SIST EN ISO 7551:2023
(Main)Dentistry - Endodontic absorbent points (ISO 7551:2023)
Dentistry - Endodontic absorbent points (ISO 7551:2023)
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.
Zahnheilkunde - Absorbierende Spitzen (ISO 7551:2023)
Dieses Dokument legt die Anforderungen und Prüfverfahren für sterilisierte absorbierende Stifte fest, die bei endodontischen Verfahren verwendet werden. Absorbierende Stifte sind in steriler oder nicht steriler Form im Handel erhältlich. Die Anforderungen gelten für absorbierende Stifte, die einmal auf eine vom Hersteller genehmigte Weise sterilisiert wurden. Dieses Dokument beschreibt auch ein Nummernsystem und ein Farbkennzeichnungssystem zur Größenbezeichnung von absorbierenden Stiften.
In Abschnitt 7 wird die erforderliche Kennzeichnung und Verpackung, einschließlich der Gebrauchsanweisung, festgelegt. Anforderungen an und Prüverfahren für die Sterilität werden in diesem Dokument nicht festgelegt, und jede Angabe des Herstellers, dass der Inhalt einer ungeöffneten Verpackung steril ist, liegt in der Verantwortung des Herstellers (siehe Tabelle 2).
ANMERKUNG 1 Es kann auf die geltenden nationalen Vorschriften verwiesen werden.
Es wird auf international anerkannte Pharmakopöen verwiesen.
ANMERKUNG 2 Es können nationale Anforderungen gelten.
Normen zu Validierungsverfahren für Sterilisationsverfahren sind außerdem verfügbar: ISO 11137 1, ISO 11137 2 und ISO 11137 3.
Médecine bucco-dentaire - Cônes absorbants utilisés en endodontie (ISO 7551:2023)
Le présent document spécifie les exigences et les méthodes d’essai applicables aux cônes absorbants stérilisés utilisés en endodontie. Les cônes absorbants sont commercialisés stérilisés ou non stérilisés. Les exigences s’appliquent aux cônes absorbants ayant été stérilisés une fois, selon une méthode approuvée par le fabricant. Le présent document spécifie des systèmes numériques et un système de code de couleurs pour la désignation des tailles de cônes absorbants.
L’Article 7 spécifie l’étiquetage et l’emballage nécessaires, y compris les instructions d’utilisation. Toute revendication émanant du fabricant, indiquant que le contenu de l'étui avant ouverture est stérile, n'engage que le fabricant (voir Tableau 2). Le présent document ne fixe pas d’exigences ou de méthodes d’essai relatives à la stérilité.
NOTE 1 Il est possible de se référer aux exigences nationales en vigueur.
Référence est faite à la pharmacopée acceptée internationalement.
NOTE 2 Des exigences nationales peuvent s'appliquer.
Des normes relatives aux méthodes de validation des procédés de stérilisation sont également disponibles: ISO 11137‑1, ISO 11137‑2 et ISO 11137‑3.
Zobozdravstvo - Endodontska vpojna sredstva (ISO 7551:2023)
Ta dokument določa zahteve in preskusne metode za sterilizirana vpojna sredstva, ki se uporabljajo pri endodontskih postopkih. Vpojna sredstva se tržijo sterilizirana ali nesterilizirana. Zahteve veljajo za vpojna sredstva, ki so bila enkrat sterilizirana na način, ki ga je odobril proizvajalec. Ta dokument določa številske sisteme in sistem barvnih oznak za označevanje velikosti vpojnih sredstev.
Točka 7 določa potrebno etiketiranje in embalažo, vključno z navodili za uporabo. Za izjavo proizvajalca, da je vsebina neodprte embalaže sterilna, mora poskrbeti proizvajalec (glej preglednico 2). Ta dokument ne določa zahtev za preskusne metode za sterilnost.
OPOMBA 1: Mogoče je sklicevanje na nacionalne predpise.
Sklicuje se na mednarodno sprejeto farmakopejo.
OPOMBA 2: Veljajo lahko nacionalne zahteve.
Na voljo so tudi standardi o metodah potrjevanja postopkov sterilizacije: ISO 11137-1, ISO 11137-2 in ISO 11137-3.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2023
Zobozdravstvo - Endodontska vpojna sredstva (ISO 7551:2023)
Dentistry - Endodontic absorbent points (ISO 7551:2023)
Zahnheilkunde - Absorbierende Spitzen (ISO 7551:2023)
Médecine bucco-dentaire - Cônes absorbants utilisés en endodontie (ISO 7551:2023)
Ta slovenski standard je istoveten z: EN ISO 7551:2023
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 7551
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2023
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 7551:1998
English Version
Dentistry - Endodontic absorbent points (ISO 7551:2023)
Médecine bucco-dentaire - Cônes absorbants utilisés Zahnheilkunde - Absorbierende Spitzen (ISO
en endodontie (ISO 7551:2023) 7551:2023)
This European Standard was approved by CEN on 3 March 2023.
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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7551:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 7551:2023) 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 November 2023, and conflicting national standards
shall be withdrawn at the latest by November 2023.
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 7551:1998.
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 7551:2023 has been approved by CEN as EN ISO 7551:2023 without any modification.
INTERNATIONAL ISO
STANDARD 7551
Second edition
2023-05
Dentistry — Endodontic absorbent
points
Médecine bucco-dentaire — Cônes absorbants utilisés en endodontie
Reference number
ISO 7551:2023(E)
ISO 7551:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 7551:2023(E)
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 . 3
4.4 Nominal size designation tolerances . 3
4.5 Colour-coding . 5
4.6 Taper . 5
4.7 Absorption . 5
4.8 Disintegration . 5
5 Procurement of samples . 5
6 Measurement and test methods .5
6.1 Test conditions . 5
6.2 Visual examination . 6
6.3 Length . 6
6.3.1 Apparatus . 6
6.3.2 Method . . 6
6.4 Taper and nominal size measurements . 6
6.4.1 Apparatus . 6
6.4.2 Method for standard and greater taper points . 6
6.4.3 Method for variable taper absorbent points . 8
6.5 Absorption . 8
6.5.1 Apparatus . 8
6.5.2 Material. 9
6.5.3 Method . . 9
6.5.4 Interpretation of results . 9
7 Product information . 9
7.1 Marking . 9
7.2 Packaging . 9
7.3 Labelling . 9
Bibliography .12
iii
ISO 7551:2023(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 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;
— Table 2 has been added 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 7551:2023(E)
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
INTERNATIONAL STANDARD ISO 7551:2023(E)
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 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.
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 6360-1, Dentistry — Number coding system for rotary instruments — Part 1: General characteristics
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 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/
ISO 7551:2023(E)
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”
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 point shall 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.
ISO 7551:2023(E)
4.3 General
The designation for standard absorbent point, greater taper absorbent point, and variable taper
absorbent point shall be in the form of a five-digit numerical set, having two parts: 000 XX, where 000
corresponds to the nominal size designation and XX corresponds to the two significant figures of the
taper per cent. For example, a 2 % taper is designated as 02. The nominal size designation shall include
the specified colour or its abbreviation.
4.4 Nominal size designation tolerances
The diameter tolerances of D, d and d for standard absorbent points and greater taper absorbent
3 16
points (see Figure 1) shall be:
— ±0,05 mm for absorbent point of sizes 008 to 060;
— ±0,07 mm for absorbent point of sizes 070 to 140.
For a variable taper absorbent point, two
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