EN ISO 27020:2010
(Main)Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2010)
Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2010)
ISO 27020:2010 is applicable to brackets and tubes for use in fixed orthodontic appliances.
ISO 27020:2010 gives details of methods to compare the functional dimensions of orthodontic brackets and tubes, the test methods by which they can be determined, as well as packaging and labelling information.
Zahnheilkunde - Brackets und Röhrchen für die Kieferorthopädie (ISO 27020:2010)
Diese Internationale Norm gilt für Brackets und Röhrchen, die in festsitzenden kieferorthopädischen Apparaturen verwendet werden.
Diese Internationale Norm enthält Einzelheiten zu Verfahren für den Vergleich der funktionalen Abmessungen von kieferorthopädischen Brackets und Röhrchen, die Prüfverfahren, mit denen sie bestimmt werden können, sowie Angaben zur Verpackung und Kennzeichnung.
In dieser Internationalen Norm werden keine besonderen qualitativen und quantitativen Anforderungen zum Ausschluss biologischer Risiken gestellt, die in ISO 10993 1 und ISO 7405 beschrieben werden.
Médecine bucco-dentaire - Consoles et tubes utilisés en orthodontie (ISO 27020:2010)
L'ISO 27020:2010 s'applique aux consoles et tubes à utiliser sur les appareils orthodontiques fixes.
L'ISO 27020:2010 également des méthodes détaillées permettant de comparer les dimensions fonctionnelles des consoles et tubes orthodontiques, les méthodes d'essai permettant de les déterminer ainsi que des informations de conditionnement et d'étiquetage.
Zobozdravstvo - Nastavki in cevke za uporabo v ortodontiji (ISO 27020:2010)
Ta mednarodni standard velja za nastavke in cevke za uporabo v fiksnih ortodontskih napravah. Ta mednarodni standard podaja podrobnosti metode za primerjavo funkcionalnih dimenzij ortodontskih nastavkov in cevk, preskusne metode, s katerimi se lahko te določijo, in informacije o pakiranju in opremljanju z nalepkami. Ta mednarodni standard ne določa posebnih kvalitativnih in kvantitativnih zahtev za odsotnost bioloških nevarnosti, ki so zajete v ISO 10993-1 in ISO 7405.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2011
Zobozdravstvo - Nastavki in cevke za uporabo v ortodontiji (ISO 27020:2010)
Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2010)
Zahnheilkunde - Brackets und Röhrchen für die Kieferorthopädie (ISO 27020:2010)
Art dentaire - Consoles et tubes utilisés en orthodontie (ISO 27020:2010)
Ta slovenski standard je istoveten z: EN ISO 27020:2010
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 27020
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2010
ICS 11.060.10
English Version
Dentistry - Brackets and tubes for use in orthodontics (ISO
27020:2010)
Médecine bucco-dentaire - Consoles et tubes utilisés en Zahnheilkunde - Brackets und Röhrchen für die
orthodontie (ISO 27020:2010) Kieferorthopädie (ISO 27020:2010)
This European Standard was approved by CEN on 14 December 2010.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 27020:2010: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 27020:2010) 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 June 2011, and conflicting national standards shall be withdrawn at
the latest by June 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 27020:2010 has been approved by CEN as a EN ISO 27020:2010 without any modification.
INTERNATIONAL ISO
STANDARD 27020
First edition
2010-12-15
Dentistry — Brackets and tubes for use in
orthodontics
Médecine bucco-dentaire — Consoles et tubes utilisés en orthodontie
Reference number
ISO 27020:2010(E)
©
ISO 2010
ISO 27020:2010(E)
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ii © ISO 2010 – All rights reserved
ISO 27020:2010(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 27020 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials.
ISO 27020:2010(E)
Introduction
This International Standard has been developed as a result of the difficulty often encountered by clinicians to
make meaningful comparisons between brackets and tubes using the information currently available from
manufacturers and suppliers.
iv © ISO 2010 – All rights reserved
INTERNATIONAL STANDARD ISO 27020:2010(E)
Dentistry — Brackets and tubes for use in orthodontics
1 Scope
This International Standard is applicable to brackets and tubes for use in fixed orthodontic appliances.
This International Standard gives details of methods to compare the functional dimensions of orthodontic
brackets and tubes, the test methods by which they can be determined, as well as packaging and labelling
information.
This International Standard does not specify specific qualitative and quantitative requirements for freedom
from biological hazards; which are covered in ISO 10993-1 and ISO 7405.
2 Normative references
The following referenced documents are indispensable for the application 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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
angle of torque
θ
occlusal-gingival angle formed between the intersection of the line perpendicular to the tangent to the tooth
side surface of the base and the line bisecting the slot in the occlusal-gingival direction, when viewed along
the mesial-distal long-axis of the slot
NOTE If the angle is oriented toward the occlusal (gingival), it is designated as positive (negative).
