EN ISO 7785-2:1997
(Main)Dental handpieces - Part 2: Straight and geared angle handpieces (ISO 7785-2:1995)
Dental handpieces - Part 2: Straight and geared angle handpieces (ISO 7785-2:1995)
Specifies requirements and test methods for straight and geared angle dental hand instruments for application to patients. Contains also specifications on manufacturer's instructions, marking and packaging.
Zahnärztliche Handstücke - Teil 2: Gerade und abgewinkelte angetriebene Handstücke (ISO 7785-2:1995)
Dieser Teil der ISO 7785 legt die Anforderungen und Prüfmethoden für gerade und abgewinkelte angetriebene Handstücke für die Anwendung an Patienten fest. Er beinhaltet auch Anforderungen an die Herstelleranweisungen, Kennzeichnung und Verpackung. Die Handstücke werden von elektrischen oder luftbetriebenen Motoren betrieben.
Pièces à main dentaires - Partie 2: Pièces à main rectilignes et à contre-angles (ISO 7785-2:1995)
La présente partie de l'ISO 7785 fixe les prescriptions et les méthodes d'essai relatives aux pièces à main rectilignes et à contre-angles, utilisées pour les soins dentaires. Elle contient également des spécifications afférentes aux instructions du fabricant, à l'emballage et au marquage. Ces pièces à main sont actionnées par des moteurs électriques ou à air. Outre ces prescriptions, un certain nombre d'autres points relatifs aux matériaux, à la construction et à la conception générale des pièces à main ne peuvent pas faire l'objet de prescriptions ou d'évaluations objectives. Toutefois, si l'ensemble des prescriptions objectivement vérifiables sont satisfaites, on considère que ces différents points sont acceptables.
Dental handpieces - Part 2: Straight and geared angle handpieces (ISO 7785-2:1995)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2000
Dental handpieces - Part 2: Straight and geared angle handpieces (ISO 7785-
2:1995)
Dental handpieces - Part 2: Straight and geared angle handpieces (ISO 7785-2:1995)
Zahnärztliche Handstücke - Teil 2: Gerade und abgewinkelte angetriebene Handstücke
(ISO 7785-2:1995)
Pieces a main dentaires - Partie 2: Pieces a main rectilignes et a contre-angles (ISO
7785-2:1995)
Ta slovenski standard je istoveten z: EN ISO 7785-2:1997
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
INTERNATIONAL Is0
STANDARD 7785-2
Second edition
1995-08-01
Dental handpieces -
Part 2:
Straight and geared angle handpieces
Pi&es 9 main dentaires -
Pat-tie 2: Pikes B main rectilignes et ;j contre-angles
Reference number
IS0 7785-2:1995(E)
IS0 7785-2: 1995(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 lnternationai
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard IS0 7785-Z was prepared by Technical Committee
ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.
This second edition cancels and replaces the first edition
(IS0 7785-2:1991), of which it constitutes a technical revision.
IS0 7785 consists of the following parts, under the general title Dental
handpieces:
- Part 7: High-speed air turbine handpieces
- Part 2: Straight and geared angle handpieces
0 IS0 1995
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 CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii
0 IS0
IS0 7785-2:1995(E)
Introduction
As handpieces are complex constructions, it is not possible to specify all
details even though they are important. Sometimes only general specifi-
cations are possible, and it is the responsibility of the manufacturer to
make the relevant decisions to achieve a safe and reliable product.
This part of IS0 7785 takes priority over IEC 601-I :I 988 as specified in the
individual clauses of this part of IS0 7785.
Only the specifications laid down in this part of IS0 7785 apply.
This part of IS0 7785 refers to IEC 601-I :I 988, 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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INTERNATIONAL STANDARD Q IS0 IS0 7785=2:1995(E)
Dental handpieces -
Part 2:
Straight and geared angle handpieces
IS0 1942-3: 1989, Dental vocabulary - Part 3: Dental
1 Scope
instruments.
This part of IS0 7785 specifies requirements and test
IS0 3696: 1987, Water for analytical laboratory use -
methods for straight and geared angle handpieces for
Specification and test methods.
application to patients. It also contains specifications
on manufacturer’s instructions, marking and packag-
IS0 3964:1982, Dental handpieces - Coupling di-
ing. These handpieces are operated by electrical or
mens/ons.
air-driven motors. In addition to these specified re-
quirements, there are several other aspects of the
IS0 6507-2:1983, Metallic materials - Hardness test
materials, construction and general design of hand-
- Vickers test - Part 2: HV 0,2 to less than H V 5.
pieces which cannot be objectively specified or as-
sessed. They are considered to be complied with if
IS0 7785-l :I 992, Dental handpieces - Part I: High-
the series of objectively verifiable requirements are
speed air-turbine handpieces.
fulfilled.
