THAI INDUSTRIAL STANDARD - thaiplastics.org · This part of ISO 7785 takes priority over lEG 601-1:1988 as specified in the individual clauses of this part of ISO 7785. Only the specifications

THAI INDUSTRIAL STANDARD

,118ft.1981 n1111- 2543

ISO 7785- 1 : 1997

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DENTALHANDPffiCES-

PART I : HIGH - SPEED AIR TURBINE HANDPIECES

ICS 11.060.20 ISBN 974-608-414-3

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2Jt)fl. 1981 it1t1 1-2543

ISO 7785-1 : 1997

Introduction

This part of ISO 7785 takes priority over lEG 601-1:1988 as specified in the individual clauses of this part ofISO 7785.

Only the specifications laid down in this part of ISO 7785 are applicable.

This part of ISO 7785 refers to lEG 601-1:1988, the basic standard on safety of medical electrical equipmentwherever relevant. by stating the respective clause numbers of lEG 601-1:1988.

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mm. 1981 I"'" 1-2543

ISO 7785-1 : 1997

Dental handpieces -

Part 1:

High-speed air turbine handpieces

1 ScopeThis part of ISO 7785 specifies requirements and test methods for the application of high-speed airturbine dental handpieces (hereafter termed handpieces) to patients. It also contains specifications onmanufacturer's instructions, packaging and marking.

This part of ISO 7785 is not applicable to single-use dental handpieces.

2 Normative referencesThe following standards contain provisions which, through reference in this text, constitute provisionsof this part of ISO 7785. At the time of publication, the editions indicated were valid. All standards aresubject to revision, and parties to agreements based on this part of ISO 7785 are encouraged toinvestigate the possibility of applying the most recent editions of the standards indicated below.Members of lEG and ISO maintain registers of currently valid Intemational Standards.

3 Definitions

Standard atmospheres for conditioning and/or testing - Specifications.Dental rotary instruments - Shanks - Part 1: Shanks made of metals.Dental vocabulary - Part 3: Dental instruments.Water for analytical laboratory use - Specification and test methods.Metallic materials - Hardness test - Vickers test -Part 2: HV 0,2 to less than HV 5.Dental handpieces - Hose connectors.Dental equipment - Graphical symbols.Surgical and dental hand instruments - Determination of resistance againstautoclaving, corrosion and thermal exposure.Sound level meters.

Medical electrical equipment - Part 1: General requirements for safety.

For the purposes of this part of ISO 7785, the definitions given in ISO 1942-3 apply.

4 ClassificationHigh-speed air turbine handpieces are dental handpieces with a minimum free-running speed of160000 min-1 (r/min).

Dental hand pieces are classified according to their gear ratio (see table 1).

High-speed air turbine handpieces are usually type 2 handpieces.

Table 1 - Gear ratio

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ISO 554:1976,ISO 1797-1 :1992,ISO 1942-3:1989,ISO 3696:1987,ISO 6507-2:1983,

ISO 9168:1991,ISO 9687: 1993,ISO 13402:1995,

lEG 651:1979,lEG 601-1:1988,

Type Gear ratio

1 1 : < 1

2 1 : 1

3 1 : > 1

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.mm. 1981 ItUJ 1-2543

ISO 7785-1 : 1997

5 Requirements5.1 General design

5.1.1 General

The handpiece should be comfortable for the operator to use and easy to manipulate. The outsidesurface should be easy to clean and particular attention should be given to providing secure grippingsurfaces 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 of5.1.1 are considered to be fulfilled.

Testing shall be carried out in accordance with 7.1.

5.1.2 MaterialsAll materials used in the construction of the handpieces should be suitable for their intended use andshould be resistant to cleaning, disinfecting and sterilizing procedures recommended by themanufacturer.


If in addition the requirements of 5.1.1, 5.1.3 and 5.2 to 5.10 are complied with, the requirements of5.1.2 are considered to be fulfilled.

Testing shall be carried out in accordancewith 7.1.

5.1.3 Construction and layoutThe construction of the handpiece should provide for safe and reliable operation and, iffield-repairable, should be capable of being easily disassembled and reassembled for maintenanceand repair, using readily available tools or those supplied by the manufacturer.


If in addition the requirements of 5.1.1, 5.1.2 and 5.2 to 5.10 are complied with, the requirements of5.1.3 are considered to be fulfilled.


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ISO 7785-1 : 1997

5.1.4 Head dimensions and nomenclature

If the manufacturer includes the head dimensions in the operator's manual (see note in clause 8) theyshall be the dimensions as shown in figure 1 and shall be expressed to an accuracy of :t 0.1 mm onlengths and :t 10 on angles using the nomenclature of figure 1.


