SIST EN ISO 7785-1:2000
(Main)Dental handpieces - Part 1: High-speed air turbine handpieces (ISO 7785-1:1997)
Dental handpieces - Part 1: High-speed air turbine handpieces (ISO 7785-1:1997)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Revision of EN 27785-1:1994.
Zahnärztliche Handstücke - Teil 1: Schnellaufende luftbetriebene Turbinen-Handstücke (ISO 7785-1:1997)
Dieser Teil der ISO 7785 legt die Anforderungen und Prüfmethoden für die Anwendung von schnell-laufenden luftbetriebenen Turbinen-Handstücken (weiterhin als Handstücke bezeichnet) an Patienten fest. Er beinhaltet auch Anforderungen an Herstelleranweisungen, Verpackung und Markierung. Dieser Teil der ISO 7785 ist nicht anwendbar auf Einweg - zahnärztliche Handstücke.
Pieces a main dentaires - Partie 1: Pieces a main a turbines a air comprimé pour grandes vitesses (ISO 7785-1:1997)
La présente partie de l'ISO 7785 prescrit les exigences et les méthodes d'essai relatives aux pièces à main à turbines à air comprimé pour grandes vitesses (appelées par la suite pièces à main), utilisées pour les soins dentaires sur des patients. Elle contient également des prescriptions afférentes aux instructions du fabricant, à l'emballage et au marquage. La présente partie de l'ISO 7785 n'est pas applicable aux pièces à main dentaires à usage unique.
Dental handpieces - Part 1: High-speed air turbine handpieces (ISO 7785-1:1997)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7785-1:2000
01-januar-2000
Dental handpieces - Part 1: High-speed air turbine handpieces (ISO 7785-1:1997)
Dental handpieces - Part 1: High-speed air turbine handpieces (ISO 7785-1:1997)
Zahnärztliche Handstücke - Teil 1: Schnellaufende luftbetriebene Turbinen-Handstücke
(ISO 7785-1:1997)
Pieces a main dentaires - Partie 1: Pieces a main a turbines a air comprimé pour
grandes vitesses (ISO 7785-1:1997)
Ta slovenski standard je istoveten z: EN ISO 7785-1:1999
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 7785-1:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7785-1:2000
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SIST EN ISO 7785-1:2000
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SIST EN ISO 7785-1:2000
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SIST EN ISO 7785-1:2000
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SIST EN ISO 7785-1:2000
INTERNATIONAL
IS0
STANDARD
77851
Second edition
1997-08-o 1
Dental handpieces -
Part 1:
High-speed air turb
ne handpieces
Pikes & main dentaires -
Partie I: Pi&es ii main & turbh
es & air cornprim pour grandes vitesses
Reference number
IS0 7785-l :I 997(E)
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SIST EN ISO 7785-1:2000
IS0 7785-l : 1997(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0
member bodies). The work of preparing International Standards is normally carried out through IS0 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. IS0 collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
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.
International Standard IS0 7785-l was prepared by Technical Committee ISOmC 106, Dentistry, Subcommittee
SC 4, Dental instruments.
This second edition cancels and replaces the first edition (IS0 77851:1992), which has been technically revised.
IS0 7785 consists of the following parts, under the general title Dental handpieces.
- Part 7: High-speed air turbine handpieces
- Par? 2: Straight and geared angle handpieces
0 IS0 1997
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l Ct-l-1211 Geneve 20 l Switzerland
Internet central @ iso.ch
x.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
ii
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SIST EN ISO 7785-1:2000
0 IS0
IS0 77854 :I 997(E)
Introduction
This part of IS0 7785 takes priority over IEC 601~I:1988 as specified in the individual clauses of this part of
IS0 7785.
Only the specifications laid down in this part of IS0 7785 are applicable.
This part of IS0 7785 refers to IEC 601-I :1988, the basic standard on safety of medical electrical equipment
wherever relevant, by stating the respective clause numbers of IEC 601-I :I 988.
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SIST EN ISO 7785-1:2000
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SIST EN ISO 7785-1:2000
INTERNATIONAL STANDARD o IS0 IS0 7785-l :1997(E)
Dental handpieces -
Part 1:
High-speed air turbine handpieces
1 Scope
This part of IS0 7785 specifies requirements and test methods for the application of high-speed air
turbine dental handpieces (hereafter termed handpieces) to patients. It also contains specifications on
manufacturer’s instructions, packaging and marking.
This part of IS0 7785 is not applicable to single-use dental handpieces.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions
of this part of IS0 7785. At the time of publication, the editions indicated were valid. All standards are
subject to revision, and parties to agreements based on this part of IS0 7785 are encouraged to
investigate the possibility of applying the most recent editions of the standards indicated below.
Members of IEC and IS0 maintain registers of currently valid International Standards.
IS0 554:1976, Standard atmospheres for conditioning and/or testing - Specifications.
IS0 1797-I :1992, Dental rotary instruments - Shanks - Part 1: Shanks made of metals.
IS0 1942-3: 1989, Dental vocabulary - Part 3: Dental instruments.
IS0 3696:1987, Water for analytical laboratory use - Specification and test methods.
IS0 6507-2: 1983, Metallic materials - Hardness test - Vickers test -
Part 2: HV 0,2 to less than HV 5.
IS0 9168:1991, Dental handpieces - Hose connectors.
IS0 9687: 1993, Dental equipment - Graphical symbols.
Surgical and dental hand instruments - Determination of resistance against
IS0 13402: 1995,
autoclaving, corrosion and thermal exposure.
IEC 651 :I 979, Sound level meters.
Medical electrical equipment - Part 1: General requirements for safety.
IEC 601-I :I 988,
3 Definitions
For the purposes of this part of IS0 7785, the definitions given in IS0 1942-3 apply.