IS0 9687:1993, Dental equipment - Graphical sym-
bols.
I EC 601-I : 1988, Medical electrical equipment -
2 Normative references
Part 1: General requirements for safety.
The following standards contain provisions which,
I EC 651: 1979, Sound level meters.
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
3 Definitions
to revision, and parties to agreements based on this
For the purposes of this part of IS0 7785, the defi-
part of IS0 7785 are encouraged to investigate the
nitions in IS0 1942-3 apply.
possibility of applying the most recent editions of the
standards indicated below. Members of IEC and IS0
maintain registers of currently valid International
4 Classification
Standards.
Straight and geared angle handpieces are dental
IS0 1797-I :1992, Dental rotary instruments -
handpieces driven by dental low-voltage or dental air
Shanks - Part I: Shanks made of metals.
motors.
Straight and geared angle handpieces are classified
IS0 1797-2:1992, Dental rotary instruments -
as given in table 1 of IS0 7785-l.
Shanks - Part 2: Shanks made of plastics.
IS0 7785-2: 1995(E)
5.1.4 Head and nose dimensions and
5 Requirements
terminology
5.1 General design
If the manufacturer includes the head and nose di-
mensions in the operator’s manual (see 8.2) they shall
5.1.1 General
be the dimensions shown in figure 1 and shall be ex-
pressed to an accuracy of + 0,l mm on lengths and
The handpiece should be comfortable for the operator
+ l O on angles using the terminology of figure 1.
to use and easy to manipulate. The outside surface -
should be easy to clean and particular attention should
Testing shall be carried out in accordance with 7.2.
be given to provide secure gripping surfaces for op-
erator manipulation.
Compliance with these requirements cannot be ob-
5.2 Chuck
jectively assessed.
5.2.1 General
If in addition the requirements of 5.1.2, 5.1.3 and 5.2
to 5.8 are complied with, the requirements of 5.1 .I
The chuck shall be capable of accepting rotary instru-
are considered to be fulfilled.
ments the shanks of which comply with IS0 1797-l
and IS0 1797-2.
Testing shall be carried out in accordance with 7.1.
5.2.2 Test mandrels
5.1.2 Materials
5.2.3 Spring-type chuck, friction grip
All materials used in the construction of the hand-
The force to insert into, or withdraw the test mandrel
pieces should be suitable for their intended use and
type 3 from the spring-type chuck shall be between
should be resistant to cleaning, disinfecting and ster-
22 N and 45 N.
ilizing procedures recommended by the manufacturer.
Testing shall be carried out in accordance with 7.3.1.
Compliance with these requirements cannot be ob-
jectively assessed.
When locked in the chuck, the test mandrel type 3
shall transmit a torque of at least I,6 N=cm without
If in addition the requirements of 5.1 .I, 5.1.3 and 5.2
slipping.
to 5.8 are complied with, the requirements of 5.1.2
are considered to be fulfilled.
Testing shall be carried out in accordance with 7.3.2.
Testing shall be carried out in accordance with 7.1.
5.2.4 Mechanical locking chuck
The force for extracting the test mandrel type 1 and
5.1.3 Construction and layout
type 2 from the mechanical locking chuck shall be at
least 45 N and the force for extracting the test
The construction of the handpiece should provide for
mandrel type 3 shall be at least 22 N.
safe and reliable operation and, if field-repairable,
should be capable of being easily disassembled and Testing shall be carried out in accordance with 7.3.1.
reassembled for maintenance and repair, using readily
When locked in the chuck, the test mandrel type 1
available tools or those supplied by the manufacturer.
and type 2 shall transmit a torque of at least 2 Ncm
Compl iance with th ese requi rements cannot be ob- and the test mandrel type 3 shall transmit a torque
jective ly assessed. of at least I,6 N=cm without slipping.
If in addition the requirements of 5.1 .I, 5.1.2 and 5.2
Testing shall be carried out in accordance with 7.3.2.
to 5.8 are complied with, the requirements of 5.1.3
The locking or unlocking force required to position the
are considered to be fulfilled.
rotary instrument in the chuck should be the minimum
Testing shall be carried out in accordance with 7.1.
force sufficient to prevent accidental unlocking in use.
IS0 7785-2: 1995(E)
Visibility angle
Maximum Length of non-rotating component
i
Visibility angle
\
Project ion with 445 mm
test ma .ndreL
b) Nose of straight handpieces
a) Head of angle handpieces
- Terminology for measuring head and nose dimensions
Figure 1
Testing shall be carried out in accordance with 7.3.2.