Dmax

lmax

Maximum diameter

Maximum length of non-rotating component

Visibility angle

Projection using 19 mm test mandrel

Figure 1 - Terminology for measuring head dimensions

5.2 Chuck

5.2.1 General

The chuck shall be capableof acceptingrotary instrumentsthe shanksof which comply with ISO1797-1.

5.2.2 Test mandrel

The test mandrel shall have the dimensions shown in figure 2.

Dimensions in millimetres

Surface roughness values in micrometres

No~

00I

~~

Rounded ends(both ends)

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e 0,5 ~ 0,1 0,5 ~ 0.1

19 ~ 0.1

Figure 2 -Test mandrel

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,2.180.1981 1a2J 1-2543

ISO 7785-1 : 1997

5.2.3 Spring-type chuck, friction gripThe force to insert into, or to withdraw the test mandrel from, the spring-type chuck shall be between22 Nand 45 N.

Testing shall be carried out in accordancewith 7.3.1.

When locked in the chuck, the test mandrel shall transmit a torque of at least 1,6 N'cm withoutslipping.


5.2.4 Mechanical locking chuckThe force to extract the test mandrel from the mechanical locking chuck shall be at least 22 N.




The locking or unlocking force required to position the rotary instrument in the chuck should be theminimum 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 7.3.2.

5.2.6 EccentricityThe eccentricity of the test mandrel in rotation and without applied load shall not exceed a totalindicated run-out of 0,03 mm.


5.3 Performance

5.3.1 SpeedThe rotational speed of the test mandrel shall be at least the minimum free-running speed stated bythe manufacturer in the operator's manual, with a minimum of 160 000 min-1(r/min).


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ISO 7785-1 : 1997

5.3.2 Stall torqueThe stall torque shall be at least 0,05 N.cm.


5.4 Water and spray air supply

5.4.1 GeneralThe handpiece shall provide cooling capability at the operating area.

Testing shall be carried out in accordancewith 7.1 and 7.6.

5.4.2 Water coolingThe handpiece shall provide water coolant capability at the operating area of the rotary instrument. Thehandpiece shall have a capability of attaining a water flowrate of at least 50 ml/min at 200 kPa (2,0bar).

Testing shall be carried out in accordance with 7.6.2.1.

5.4.3 Air coolingAir coolant capability may be provided at the discretion of the manufacturer. Handpieces having aircoolant capability shall direct air to the operating area of the rotary instrument. If water and air are usedsimultaneously, a cooling mist shall be created and transmitted to the cutting area of the rotaryinstrument. The handpiece shall be capable of attaining an air flowrate of at least 1,5 Vminat 200 kPa(2,0 bar).

Testing shall be carried out in accordancewith 7.6.2.2.

5.5 Handpiece connector

The configuration, dimensions and tolerances of connections for drive air, exhaust air, spray air,cooling water and fibre optic light, as appropriate, shall be in accordancewith ISO 9168.

Testing shall be carried out by inspection and measurement in accordancewith 7.1.

5.6 Air pressureHandpieces shall remain intact. Le. it shall not rupture or burst, when subjected to an air pressure 50 %above the recommendedoperating pressure.


5.7 Noise level

The A-weighted sound pressure value generated by the handpiece shall not exceed 80 dB.

NOTE - It is recommended to reduce the noise level to 65 dB.


5.8 Resistance to corrosion

Handpieces shall be corrosion-resistant, Le. the construction materials shall show no visible signs ofcorrosion after having been subjected to the autoclave procedure specified in 7.8.

Visual inspection shall be carried out in accordancewith 7.1.

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U0f). 19811t'1U 1-2543

ISO 7785-1 : 1997

5.9 Resistance to sterilizing procedureHandpieces shall be capable of being subjected to a minimum of 250 cycles of the manufacturer'srecommended sterilizingprocedure withoutsigns of deterioration.

If a part of handpieces, totally or partiallynonreparable, are of single-use type, the disposable part shallbe sold sterile or shall be sterilizeable once before use, according to the manufacturers instructions.

Testing shall be carried out in accordance with the manufacturer's instructions.

Visual inspection to indicate any signs of deterioration shall be carried out in accordance with 7.1.

5.10 Energy for light supply (if applicable)

The voltage shall not exceed a nominal value of 25 V a.c or 60 V d.c. at rated supply voltage on thetransformer or converter, between conductors in an earth-free circuitwhich is isolated from the supplymains by a safety transformer or by a device withan equivalent separation.


