SIST EN ISO 13294:2000
(Main)Dental handpieces - Dental air-motors (ISO 13294:1997)
Dental handpieces - Dental air-motors (ISO 13294:1997)
Zahnärztliche Handstücke - Zahnärztliche Luftmotoren (ISO 13294:1997)
Diese Internationale Norm legt Anforderungen und Prüfmethoden für zahnärtzliche Luftmotoren, die von zahnärztlichen Behandlungsgeräten aus betrieben werden und zum Antrieb zahnärztlicher gerader und abgewinkelt angetriebener Handstücke, die am Patienten verwendet werden, vorgesehen sind. Sie enthält auch Festlegungen für Herstelleranweisungen, Kennzeichung und Verpackung.
Pieces a main dentaires - Moteurs dentaires a air (ISO 13294:1997)
La présente Norme internationale prescrit les exigences et les méthodes d'essai relatives aux moteurs dentaires à air, actionnés par des units dentaires et utilisés pour les pièces à mains rectilignes et à contre-angles, utilisés pour le traitement sur des patients. Elle contient également des prescriptions relatives aux instructions du fabricant, au marquage et au conditionnement. La présente Norme internationale fait référence, lorsque le cas se présente, à la CEI 601-1:1988, qui est la norme de base relative à la sécurité des appareils électromédicaux, en indiquant les numéros des articles concernés de la CEI 601-1:1988. Comme indiqué dans les différents articles de la présente Norme internationale, les prescriptions de la présente Norme internationale ont priorité sur celles de la CEI 601-1:1988. Seules les prescriptions fixées par la présente Norme internationale sont applicables.
Dental handpieces - Dental air-motors (ISO 13294:1997)
General Information
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dental handpieces - Dental air-motors (ISO 13294:1997)Zahnärztliche Handstücke - Zahnärztliche Luftmotoren (ISO 13294:1997)Pieces a main dentaires - Moteurs dentaires a air (ISO 13294:1997)Dental handpieces - Dental air-motors (ISO 13294:1997)11.060.20Dental equipmentICS:Ta slovenski standard je istoveten z:EN ISO 13294:1997SIST EN ISO 13294:2000en01-januar-2000SIST EN ISO 13294:2000SLOVENSKI
STANDARD
SIST EN ISO 13294:2000
SIST EN ISO 13294:2000
SIST EN ISO 13294:2000
SIST EN ISO 13294:2000
SIST EN ISO 13294:2000
INTERNATIONAL STANDARD First edition 1997-05-01 Dental handpieces - Dental air-motors Pi&es h main dentaires - Moteurs dentaires 2 air Reference number IS0 13294: 1997(E) SIST EN ISO 13294:2000
IS0 13294: 1997(E) Contents 1 Scope . 1 2 Normative references . 1 3 Definitions . 1 4 Classification . 2 5 Requirements . 2 6 Sampling . 5 7 Testing . .~.8~~a~~~‘898.~.~ . 5 8 Accompanying documentation . 9 9 Marking . 10 10 Packaging . 10 Annex A Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 11 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 CH-1211 Geneve 20 l Switzerland Internet central @ iso.ch x.400 c=ch; a=40Onet; p=iso; o=isocs; s=central Printed in Switzerland ii SIST EN ISO 13294:2000
0 IS0 IS0 13294: 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 13294 was prepared by Technical Committee lSO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. Annex A of this International Standard is for information only. SIST EN ISO 13294:2000
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INTERNATIONAL STANDARD 0 IS0 IS0 13294: 1997(E) Dental handpieces - Dental air-motors 1 Scope This International Standard specifies requirements and test methods for dental air-motors, operated by dental units, and used for straight and geared angle handpieces for application on patients. It also contains specifications on manufacturer’s instructions, marking and packaging. This International Standard refers to IEC 601-1:1988, the basic standard on safety of medical electrical equipment, wherever relevant, by stating the respective clause numbers of IEC 601-I :I 988. This International Standard takes priority over IEC 601-l :I988 as specified in the individual clauses of this International Standard. Only the specifications laid down in this International Standard are applicable. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard 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, IS0 l942-3:1989, IS0 3696: 1987, IS0 4211 :I 979, IS0 7494:1996, IS0 77852:1995, IS0 9168:1991, IS0 9687: 1993, IS0 13402: 1995, IEC 60101:1988, IEC 651:1979, 3 Definitions Standard atmospheres for conditioning and/or testing - Specifications. Dental vocabulary - Part 3: Dental instruments. Water for analytical laboratory use - Specification and test methods. Furniture - Assessment of surface resistance to cold liquids. Dental units. Dental handpieces - Straight and geared angle handpieces. Dental handpieces - Hose connectors. Dental equipment - Graphical symbols. Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure. Medical electrical equipment - Part I: General requirements for safety. Sound level meters. For the purposes of this International Standard, the definitions given in IS0 1942-3 and in IEC 601-I :I 988, clause 2, apply l SIST EN ISO 13294:2000
