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1、Reference number ISO 15606:1999(E) ISO 1999 INTERNATIONAL STANDARD ISO 15606 First edition 1999-12-15 Dental handpieces Air-powered scalers and scaler tips Pices main dentaires Instruments dentaires pour dtartrage, actionns par air comprim, et parties actives de linstrument pour dtartrage Copyright
2、International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:24:08 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15606:1999(E) PDF disclaimer This PDF file may contai
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5、eters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 1999 All rights reserved. Unless otherwis
6、e 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 either ISO at the address below or ISOs member body in the country of the requester. ISO copyright of
7、fice Case postale 56 ? CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 734 10 79 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii ISO 1999 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical S
8、tandards 1/9972545001 Not for Resale, 04/21/2007 02:24:08 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15606:1999(E) ISO 1999 All rights reservediii ContentsPage Foreword.iv Introduction.v 1Scope 1 2Normative references1 3Terms and definitions .1 4Requirements and re
9、commendations .2 5Sampling.5 6Test methods5 7Instructions for use, maintenance and service 8 8Marking.9 9Packaging.9 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:24:08 MDTN
10、o reproduction or networking permitted without license from IHS -,-,- ISO 15606:1999(E) iv ISO 1999 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International St
11、andards 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
12、 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 3. Draft International Standards adopte
13、d 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 International Standard may be the sub
14、ject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 15606 was prepared by Technical Committee ISO/TC 106,Dentistry, Subcommittee SC 4,Dental instruments. Copyright International Organization for Standardization Provided b
15、y IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:24:08 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15606:1999(E) ISO 1999 All rights reservedv Introduction This International Standard takes priority over IEC 6
16、0601-1:1988 as specified in the individual clauses of this International Standard. Only the specifications laid down in this International Standard are applicable. This International Standard refers to IEC 60601-1:1988, the basic standard on safety of medical electrical equipment, wherever relevant,
17、 by stating the respective clause numbers of IEC 60601-1:1988. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:24:08 MDTNo reproduction or networking permitted without license
18、 from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:24:08 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARDISO 15606
19、:1999(E) ISO 1999 All rights reserved1 Dental handpieces Air-powered scalers and scaler tips 1Scope This International Standard specifies requirements and tests methods for dental air-powered scalers and scaler tips, operated by connection to dental units, for use on patients. It also contains speci
20、fications concerning manufacturers instructions, marking and packaging. 2Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions
21、 of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative
22、document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 1942-3,Dental vocabulary Part 3: Dental instruments. ISO 7000,Graphical symbols for use on equipment Index and synopsis. ISO 9168,Dental handpieces Hose connectors. ISO 9687,Dental
23、 equipment Graphical symbols. ISO 13402:1995,Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure. ISO/TR 15223,Medical devices Symbols to be used with medical device labels, labelling and information to be supplied. IEC 60601-1:1988,Me
24、dical electrical equipment Part 1: General requirements for safety. IEC 60651,Sound level meters. 3Terms and definitions For the purposes of this International Standard, the terms and definitions given in ISO 1942-3 and the following apply. 3.1 scaler tip fixed or interchangeable dental instrument u
25、sed in an air-powered scaler and consisting of a shaft and a working part for dental procedures of air scaling Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:24:08 MDTNo repr
26、oduction or networking permitted without license from IHS -,-,- ISO 15606:1999(E) 2 ISO 1999 All rights reserved 4Requirements and recommendations 4.1General design 4.1.1General Dental air-powered scalers should be comfortable for the operator to use and easy to manipulate. The outside surface of th
27、e scaler should be easy to clean, and particular attention should be given to providing secure gripping surfaces for operator manipulation. In order to reduce glare, highly polished surfaces should be avoided. Dental air-powered scalers normally comprise a handpiece into which scaler tips are interc
28、hangeably inserted. Internal parts should be designed in such a way that either penetration of liquids or particles is impossible or the scalers are easy to clean. Compliance with these requirements cannot be objectively assessed. They are considered as fulfilled if all tests specified in clause 6 a
29、re passed. All tests described in this International Standard are type tests. 4.1.2Materials All materials used in the construction of dental air-powered scalers should be suitable for their intended use. When tested in accordance with 6.10, dental air-powered scalers shall be resistant to cleaning,