6 SamplingAt least one handpiece for each model series shall be evaluated for compliance with this part of ISO7785.

7 Test methodsAll tests described are type tests.

7.1 Visual inspection

Carry out visual inspection at normal visual acuity without magnification.

7.2 Head dimensions

7.2.1 Apparatus

a) Measuring device such as gauge, dial indicator,etc. withan accuracy of :i: 0,01 mm forlinear dimension and :i:1 0 for angles;

b) Test mandrel as shown in figure2. The test mandrel shall be straight to within0,0025 mmand shall have a hardness of at least 610 HV 5.

Testing of hardness shall be carried out in accordance with ISO 6507-2.

7.2.2 Procedure

Fully insert the test mandrel in the chuck. Measure and record the dimensions shown in figure 1.

7.3 Chuck

7.3.1 Insertion and extraction forces

7.3.1.1 Apparatus

a) Spring force gauge with an accuracy of :t 0,5 N, to measure the insertion and extractionforces.

b) Test mandrel, as shown in figure 2.

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mm. 1981 la1J 1-2543

ISO 7785-1 : 1997

7.3.1.2 Procedure

Install the test mandrel in the handpiece in accordance with the manufacturer's instructions. Operatethe handpiece at the recommended maximum speed for at least 10 s and brake the test mandrelthrough a radial force so that the speed is reduced by at least 50 %. Adjust the force gauge to registerthe maximum force exerted. The force either to insert or to extract the test mandrel shall be increasedgradually until movement of the test mandrel occurs. Record the maximum force required either toinsert or to extract the test mandrel.

'1.3.2 Torque test

Apply the torque stated in 5.2.3, 5.2.4 or 5.2.5, at which the mandrel shall not slip in the chuck.

7.3.3 Eccentricity

7.3.3.1 Apparatus

a) Non-contacting gauging system, e.g. magnetic proximity gauge, with an accuracy of t 10 %of the measured value.

b) Test mandrel, as shown in figure 2, to measurethe dynamic eccentricity.

7.3.3.2 Procedure

Install the test mandrel in the handpiece in accordance with the manufacturer's instructions. Operatethe handpiece with the recommended speed range and without any applied load and record themaximum total indicated run-out at a point on the mandrel 6 mm from the proximal face of the spindle.

7.4 Speed

7.4.1 Apparatus

a) Non-contacting tachometer, e.g. magnetic proximity gauge or photo-optic tachometer orspectrum analyzer with appropriate transducer, accurate to 5 %.

b) Test mandrel, as shown in figure 2.

7.4.2 Procedure

Using the test mandrel, operate the handpiece at the maximum recommended operating pressure.Measure the speed and record the speed in reciprocal minutes (revolutions per minute).

7.5 Stall torque

7.5.1 ApparatusTorque watch or dynamometer, capable of measuring the stall torque in newton-centimetres to anaccuracy of 10 %.

7.5.2 Procedure

Rotate the torque watch slowly and record the maximum value.

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mm. 1981 t"tI 1-2543

ISO 7785-1 : 1997

7.6 Water and spray air supply

7.6.1 Apparatus

a) Volumetric measuring jar, with an accuracy of 5 %, to measure the volume of coolingwater.

b) Flow meter, withan accuracy of 5 %, to measure the spray air fJowrate.

c) Pressure gauge, withan accuracy of 5 %, to measure the air and water supply pressures tothe handpiece inlet.

7.6.2 Procedure

7.6.2.1 Measurement of cooling water flow

Adjust the water supply pressure at the handpiece inlet to 200 kPa (2,0 bar) and operate the handpiecefor 1 min. Record the volume of water collected.

7.6.2.2 Measurement of cooling air flow

Adjust the air supply at the handpiece inletto 200 kPa (2,0 bar). Connect a flowmeter to the handpieceair outlet tube. Record the air flowrate.

7.7 Air pressure

7.7.1 ApparatusPressure gauge capable of measuring the supply pressure to an accuracy of 5 % of the measuredvalue.

7.7.2 Procedure

Operate the handpiece at 50 % above the recommended operating pressure for a period of 10 min andrecord any signs of failure.

7.8 Resistance to corrosion

7.8.1 Apparatus

a) Autoclave, capable of being operated at (136 ~ 2) °C and 220 kPa (2,2 bar).

b) Distilledor deionized water of grade 3 in accordance with ISO 3696.

7.8.2 Procedure

Subject the touchable surface of the handpiece to an autoclave test of 10 cycles at (136 ~ 2) °C.

Testing shall be carried out in accordance with ISO 13402.

7.9 Noise level

7.9.1 Apparatus

a) Precision sound level meter, meeting the requirements for a type 1 instrument as specifiedin IEC651

b) Non-rigid suspension system.

