements and test methods for sterilized absorbent points used in endodontic procedures, including how their sizes are designated by number and colour so manufacturers, laboratories, and buyers can identify and verify the product they need. The document also covers marking, packaging and instructions for use, while sterility claims and biological-risk assessment are handled separately.
What does oSIST prEN ISO 7551:2026 specify?
oSIST prEN ISO 7551:2026 specifies the product requirements, test methods, size designation system, and product information for endodontic absorbent points. It applies to points that have been sterilized once by a method approved by the manufacturer, even though absorbent points may be marketed sterilized or non-sterilized.
The document is organized into seven clauses:
- Scope
- Normative references
- Terms and definitions
- Requirements
- Procurement of samples
- Measurement and test methods
- Product information
It also uses tables and figures to define sizes, colour coding, tolerances, test data, and label content. The scope notes that the document does not set sterility test requirements, although a manufacturer’s claim that an unopened pack is sterile remains the manufacturer’s responsibility.
What are the key requirements of oSIST prEN ISO 7551:2026?
oSIST prEN ISO 7551:2026 sets a practical specification for the shape, dimensions, absorption behaviour, disintegration resistance, and package information of absorbent points. In use, that means a manufacturer has to control both the physical product and the information supplied with it.
Product form, size and taper
An absorbent point shall be smooth, uniform in appearance, and free from extraneous matter and projecting fibres. Its overall length shall be at least 28 mm unless the manufacturer states another length, in which case the product shall meet that stated length.
The document distinguishes standard absorbent points, greater taper absorbent points, variable taper absorbent points, and auxiliary absorbent points. Standard, greater taper, and variable taper products use a numerical size designation combined with a taper designation, while auxiliary absorbent points are outside the nominal size designation requirements.
The size system matters in practice because it lets users choose points that fit the prepared canal and match the expected file or obturating-point family. Tables 1 to 3 define the size ranges, dimensions, and colour coding used for this identification.
Taper, tip and measurement control
oSIST prEN ISO 7551:2026 requires the tip to be rounded, conical, or blunt, and allows the neck to be tapered, cylindrical, or a combination of both. For standard and greater taper points, the taper shall be uniform over at least the first 16 mm from the tip. Variable taper points use manufacturer-declared reference locations and taper values near the tip.
The taper and nominal size are checked by measuring diameters at specified positions and calculating the taper from those measurements. In practice, this means the manufacturer must be able to trace the declared size back to measurable dimensions, and test laboratories must use the specified measuring approach rather than visual judgment alone.
Functional performance and acceptance testing
The absorbent point shall absorb liquid to a height of at least 10 mm above the liquid level. It shall also resist visible disintegration or shape change when immersed in water for the stated short exposure and during removal with forceps.
Sampling and test conditions are controlled. Testing is carried out after conditioning at the specified temperature and humidity, and non-sterile points are sterilized once before testing as recommended by the manufacturer. The acceptance rule is based on testing 10 points, with a further 10-point retest when 9 of the first 10 pass. That approach matters because it gives a clear batch-acceptance rule for quality control.
Marking, labelling, packaging and sterility claims
The nominal size designation or colour code shall be marked on the non-tip end. Packaging and labelling information is specified in clause 7 and Table 4, including the trade name, manufacturer identification, storage conditions, lot identification, product identification, and the number of points in each container.
Where the package is sterile or the manufacturer claims sterility for the unopened pack, the marking requirements become more specific, and the responsibility for that sterility claim remains with the manufacturer. The document also requires instructions for use to state the intended use, contraindications, warnings, precautions, adverse reactions if applicable, usage instructions, and the edition date.
What terms does oSIST prEN ISO 7551:2026 define?
oSIST prEN ISO 7551:2026 defines the main terms used to describe absorbent points so that size, taper, and shape are understood consistently.
- Absorbent point - an elongated preformed cone or cylinder made to absorb liquids from a root canal, and it may also be used briefly to apply a small amount of disinfectant.
- Nominal size designation - the tip size, designated as D and expressed in hundredths of a millimetre.
- Taper - the percentage increase in diameter along the length of the absorbent point from the tip.
- Standard absorbent point - an absorbent point with a uniform 02 taper over the first 16 mm from the tip.
- Greater taper absorbent point - an absorbent point with a uniform taper greater than 02 over the first 16 mm from the tip.
- Variable taper absorbent point - an absorbent point whose taper changes over the first 16 mm from the tip.
- Auxiliary absorbent point - an absorbent point not covered by the standard, greater taper, or variable taper categories, and not subject to nominal size designation requirements.
- Unit pack - the smallest distributed pack, containing one or more sizes of absorbent points.
