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1、BRITISH STANDARD BS EN ISO 9680:1996 Incorporating Amendment No. 1 BS 7748:1994 renumbered Dental operating light The European Standard EN ISO 9680:1996 has the status of a British Standard Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS
2、EN ISO 9680:1996 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 March 1994 BSI 12-1999 The following BSI references relate to the work on this standard
3、: Committee reference HCC/60 Draft for comment 91/50477 DC ISBN 0 580 23046 5 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/60, upon which the following bodies w
4、ere represented: British Dental Association British Dental Trade Association British Medical Association British Society for Restorative Dentistry British Society for the Study of Prosthetic Dentistry Department of Health Ministry of Defence Scottish Health Services Water Byelaws Advisory Service Wa
5、ter Research Centre Amendments issued since publication Amd. No.DateComments 9228October 1996Indicated by a sideline in the margin Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 9680:1996 BSI 12-1999i Contents Page Committees resp
6、onsibleInside front cover National forewordii Foreword2 1Scope3 2Normative references3 3Definitions3 4Classification3 5Requirements and recommendations4 6Sampling8 7Testing8 8Manufacturers instructions11 9Packaging11 10Marking12 Annex ZA (normative) Normative references to international publications
7、 with their relevant European publications13 Figure 1 Illumination pattern5 Figure 2 Part of CIE 1976 CIELUV uniform chromaticity scale diagram5 Figure 3 Device for determination of shadow reduction10 Table 1 Maximum allowable values of continuous leakage currents7 Table 2 Marking on outside of main
8、s-operated dental operating lights12 List of referencesInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 9680:1996 ii BSI 12-1999 National foreword This British Standard has been prepared under the direction of the
9、Health Care Standards Policy Committee. It is identical with ISO 9680:1993 Dental operating light, prepared by Technical Committee 106 Dentistry, of the International Organization for Standardization (ISO) with the active participation of the UK. In 1996 the European Committee for Standardization (C
10、EN) accepted ISO 9680:1993 as European Standard EN ISO 9680:1996. As a consequence of implementing the European Standard this British Standard is renumbered as BS EN ISO 9680:1996 and any reference to BS 7748:1994 should be read as a reference to BS EN ISO 9680:1996. There are no British Standards c
11、orresponding with IEC 598-1:1986, CIE 15.2:1986 and CIE 69:1987 although BS EN 60598-1:1993 is related to IEC 598-1:1992. The technical committee has reviewed the provision of IEC 598-1:1986, CIE 15.2:1986 and CIE 69:1987, to which normative reference is made in the text, and has decided that they a
12、re suitable for use in conjunction with this standard. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal
13、 obligations. Cross-references International StandardCorresponding British Standard ISO 601-1:1988BS 5724 Medical electrical equipment Part 1:1989 General requirements for safety (Identical) ISO 1942-4:1989BS EN 21942-4 Dental vocabulary Part 4:1994a Dental equipment (Identical) ISO 4211:1979BS 5910
14、 Methods of test for surface finishes for furniture Part 1:1980 Assessment of surface resistance to cold liquids (Identical) ISO 9687:1993BS 7665:1993 Specification for graphical symbols for dental equipment (Identical) a In preparation. Summary of pages This document comprises a front cover, an ins
15、ide front cover, pages i and ii, the EN ISO title page, pages 2 to 14, an inside back cover 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. Licensed Copy: sheffiel
16、dun sheffieldun, na, Wed Nov 15 11:25:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9680 February 1996 ICS 11.060.20 Descriptors: See ISO document English version Dental operating light (ISO 9680:1993, including Technical Corrigendum 1:1995) A
17、ppareil dclairage opratoire dentaire (ISO 9680:1993, Rectificatif Technique 1: 1995 inclus) Zahnrtzliche Behandlungsleuchte (ISO 9680:1993, einschlielich Technische Korrektur 1:1995) This European Standard was approved by CEN on 1995-09-11. CEN members are bound to comply with the CEN/CENELEC Intern
18、al Regulations which stipulate the conditions for giving this European Standard 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.
