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 - Endodontische 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
SIST EN ISO 7551:2023
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
SIST EN ISO 7551:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 7551:2023
---------------------- Page: 2 ----------------------
SIST EN ISO 7551:2023
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 7551:2023
EN ISO 7551:2023 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 7551:2023
EN ISO 7551:2023 (E)
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.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 7551:2023
---------------------- Page: 6 ----------------------
SIST EN ISO 7551:2023
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 2023
---------------------- Page: 7 ----------------------
SIST EN ISO 7551:2023
ISO 7551:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© IS
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.