30、 disinfecting and sterilizing procedures recommended by the manufacturer. Compliance with these requirements cannot be objectively assessed. They are considered as fulfilled if all tests specified in clause 6 are passed. 4.1.3Construction and layout The construction of dental air-powered scalers sho
31、uld provide for their safe and reliable operation. If field- repairable, the scalers should be capable of being easily disassembled and reassembled for maintenance and repair, utilizing either readily available tools or special tools supplied by the manufacturer. Compliance with these requirements c
32、annot be objectively assessed. They are considered as fulfilled if all tests specified in clause 6 are passed. 4.1.4Dimensions If the manufacturer includes the dimensions of the scaler tip in the operators manual, they shall be the dimensions 2 and 3 named in Figure 1 and shall be expressed to an ac
33、curacy of ? 0,2 mm, using the nomenclature of Figure 1. Testing shall be carried out by inspection and measurement in accordance with 6.2. 4.1.5Handpiece connection The configuration, dimensions and tolerances of hose connections shall be in accordance with ISO 9168. Testing shall be carried out by
34、inspection and measurement in accordance with 6.1. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:24:08 MDTNo reproduction or networking permitted without license from IHS -,
35、-,- ISO 15606:1999(E) ISO 1999 All rights reserved3 Key 1Scaler tip 2Offset 3Length Figure 1 Terminology for measuring dimensions 4.2Scaler tip 4.2.1Extraction force When installed in accordance with the manufacturers instructions, scaler tips shall withstand, without displacement, a minimum axial (
36、extraction) force of 20 N. Testing shall be carried out in accordance with 6.3.1. 4.2.2Torque When installed in accordance with the manufacturers instructions, scaler tips shall withstand, without displacement, a minimum torque of 200 N ? mm. Testing shall be carried out in accordance with 6.3.2. 4.
37、2.3Insertion force The insertion force required to fit scaler tips to the handpiece shall not exceed a force of 50 N and/or a torque of 700 N ? mm. Testing shall be carried out in accordance with 6.3.3. 4.3Performance 4.3.1Frequency The frequency of scaler tips shall be between 4 000 Hz and 40 000 H
38、z, when operated at the air flowrate and air pressure specified by the manufacturer. Testing shall be carried out in accordance with 6.4. 4.3.2Amplitude The maximum amplitude of the scaler tip shall not normally exceed 200 m, when operated at the air flowrate and air pressure as recommended by the m
39、anufacturer. If the maximum amplitude of scaler tips exceeds 200 m in any direction, the manufacturers instruction shall include a corresponding warning. Testing shall be carried out in accordance with 6.5. Copyright International Organization for Standardization Provided by IHS under license with I
40、SO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:24:08 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15606:1999(E) 4 ISO 1999 All rights reserved 4.3.3Stall effort With the dental air-powered scaler operating at the manufacturers specifi
41、ed air pressure and flowrate, the force applied to the scaler tip to stall vibration shall not exceed 10 N. Testing shall be carried out in accordance with 6.6. 4.4Water cooling Air-powered scalers shall provide water-cooling capability to the operating area of the scaler tip at a minimum flowrate o
42、f 20 ml/min at 200 kPa (2,0 bar). Testing shall be carried out in accordance with 6.7. 4.5Air pressure Air-powered scalers shall remain intact, i.e. they shall not rupture or burst, when subjected to an air pressure 50 % above the operating pressure specified by the manufacturer. Testing shall be ca
43、rried out in accordance with 6.8. 4.6Noise level The A-weighted sound pressure value generated by air-powered scalers shall not exceed 80 dBA. NOTEIt is recommended to reduce the the A-weighted noise level to 70 dBA. Testing shall be carried out in accordance with 6.9. 4.7Resistance to corrosion Air
44、-powered scalers shall be corrosion-resistant, i.e. the construction materials shall show no visible signs of corrosion after having been subjected to the autoclave procedure specified in 6.10. Visual inspection shall be carried out in accordance with 6.1. 4.8Resistance to sterilization Air-powered
45、scalers shall be capable of being subjected to a minimum of 250 cycles of the manufacturers specified sterilizing procedure without any signs of deterioration or loss of performance. Single-use scalers, or the disposable (non-reusable) parts of scalers, shall be supplied sterile or shall be capable
46、of withstanding two cycles of sterilization in accordance with manufacturers instructions. Visual inspection shall be carried out to detect any signs of deterioration. 4.9Energy for light supply (if applicable) Scalers shall be supplied with voltage which does not exceed a nominal value of 25 V a.c.
47、 or 60 V d.c. at rated supply voltage on the transformer or converter, between conductors in an earth-free circuit which is isolated from the supply main by a safety transformer or by a device with an equivalent separation. Testing shall be carried out in accordance with 6.11. Copyright Internationa
48、l Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:24:08 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15606:1999(E) ISO 1999 All rights reserved5 5Sampling At least one scaler for each model series shall be tested for compliance with this Internatio