5.2.5 Latch-type chuck
The force for extracting the test mandrel type 1 from
5.2.6.2 For test mandrel type 3
the locking chuck system shall be at least 45 N.
The force for extracting the test mandrel type 3 from
Testing shall be carried out in accordance with 7.3.1.
the locking chuck system shall be at least 22 N.
The latch mechanism shall hold the test mandrel
Testing shall be carried out in accordance with 7.3.1.
type 1 without slipping (in rotation and linear move-
ment) when the test mandrel is subjected to a torque When locked in the chuck the test mandrel type 3
of at least 4 N-cm.
shall transmit a torque of at least I,6 Ncm without
slipping.
Testing shall be carried out in accordance with 7.3.2.
Testing shall be carried out in accordance with 7.3.2.
5.2.6 Push-button locking chucks and other
5.2.7 Eccentricity
systems
The eccentricity of the test mandrel in rotation and
For mandrel type 1 and type 2 without applied load shall not exceed a total indicated
5.2.6.1
run-out of 0,08 mm.
The force for extracting the test mandrel type 1 or
Testing shall be carried out in accordance with 7.3.3.
type 2 from the locking chuck system shall be at least
45 N.
5.3 Water and spray air supply
Testing shall be carried out in accordance with 7.3.1.
When locked in the chuck the test mandrel type 1 5.3.1 Water cooling
shall transmit a torque of at least 4 Ncm and the test
If water cooling is provided, the handpiece shall
mandrel type 2 shall transmit a torque of at least
transmit water to the cutting area of the rotary in-
2 N=cm without slipping.
0 IS0
IS0 7785=2:1995(E)
shall not exceed 20 OC compared to the temperature
strument at a rate of at least 50 ml/min at 200 kPa
of the environment.
(2 bar).
Testing shall be carried out in accordance with 7.5.
Testing shall be carried out in accordance with
7.4.2.1.
5.7 Resistance to corrosion
5.3.2 Air cooling
Handpieces shall be corrosion-resistant, i.e. the con-
If air cooling is provided, the handpiece shall transmit struction materials shall show no visible signs of cor-
having been subjected to the autoclave
air to the cutting area of the rotary instrument at a rate rosion after
of at least I,5 I/min at 200 kPa (2 bar). procedure s Ipecified in 7.6.
Testing shall be carried out in accordance with Visual inspection shall be carried out in accordance
7.4.2.2. with 7.1.
5.3.3 Water and air cooling
5.8 Energy for light supply (if applicable)
If water and air are used simultaneously, a cooling
The voltage shall not exceed a nominal value of 25 V
mist shall be created and transmitted to the cutting
a.c. or 60 V d.c. at rated supply voltage on the trans-
area of the rotary instrument.
former or converter, between conductors in a non-
earthed circuit which is isolated from the supply
Testing shall be carried out in accordance with 7.1.
mains by a safety transformer or by a device with an
equivalent separation.
5.4 Handpiece connector
Testing shall be carried out in accordance with 7.7.
The configuration, dimensions and tolerances of the
back end of the handpiece should comply with
6 Sampling
IS0 3964.
At least one handpiece for each model series shall be
Visual inspection shall be carried out in accordance
evaluated for compliance with this part of IS0 7785.
with 7.1.
7 Test methods
5.5 Resistance to sterilizing procedure
All tests described are type tests.
to a
Handpieces shall be capable of being subjected
rec-
minimum of 250 cycles of the manufacturer’s
7.1 Visual inspection
f de-
ommended sterilizing procedure without signs o
terioration.
Carry 0 ut vis ual i nspec tion at normal visual acuity
without magn if icat .ion.
If a part of the handpiece, totally or partially non-
repairable, is of single-use type, the disposable part
7.2 Head dimensions
shall be sold sterile or shall be sterilizable one time
before use, according to the manufacturer’s in-
7.2.1 Equipment
structions.
Testing shall be carried out in accordance with the
7.2.1.1 Measuring device such as gauge, dial indi-
manufacturer’s instructions.
cator, etc. with an accuracy of 0,Ol mm for linear di-
mension and + I” for angles.
Testing to indicate any signs of deterioration shall be
carried out in accordance with 7.1.
7.2.1.2 Test mandrels as shown in figure 2. The
test mandrels shall be straight to within 0,0025 mm
5.6 Temperature rise
and shall have a hardness of not less than 610 HV 5.
maximum temperature rise at the touchable sur- Testin
...
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