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a.!8f). 1981 Ula.!1-2543

ISO 7785-1 : 1997

7.9.2 Test environmentThe measurements shall be taken in a room with dimensions greater than 2,5 m x 2,5 m x 2,5 m, or ina chamber with a free-field radius of at least 1 m. The background A-weighted noise level shall be lessthan 65 dB. There shall be no hard reflective surface within a 1 m envelope of the handpiece undertest. Foam or non-reflective material may be used to reduce reflections from hard surfaces.

7.9.3 Procedure

Suspend the handpiece in the centre of the chamber by means of a non-rigid suspension system.Operate the handpiece at the maximum recommended pressure. Using the sound level meter,measure the maximum A-weighted sound pressure level value generated from the handpiece at adistance of 0,45 m from the head.

7.10 Energy for light supply (if applicable)

7.10.1 Power supply

The handpiece shall be designed to operate from supply mains as described by the manufacturer.

The requirements given in IEC 601-1:1988, clause 19.1 c) apply.

Testing shall be carried out in accordance with clause 8 using readily available measuring instruments.

7.10.2 Continuous leakage currents and patient auxiliary currentsTest the patient leakage current and the patient auxiliary current with the complete light system

a) after the handpiece has been brought to normal operating temperature in accordance with therequirements of IEC 601-1:1988, clause 7;

b) after moisture preconditioning treatment as described in IEC 601-1:1988, clause 4.10 . Themeasurements shall be carried out with equipment located outside the humidity cabinet andshall commence 1 h after equipment has been taken out of this cabinet, and has been placedin an environment with a temperature less than or equal to the temperature of the humiditycabinet. During testing, those measurementswhich do not energize equipment shall be madefirst.

The requirements given in IEC 601-1:1988, clause 19.4 apply.

7.10.3 Dielectricstrength, creepage distances an~ air clearancesApplythe test voltage of 500 V to the insulaticn parts of the complete handpiece system as describedin IEC 601-1:1988, clause 20.2 but without test B-d, during 1 min and according to table V of IEC601-1:1988:

a) immediately after warming up to operating temperature and switching off the equipment and

b) immediately after moisture preconditioning treatment (as described in IEC 601-1:1988,clause 4.10) with the equipment de-energized during the test and kept in the humiditycabinet, and after the first required sterilization procedurewith the equipment de-energized(see IEC 601-1:1988, clause 44.7).

Apply initially not more than half the prescribed voltage, then raise it over a period of 10 s to the fullvalue, and maintain for 1 min.

IEC 601-1:1988, clause 20.4 and clause 57.10 d) apply.

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tl60. 1981 10tl 1-2543

ISO 7785-1 : 1997

8 Instructionsfor use, maintenanceand serviceEach handpiece shall be accompanied by documents containing instructions for operation,. operatormaintenance, lubrication,safety and servicing.

InstructioRS shall include at least the following information:

a) Name and/or trademark and address of manufacturer or distributor;

b) type classification (free-runningmaximum operating speed);

c) minimumfittinglength of shank (see ISO 1797-1);

d) maximum overall length of rotary instrument;

e) recommended operating pressures;

f) coupling identification;

g) air consumption, in litres per minute, at the recommended operating pressures;

h) statement as to whether the tool for changing the handpiece and bur is sterilizeable, and bywhat methods;

i) recommended cleaning and/or. if applicable. disinfectingagent:

j) recommended sterilizing instructions;

k) statement as to whether the handpiece is field-repairable;

I) recommended light-supply, if applicable;

m) statement of regular maintenance required to maintain the handpiece in good workingorderwhen the handpiece is to be subject to repeated steam sterilization,and a statement of thefrequency required for this maintenance.

NOTE - The head dimensions may be included at the discretion of the manufacturer.

Testing of compliance with the requirements shall be carried out in accordance with 7.1.

9 MarkingHandpieces shall be marked as follows:

a) manufacturers name or trademark;

b) serial number;

c) model or type reference;

d) mark to indicate autoclaveability,if applicable;

e) for parts of single-use handpieces, if sold as sterile product, the packaging must specify the"use by"date.

Graphical symbols used for marking shall be in accordance with ISO 9687.

Testing of compliance with the requirements shall be carried out in accordance with 7.1.

10 PackagingHandpieces should be packet for transportation in such a way that no damage can occur duringanticipated transport conditions.

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Documents

THAI INDUSTRIAL STANDARD - thaiplastics.org · This part of ISO 7785 takes priority over lEG 601-1:1988 as specified in the individual clauses of this part of ISO 7785. Only the specifications