Who uses oSIST prEN ISO 7551:2026?
oSIST prEN ISO 7551:2026 is used by manufacturers of dental absorbent points, quality control and test laboratories, and buyers or procurement teams that need to specify product size, packaging, and labelling. Dentists and endodontic users also rely on it indirectly because it standardizes the size and colour system for the points they select in root canal work. Regulatory and conformity-assessment staff can use it when checking product claims, batch information, and package presentation.
What changed in oSIST prEN ISO 7551:2026 from the previous edition?
oSIST prEN ISO 7551:2026 is the second edition and it replaces ISO 7551:1996. The foreword states that it has been technically revised.
The main changes are:
- the format has been updated
- absorbent points other than standard taper absorbent points have been added
- tables for greater taper dimensions have been updated
- the size system has been aligned with obturating points in ISO 6877 and instruments from the ISO 6360 series
- the term “numbering system” has been changed to “nominal size designation” of the tip
- Figure 2 has been removed
Which standards are used with oSIST prEN ISO 7551:2026?
oSIST prEN ISO 7551:2026 states that there are no normative references. It does, however, name several standards that support its use:
- ISO 1942 and ISO 3630-1 - provide terms and definitions used in dentistry and related dimensional conventions
- ISO 3630-1 - is also used for marking and measurement-related compatibility
- ISO 20417 - supports the manufacturer information given on labels
- ISO 15223-1 - provides graphical symbols for labels
- ISO 6360-1 - is referenced for the symbol for “Sterile”
- ISO 8601-1 - is used for expressing the expiry date
- ISO 11737-1, ISO 11737-2 and ISO 11737-3 - are named as standards for validating sterilization processes
- ISO 7405 and ISO 10993-1 - are recommended for assessing biological risks
What does the oSIST prEN ISO 7551:2026 document contain?
oSIST prEN ISO 7551:2026 contains tables for nominal sizes, tip diameters, taper combinations, and colour coding, so users can identify point sizes without reading the full dimensional logic each time. It also includes a table for mandatory and optional package and IFU information, which is useful for label design and audit checks.
The test section gives step-by-step methods for visual examination, length measurement, taper and nominal size calculation, absorption testing, and disintegration testing. The document also includes Figure 1 for the geometry of standard and greater taper points and Figure 2 for disintegration acceptance criteria.
For testing and quality control, the document gives the sampling plan, conditioning requirements, apparatus, and result interpretation rules. For product release and regulatory review, it gives the information that must appear on the outer packaging and in the instructions for use.
Relations
- Effective Date
- 15-Oct-2025
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Frequently Asked Questions
oSIST prEN ISO 7551:2026 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Endodontic absorbent points (ISO/DIS 7551:2026)". This standard covers: This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points. Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations can be made. Reference is made to internationally accepted pharmacopoeia. NOTE 2 National requirements can apply. Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.
This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points. Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations can be made. Reference is made to internationally accepted pharmacopoeia. NOTE 2 National requirements can apply. Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.
oSIST prEN ISO 7551:2026 is classified under the following ICS (International Classification for Standards) categories: 11.060.10 - Dental materials. The ICS classification helps identify the subject area and facilitates finding related standards.
oSIST prEN ISO 7551:2026 has the following relationships with other standards: It is inter standard links to SIST EN ISO 7551:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
oSIST prEN ISO 7551:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2026
Zobozdravstvo - Endodontska vpojna sredstva (ISO/DIS 7551:2026)
Dentistry - Endodontic absorbent points (ISO/DIS 7551:2026)
Zahnheilkunde - Endodontische absorbierende Spitzen (ISO/DIS 7551:2026)
Médecine bucco-dentaire - Cônes absorbants utilisés en endodontie (ISO/DIS
7551:2026)
Ta slovenski standard je istoveten z: prEN ISO 7551
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 7551
ISO/TC 106/SC 1
Dentistry — Endodontic absorbent
Secretariat: AFNOR
points
Voting begins on:
Médecine bucco-dentaire — Cônes absorbants utilisés en
2026-06-03
endodontie
Voting terminates on:
ICS: 11.060.10 2026-08-26
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 7551:2026(en)
DRAFT
ISO/DIS 7551:2026(en)
International
Standard
ISO/DIS 7551
ISO/TC 106/SC 1
Dentistry — Endodontic absorbent
Secretariat: AFNOR
points
Voting begins on:
Médecine bucco-dentaire — Cônes absorbants utilisés en
endodontie
Voting terminates on:
ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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BE CONSIDERED IN THE LIGHT OF THEIR
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Published in Switzerland Reference number
ISO/DIS 7551:2026(en)
ii
ISO/DIS 7551:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Appearance .2
4.2 Length .2
4.3 General .2
4.4 Nominal size designation tolerances .3
4.5 Tip .5
4.6 Colour-coding .5
4.7 Taper .6
4.8 Absorption .6
4.9 Disintegration .6
5 Procurement of samples . 6
6 Measurement and test methods . 7
6.1 Test conditions .7
6.2 Visual examination .7
6.2.1 Test Method . . .7
6.2.2 Interpretation of results .7
6.3 Length .7
6.3.1 Apparatus .7
6.3.2 Test Method . . .7
6.3.3 Interpretation of results .7
6.4 Taper and nominal size measurements .7
6.4.1 Apparatus .7
6.4.2 Test Method . . .8
6.4.3 Interpretation of results .9
6.5 Absorption .9
6.5.1 Apparatus .9
6.5.2 Material.9
6.5.3 Test method .9
6.5.4 Interpretation of results .9
6.6 Disintegration .9
6.6.1 Apparatus .9
6.6.2 Material.9
6.6.3 Test method .9
6.6.4 Interpretation of results .10
7 Product information . 10
7.1 Marking .10
7.2 Labelling .10
7.3 Packaging .11
7.4 Instructions for use .11
Bibliography .13
iii
ISO/DIS 7551:2026(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 second edition cancels and replaces the first edition (ISO 7551:1996), which has been technically
revised.
