ISO-7785-1-1997.pdf
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1、INTERNATIONAL STANDARD IS0 77851 Second edition 1997-08-o 1 Dental handpieces - Part 1: High-speed air turb Pikes a=400net; p=iso; o=isocs; s=central Printed in Switzerland ii -,-,- 0 IS0 IS0 77854 :I 997(E) Introduction This part of IS0 7785 takes priority over IEC 601I:1988 as specified in the ind
2、ividual 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
3、:I 988. This page intentionally left blank 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 t
4、ermed handpieces) to patients. It also contains specifications on manufacturers 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, const
5、itute 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 standard
6、s indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 554:1976, IS0 1797-I :1992, IS0 1942-3: 1989, IS0 3696:1987, IS0 6507-2: 1983, IS0 9168:1991, IS0 9687: 1993, IS0 13402: 1995, IEC 651 :I 979, IEC 601-I :I 988, Standard atmospheres for condi
7、tioning 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 les
8、s than HV 5. Dental handpieces - Hose connectors. Dental equipment - Graphical symbols. Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure. Sound level meters. Medical electrical equipment - Part 1: General requirements for safety.
9、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
10、 table 1). High-speed air turbine handpieces are usually type 2 handpieces. Table 1 - Gear ratio Type Gear ratio I 2 -,-,- IS0 7785-l :1997(E) 0 IS0 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 surfa
11、ce 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
12、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 b
13、y 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 a
14、nd 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 r
15、equirements 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. -,-,- 0 IS0 IS0 7785-l :1997(E) 5.1.4 Head dimensions and nome
16、nclature If the manufacturer includes the head dimensions in the operators 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
17、out in accordance with 7.2. D max Maximum diameter 1 max Maximum length of non-rotating component a Visibility angle I, Projection using 19 mm test mandrel Figure 1 - Terminology for measuring head dimensions 52 . Chuck 5.2.1 General The chuck shall be capable of accepting rotary 1797-l. instruments
18、 the shanks of which comply with IS0 52.2 Test mandrel The test mandrel shall have the dimensions shown in figure 2. Dimensions in millimetres Surface roughness values in micrometres Roundedends (both ends) 7 Ra 0,X Ra O,lS/ oo,so, , - a I 19 2 0,l c Figure 2 - Test mandrel IS0 7785-l : 1997(E) 0 IS
19、0 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
20、 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 s
21、hall 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
22、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 carrie
23、d 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 man
24、drel shall be at least the minimum free-running speed stated by the manufacturer in the operators manual, with a minimum of 160 000 min- (Vmin). Testing shall be carried out in accordance with 7.4. -,-,- 0 IS0 IS0 77851:1997( E) 5.3.2 Stall torque The stall torque shall be at least 0,05 Ncm. Testing
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