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1、BRITISH STANDARD BS EN ISO 13294:1997 Dental handpieces Dental air-motors The European Standard EN ISO 13294:1997 has the status of a British Standard ICS 11.060.20 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:50:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 13294:1997 This Br
2、itish Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 August 1997 BSI 09-1999 ISBN 0 580 27884 0 National foreword This British Standard is the English language version
3、 of EN ISO 13294:1997. It is identical with ISO 13294:1997. The UK participation in its preparation was entrusted to Technical Committee CH/52, Dental instruments, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any e
4、nquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references Atte
5、ntion is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement these international or European publications may be found in the BS
6、I Standards Catalogue under the section entitled “International Standards Correspondence Index”, or using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsib
7、le for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN ISO title page, page 2, the ISO title page, pages ii to iv, pages 1 to
8、 7 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15
9、12:50:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 13294:1997 BSI 09-1999i Contents Page National forewordInside front cover Foreword2 Forewordiii Text of ISO 132941 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:50:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank License
10、d Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:50:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13294 May 1997 ICS 11.060.20 Descriptors: See ISO document English version Dental handpieces Dental air-motors (ISO 13294:1997) Pices main dent
11、aires Moteurs dentaires air (ISO 13294:1997) Zahnrztliche Handstcke Zahnrztliche Luftmotoren (ISO 13294:1997) This European Standard was approved by CEN on 1997-03-28. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European St
12、andard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. The European Standards exist in three official versions (English, French
13、, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denma
14、rk, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B
15、-1050 Brussels 1997 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13294:1997 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:50:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13294:1997 BSI 09-1999 2 Forewor
16、d The text of the International Standard ISO 13294:1997 has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, e
17、ither by publication of an identical text or by endorsement, at the latest by November 1997, and conflicting national standards shall be withdrawn at the latest by November 1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bo
18、und to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 1
19、3294:1997 was approved by CEN as a European Standard without any modification. NOTENormative references to International Standards are listed in Annex ZA (normative). Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:50:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun
20、 sheffieldun, na, Wed Nov 15 12:50:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13294:1997 ii BSI 09-1999 Contents Page Forewordiii 1Scope1 2Normative references1 3Definitions1 4Classification1 5Requirements1 6Sampling3 7Testing3 8Accompanying documentation6 9Marking6 10Packaging6 Annex A (i
21、nformative) Bibliography7 Annex ZA (normative) Normative references to international publications with their relevant European publications7 Table 1 Free-running speed range1 Descriptors: Dentistry, dental equipment, dental instruments, dental handpieces, classification, specifications, tests, instr
22、uctions, instructions for use, marking, packaging. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:50:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13294:1997 BSI 09-1999iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national stand
23、ards bodies (ISO member bodies). The work of preparing International Standards 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 orga
24、nizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are c
25、irculated 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 ISO 13294 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. Annex A of th
26、is International Standard is for information only. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:50:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:50:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13294:1997 BSI 09-1
27、9991 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 manufacturers instructions, marking and packaging. This
28、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 601-1:1988. This International Standard takes priority over IEC 601-1:1988 as specified in the individual clauses of this
29、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 edit
30、ions 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 ISO maintain registers of currently
31、 valid International Standards. ISO 554:1976, Standard atmospheres for conditioning and/or testing Specifications. ISO 1942-3:1989, Dental vocabulary Part 3: Dental instruments. ISO 3696:1987, Water for analytical laboratory use Specification and test methods. ISO 4211:1979, Furniture Assessment of
32、surface resistance to cold liquids. ISO 7494:1996, Dental units. ISO 7785-2:1995, Dental handpieces Straight and geared angle handpieces. ISO 9168:1991, Dental handpieces Hose connectors. ISO 9687:1993, Dental equipment Graphical symbols. ISO 13402:1995, Surgical and dental hand instruments Determin
33、ation of resistance against autoclaving, corrosion and thermal exposure. IEC 601-1:1988, Medical electrical equipment Part 1: General requirements for safety. IEC 651:1979, Sound level meters. 3 Definitions For the purposes of this International Standard, the definitions given in ISO 1942-3 and in I
34、EC 601-1:1988, clause 2, apply. 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 4.2 Mode of operation Dent
35、al 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 601-1:1988, clause 2.2.2 apply. Testing shall be carried out in accordance with the manufacturers instructio
36、ns. 5 Requirements 5.1 General design 5.1.1 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
37、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. 5.1.1.1 Mechanical strength Dental air-motors which are hand-held during normal use shall not present a safety hazard as a result of a free
38、 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 601-1:1988, clause 21.5. Type Free-running speed range r/min 1up to 10 000 2up to 20 000 3up to 40 000 Licensed Copy: sheffiel
39、dun sheffieldun, na, Wed Nov 15 12:50:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 13294:1997 2 BSI 09-1999 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. 5.1.2 C
40、onnection 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 ISO 7494. 5.1.3 Operating controls 5.1.3.1 General Operating controls shall be designed and located to minimiz
41、e accidental activation. Graphical symbols for operating controls and performance shall be in accordance with ISO 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 manu
42、facturer. 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 applicab
43、le, 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
44、, 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 manufacturers instructions, 8.1 i) and 7.1.2. 5.1.5 Sterilizability If it is claimed that the touchable surface of the dental air-
45、motor is capable of withstanding sterilization, it shall be capable of withstanding 250 sterilization cycles under the manufacturers recommended sterilization procedure without signs of deterioration. NOTEThis test is not a test of lifetime. Visual inspection to indicate any signs of deterioration s
46、hall be carried out in accordance with 7.2.1. Testing shall be carried out in accordance with the manufacturers instructions. 5.1.6 Temperatures 5.1.6.1 Excessive temperatures The requirements given in IEC 601-1:1988, clause 42 apply. 5.1.6.2 Temperature rise of housing The difference between ambien
47、t temperature and the temperature of the touchable surface of the housing under no-load running conditions shall not exceed 20 C. 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 b
48、e 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.
49、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 ISO 7785-2. The equipment shall be capable of attaining a water flowrate of at least 50 ml/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 ISO 7785-2. The equipment shall be capable of attaining an
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