The main changes are as follows:
— the format has been updated;
— absorbent points other than standard taper absorbent points have been added;
— tables have been updated for the dimensions of greater taper absorbent points;
— the sizes of the absorbent points specified in this document have been aligned with the sizes for obturating
points specified in ISO 6877 and for instruments from the ISO 6360 series;
— the nomenclature of “numbering system” has been changed to “nominal size designation” of the tip;
— Figure 2 has been removed.
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.
iv
ISO/DIS 7551:2026(en)
Introduction
The following information should be taken into account when using this document: 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.
v
DRAFT International Standard ISO/DIS 7551:2026(en)
Dentistry — Endodontic absorbent points
1 Scope
This document specifies the requirements and test methods for sterilized absorbent points used in
endodontic procedures.
Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points
which have been sterilized once in a manner approved by the manufacturer. This document specifies
numerical systems and a colour-coding system for designating the sizes of absorbent points.
Clause 7 specifies product information to be provided. A claim by the manufacturer that the contents of the
unopened pack are sterile is the responsibility of the manufacturer (see 7.3). This document does not specify
requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations can be made.
Reference is made to internationally accepted pharmacopoeia.
NOTE 2 National requirements can apply.
Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and
ISO 11737-3.
2 Normative references
There are no normative references in this document.
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 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
absorbent point
elongated preformed cone or cylinder of a material suitable for absorption of liquids from a root canal,
having a rounded, conical or blunt tip, and a neck that is tapered or cylindrical, or a combination of both
Note 1 to entry: The absorbent points may be used to apply a small quantity of a liquid disinfectant into the root canal
for a short period.
3.2
nominal size designation
size of the tip, designated as D, measured in hundredths of a millimetre, indicated as “000”
ISO/DIS 7551:2026(en)
3.3
taper
percentage increase in diameter along the length of the absorbent point (3.1) from the tip
EXAMPLE 02 taper represents a 2 % increase in diameter along the length of the absorbent point.
3.4
standard absorbent point
absorbent point (3.1) having a uniform 02 taper (3.3) over the first 16 mm from the tip
3.5
greater taper absorbent point
absorbent point (3.1) having a uniform taper (3.3) greater than 02 over the first 16 mm from the tip
3.6
variable taper absorbent point
absorbent point (3.1) having a taper (3.3) that varies over the first 16 mm from the tip
3.7
auxiliary absorbent point
absorbent point (3.1) excepting standard absorbent point (3.4), greater taper absorbent point (3.5) and variable
taper absorbent point (3.6), not subject to nominal size designation (3.2) requirements
3.8
tip
distal end of an absorbent point (3.1) that is first inserted into a root canal
3.9
neck
portion of an absorbent point (3.1) for grasping while inserting the distal end in the root canal
3.10
unit pack
smallest pack of absorbent points (3.1) distributed, containing one or more sizes of absorbent points
4 Requirements
4.1 Appearance
An absorbent pointshall be smooth and uniform in appearance throughout its length, free from extraneous
matter and fibres projecting from the absorbent point. Test in accordance with 6.2.
4.2 Length
The overall length shall be not less than 28 mm, unless otherwise stated by the manufacturer. If some other
length is stated, the absorbent point shall not be less than the stated length. Test in accordance with 6.3.
4.3 General
The designation for standard absorbent p
...