IS0 13294: 1997(E) 0 IS0 4 Classification 4.1 Speed range Dental air-motors are classified according to the free-running speed range of the dental air motor without a dental handpiece or with a dental handpiece as described in 5.2.7. Table 1 - Free-running speed range Type Free-running speed range r/min 1 upto 2 up to 20 000 r I ~~~ 3 up to 40 000 I 4.2 Mode of operation Dental air-motors are a type of equipment which is usually operated intermittently. Testing shall be carried out in accordance with 8.1. 4.3 Environmental conditions The requirements given in IEC 601-I :1988, clause 2.2.2 apply. Testing shall be carried out in accordance with the manufacturer’s instructions. 5 Requirements 5.1 General design 5.1 .l Construction and layout Dental air-motors shall be constructed to 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. These requirements cannot be objectively assessed. They are considered as fullfilled if the tests in 5.1 and 5.2 are passed. 5.1 .l .l Mechanical strength Dental air-motors which are hand-held during normal use shall not present a safety hazard as a result of a free fall from a height of 1 m onto a hard surface, if not otherwise specified by the manufacturer. Testing shall be carried out in accordance with 7.2.1 and, if applicable, IEC 601-l :I 988, clause 21.5. 5.1 .1.2 Outer surfaces, corners and edges Surfaces, corners and edges which may cause injury shall be avoided or covered. Testing shall be carried out in accordance with 7.2.1. 2 SIST EN ISO 13294:2000
0 IS0 IS0 13294: 1997(E) 51.2 Connection and supply Dental air-motors shall be capable of being easily disconnected from and reconnected to the services. The services shall be supplied by a dental unit in accordance with IS0 7494. 5.1.3 Operating controls 5.1.3.1 General Operating controls shall be designed and located to minimize accidental activation. Graphical symbols for operating controls and performance shall be in accordance with IS0 9687. Testing shall be carried out in accordance with 7.2.1. 5.1.3.2 Speed By the use of operating controls, dental air-motors shall be capable of changing speed as specified by the manufacturer. The controls shall be provided at the dental air-motor itself or at the dental unit. Testing shall be carried out in accordance with 7.2.1. 5.1.3.3 Direction of rotation (if applicable) Dental air-motors shall provide operating controls for clockwise and anticlockwise rotation, if applicable, as specified by the manufacturer. The controls shall be provided at the dental air-motor itself or at the dental unit. Testing shall be carried out in accordance with 7.2.1. 5.1.4 Cleaning and disinfection All touchable parts of dental air-motors shall be capable of being cleaned and disinfected, without deterioration of the dental air-motor surface or markings, by using agents recommended by the manufacturer. Testing shall be carried out in accordance with the manufacturer’s instructions, 8.1 i) and 7.1.2. 5.1.5 Sterilizability If it is claimed that the touchable surface of the dental air-motor is capable of withstanding sterilization, it shall be capable of withstanding 250 sterilization cycles under the manufacturer’s recommended sterilization procedure without signs of deterioration. NOTE - This test is not a test of lifetime. Visual inspection to indicate any signs of deterioration shall be carried out in accordance with 7.2.1. Testing shall be carried out in accordance with the manufacturer’s instructions. 5.1.6 Temperatures 5.1.6.1 Excessive temperatures The requirements given in IEC 601-I :I 988, clause 42 apply. 5.1.6.2 Temperature rise of housing The difference between ambient temperature and the temperature of the touchable surface of the housing under no-load running conditions shall not exceed 20 “C. 3 SIST EN ISO 13294:2000
IS0 13294: 1997(E) 0 IS0 Testing shall be carried out in accordance with 7.1.3. 5.1.7 Resistance to corrosion The touchable surface of dental air-motors as specified from the manufacturer shall be corrosion-resistant, i.e. the materials used shall show no visible signs of corrosion after having been subjected to autoclave procedures. Visual inspection to indicate any signs of deterioration shall be carried out in accordance with 7.2.1. Testing shall be carried out in accordance with 7.1.4. 5.2 Technical requirements 5.2.1 Spray water supply Dental air-motors shall be equipped, if applicable, to transmit water to a dental handpiece in accordance with IS0 7785-2. The equipment shall be capable of attaining a water flowrate of at least 50 mI/min at 250 kPa (2,5 bar). Testing shall be carried out in accordance with 7.2.2. 5.2.2 Spray air supply Dental air-motors shall be equipped, if applicable, to transmit air to a dental handpiece in accordance with IS0 7785-2. The equipment shall be capable of attaining an air flowrate of at least I,5 I/min at 250 kPa (2,5 bar). Testing shall be carried out in accordance with 7.2.3. 5.2.3 Motor air supply Dental air-motors shall be operated by a pressure air supply in accordance with the manufacturer’s instructions. The necessary flowrate should be G 65 l/min in a pressure range of 200 kPa to 400 kPa (2,0 bar to 4,0 bar). If the dental air-motor has a connection of type B, C or D in accordance with IS0 9168, it shall have an exhaust air connection. Testing shall be carried out in accordance with 7.2.4. 5.2.4 Handpiece connector The configuration, dimensions and tolerances of the dental air-motor to be connected to a dental handpiece should comply with IS0
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