See Figure 1.
3.2
angulation
α
angle between the line perpendicular to the mesial-distal long-axis of the slot and the central occlusal-gingival
axis of the bracket/tube, when viewed from the buccal/labial
NOTE The angulation is positive (negative) when the gingival part of the central occlusal-gingival axis is inclined
toward the distal (mesial) relative to the line perpendicular to the mesial-distal long-axis of the slot.
See Figure 2.
ISO 27020:2010(E)
3.3
archwire
wire that is formed approximately to the shape of the dental arch
3.4
auxiliary slot
additional opening in the bracket or tube for insertion of auxiliary elements
3.5
auxiliary slot dimensions
diameter/cross-sectional dimensions of the largest wire that passes through an auxiliary slot
3.6
band
structural annular component affixed to the outer circumference of the crown of a tooth and to which a bracket
or tube can be attached
3.7
base
part of the bracket or the tube that is attached to the enamel or band
3.8
descriptor
code to identify the nominal slot height in thousandths of an inch without unit designation, in accordance with
accepted orthodontic practice (e.g. 18 or 22)
3.9
bracket
tube
structural unit attached to a band or base that is capable of retaining an archwire
3.10 in-out
3.10.1
bracket in-out
l
i
distance between the floor of the slot and the tooth side surface of the base along the intersection of the plane
perpendicular to mesial-distal long-axis of the slot in the centre of the bracket slot and the plane bisecting the
slot in the occlusal-gingival direction, when viewed along the mesial-distal long-axis of the slot
See Figure 3 a).
3.10.2
tube in-out
l
i
distance between the floor of the slot and the tooth side surface of the base, at the mesial end of the tube and
in the midplane of the slot in the occlusal-gingival direction; for tubes with a mesial chamfer, the in-out is the
distance at the mesial end of the tube between that part of the floor of the slot in contact with the largest
dimension of an archwire (round wire for a round tube and a rectangular wire for a rectangular tube) able to
pass the entire tube, and the tooth side surface of the base in the midplane of the slot in the occlusal-gingival
direction, when viewed from the gingival
See Figure 3 b).
2 © ISO 2010 – All rights reserved
ISO 27020:2010(E)
3.11
rotational offset
δ
angle between a line parallel to the floor of the slot and the line connecting the points of intersection of the
lines along the mesial and distal end-faces of the slot at the tooth side surface of the base, when viewed from
the occlusal
NOTE When the distal (mesial) part of the floor of the slot is furthest from the tooth it is known as a distal (mesial)
offset.
See Figure 4.
3.12
slot
mesial-distal oriented opening in a bracket or tube primarily to contain an archwire
3.13
slot depth
d
minimum buccal-lingual dimension of a rectangle where the projection of its buccal/labial side is tangent to the
shorter side of the intended slot, when viewed along the mesial-distal axis of the slot
See Figure 5.
3.14
slot height
h
maximum occlusal-gingival dimension of a rectangle that is fully engaged in the slot, when viewed along the
mesial-distal long-axis of the slot
See Figure 5.
3.15
slot length
l
s
smallest mesial-distal dimension of the slot between the mesial and distal ends of the slot
4 Requirements
4.1 Hazardous elements
For the purposes of this International Standard, cadmium, beryllium, lead and nickel are designated to be
hazardous elements and the manufacturer shall state the concentrations as a mass fraction expressed as a
percentage.
4.2 Measurement of dimensions
4.2.1 The following dimensions shall be recorded to the nearest 0,01 mm. When determined in accordance
with Clause 5, the following dimensions of the product shall comply with the ranges stated by the manufacturer:
a) in-out l
i
b) slot depth d
c) slot height h
d) slot length l
s
e) dimensions of each auxiliary slot.
ISO 27020:2010(E)
4.2.2 The following angles shall be recorded to the nearest 1°. When determined according to Clause 5, the
following angles of the product shall comply with the ranges stated by the manufacturer:
a) angle of torque θ
b) angulation α
c) the rotational offset δ
5 Test methods
5.1 Sampling
Six specimens of a single product from one batch shall be procured for each test.
Measurements shall be made on each dimension listed in 4.2 of each sample.
5.2 Dimensions
5.2.1 Apparatus
Measurements shall be taken with callipers, micrometers, optical comparators, or other devices with an
accuracy of 0,005 mm or 0,5°.
5.2.2 Measurement procedures
5.2.2.1 Angle of torque (see Figure 1)
5.2.2.1.1 When viewed from the labial/buccal, perform the following.
a) Construct a line along the mesial-distal long-axis of the slot (X-axis).
b) Construct plane 1 (see A–A in Figure
...
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