4 Classification
High-speed air turbine handpieces are dental handpieces with a minimum free-running speed of
160 000 min-1 (r/min).
Dental handpieces are classified according to their gear ratio (see table 1).
High-speed air turbine handpieces are usually type 2 handpieces.
Table 1 - Gear ratio
Gear ratio
Type
2
I
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SIST EN ISO 7785-1:2000
0 IS0
IS0 7785-l :1997(E)
5
Requirements
51 . General design
5.1 .I General
The handpiece should be comfortable for the operator to use and easy to manipulate. The outside
surface should be easy to clean and particular attention should be given to providing secure gripping
surfaces for operator manipulation.
Compliance with these requirements cannot be objectively assessed.
If in addition the requirements of 5.1.2, 5.1.3 and 5.2 to 5.10 are complied with, the requirements of
5.1 .l are considered to be fulfilled.
Testing shall be carried out in accordance with 7.1.
5.1.2 Materials
All materials used in the construction of the handpieces should be suitable for their intended use and
should be resistant to cleaning, disinfecting and sterilizing procedures recommended by the
manufacturer.
Compliance with these requirements cannot be objectively assessed.
If in addition the requirements of 5.1.1, 5.1.3 and 5.2 to 5.10 are complied with, the requirements of
5.1.2 are considered to be fulfilled.
Testing shall be carried out in accordance with 7.1.
5.13 Construction and layout
The construction of the handpiece should provide for safe and reliable operation and, if
field-repairable, should be capable of being easily disassembled and reassembled for maintenance
and repair, using readily available tools or those supplied by the manufacturer.
Compliance with these requirements cannot be objectively assessed.
If in addition the requirements of 5.1.1, 5.1.2 and 5.2 to 5.10 are complied with, the requirements of
5.1.3 are considered to be fulfilled.
Testing shall be carried out in accordance with 7.1.
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SIST EN ISO 7785-1:2000
IS0 7785-l :1997(E)
0 IS0
5.1.4 Head dimensions and nomenclature
If the manufacturer includes the head dimensions in the operator’s manual (see note in clause 8) they
shall be the dimensions as shown in figure 1 and shall be expressed to an accuracy of f: (),I mm on
lengths and =t 1 O on angles using the nomenclature of figure 1.
Testing shall be carried out in accordance with 7.2.
D Maximum diameter
max
1
Maximum length of non-rotating component
max
a
Visibility angle
Projection using 19 mm test mandrel
I,
- Terminology for measuring head dimensions
Figure 1
52 . Chuck
5.2.1 General
instruments the shanks of which comply with IS0
The chuck shall be capable of accepting rotary
1797-l.
52.2 Test mandrel
in figure 2.
The test mandrel shall have the dimensions shown
Dimensions in millimetres
Surface roughness values in micrometres
Roundedends
Ra 0,X
(both ends)
7
Ra O,lS/
o~~~~~o,s~o,,
, - a
I
19 2 0,l
c
Figure 2 - Test mandrel
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SIST EN ISO 7785-1:2000
0 IS0
IS0 7785-l : 1997(E)
5.2.3 Spring-type chuck, friction grip
The force to insert into, or to withdraw the test mandrel from, the spring-type chuck shall be between
22 N and 45 N.
Testing shall be carried out in accordance with 7.3.1.
When locked in the chuck, the test mandrel shall transmit a torque of at least I,6 Ncm without
slipping.
Testing shall be carried out in accordance with 7.3.2.
5.2.4 Mechanical locking chuck
The force to extract the test mandrel from the mechanical locking chuck shall be at least 22 N.
Testing shall be carried out in accordance with 7.3.1.
When locked in the chuck, the test mandrel shall transmit a torque of at least 1,6 Ncm without
slipping.
Testing shall be carried out in accordance with 7.3.2.
The locking or unlocking force required to position the rotary instrument in the chuck should be the
minimum force sufficient to prevent accidental unlocking in use.
5.2.5 Push-button locking chucks and other systems
The force to extract the test mandrel from the chuck system shall be at least 22 N.
Testing shall be carried out in accordance with 7.3.1.
When locked in the chuck, the test mandrel shall transmit a torque of at least I,6 Ncm without
slipping.
Testing shall be carried out in accordance with 7.3.2.
5.2.6 Eccentricity
The eccentricity of the test mandrel in rotation and without applied load shall not exceed a total
indicated run-out of 0,03 mm.
Testing shall be carried out in accordance with 7.3.3.
53 . Performance
5.3.1 Speed
The rotational speed of the test mandrel shall be at least the minimum free-running speed stated by
the manufacturer in the operator’s manual, with a minimum of 160 000 min-’ (Vmin).
Testing shall be carried out in accordance with 7.4.
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SIST EN ISO 7785-1:2000
0 IS0
IS0 77851:1997( E)
5.3.2 Stall torque
The stall torque shall be at least 0,05 Ncm.
Testing shall be carried out in accordance with 7.5.
54 . Water and spray air supply
5.4.1 General
The handpiece shall provide cooling capability at the operating area.
Testing shall be carried out in accordance with 7.1 and 7.6.
5.4.2 Water cooling
The handpiece shall provide water coolant capability at the operating area of the rotary instrument. The
handpiece shall have a capability of attaining a water flowrate of at least 50 ml/min at 200 kPa (2,O
bar) .
Testing shall be carried out in accordance with 7.6.2.1.
5.4.3 Air cooling
Air coolant capability may be provided at the discretion of the manufacturer. Handpieces having air
coolant capability shall direct air to the operating area of the rotary instrument. If water and air are used
simultaneously, a cooling mist shall be created and transmitted to the cutting area of the rotary
instrument. The handpiece shall be capable of attaining an air flowrate of at least I,5
...
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