19、 This European Standard exists in three official versions (English, French, 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 ar
20、e the national standards bodies of Austria, Belgium, Denmark, 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 Kom
21、itee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1996 Copyright reserved to CEN members Ref. No. EN ISO 9680:1996 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9680:1996 BSI 12-1999 2 Foreword The text of t
22、he International Standard from ISO/TC 106, Dentistry, of the International Organization for Standardization (ISO) has been taken over as a European Standard by the Technical Committee CEN/TC 55, Dentistry. This European Standard shall be given the status of a national standard, either by publication
23、 of an identical text or by endorsement, at the latest by October 1996, and conflicting national standards shall be withdrawn at the latest by October 1996. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this
24、European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:22 GMT+00:00 2006, Uncontrolled Copy, (
25、c) BSI EN ISO 9680:1996 BSI 12-19993 1 Scope This International Standard applies to dental operating lights, however constructed, used for illuminating the oral cavity. Its specifies requirements and test methods. It also contains specifications on manufacturers instructions, marking and packaging.
26、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
27、 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 valid International Standards. ISO 1942-4:1989, Dental vocabulary Part 4: Dental equipment. ISO 9687:199
28、3, Dental equipment Graphical symbols. IEC 598-1:1986, Luminaires Part 1: General requirements and tests. IEC 601-1:1988, Medical electrical equipment Part 1: General requirements for safety. CIE 15.2:1986, Colorimetry. CIE 69:1987, Methods of characterizing illuminance meters and luminance meters;
29、Performance, characteristics and specifications. 3 Definitions For the purposes of this International Standard, the definitions given in ISO 1942-4 and the following definitions apply. 3.1 luminaire apparatus which distributes, filters or transforms the light transmitted from one or more lamps and w
30、hich includes all parts necessary for supporting, fixing and protecting the lamps, but not the lamps themselves, and where necessary circuit auxiliaries together with the means of connecting them to the supply IEC 598-1:1986 3.2 lamp light source 3.3 dental luminaire luminaire specially designed and
31、/or presented for use in the dental surgery 3.4 dental operating light item of equipment specially designed for use by a dentist for illuminating the oral cavity, consisting of a dental luminaire and one or more lamps 4 Classification 4.1 According to type of protection against electric shock Dental
32、 operating lights are classified as follows: a) Class I equipment Equipment in which protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in such a way that means are provided for the connection of accessible conductive parts to
33、 the protective (earth) conductor in the fixed wiring of the installation in such a way that accessible conductive parts cannot become live in the event of a failure of the basic insulation. b) Class II equipment Equipment in which protection against electric shock does not rely on basic insulation
34、only, but in which additional safety precautions such as double insulation or reinforced insulation are provided, there being no provision for protective earthing or reliance upon installation conditions. 4.2 According to degree of protection against electric shock Dental operating lights are only o
35、f type B equipment. Type B equipment Class I or II equipment, or equipment with an internal electrical power source providing an adequate degree of protection against electric shock particularly regarding: allowable leakage currents; reliability of the protective earth connection (if present). Type
36、B equipment is, for example, suitable for intentional external and internal application to the patient, excluding direct cardiac application. 4.3 According to mode of operation Dental operating lights are a type of equipment with continuous operation. Licensed Copy: sheffieldun sheffieldun, na, Wed
37、Nov 15 11:25:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9680:1996 4 BSI 12-1999 4.4 Marking or identification The classification shall be marked or identified in accordance with 8.2. 5 Requirements and recommendations 5.1 General Dental operating lights shall be designed, constructed and m
38、anufactured so that, when properly transported, stored, installed, used and maintained according to the manufacturers instructions, they cause no danger which could reasonably be foreseen to the patient, to the personnel or to the surroundings in normal use and in single-fault condition. The dental
39、operating light shall have the strength and rigidity necessary to resist the stresses to which it may be subjected in normal dental practice without risk of introducing fire, electric shock or accident hazard. Those dental operating lights which are intended to be permanently fixed on the ceiling, t
40、he wall or the floor shall have provision for this (see 5.3.4.3). Testing shall be carried out in accordance with 7.2. If the equipment also passes all the tests described in this International Standard, it shall be considered that these requirements are fulfilled. In addition, it is recommended tha
41、t edges and corners of components and parts accessible to the patient or personnel should be finished in such a manner as to avoid injury to the patient or personnel. 5.2 Optical 5.2.1 Level of illuminance The level of illuminance shall be adjustable. The adjustment should preferably be continuous b
42、ut, if in steps, it shall be made with at least three levels of illuminance (two approximately equal steps). The adjustment of illumination shall include a range from 8 000 lx to 15 000 lx. Testing shall be carried out in accordance with 7.2 and 7.3.2. 5.2.2 Illumination pattern The area of maximum
43、illuminance shall lie within a circle of 50 mm diameter with no illuminance less than 75 % of the maximum. If the illuminance pattern is larger than the 50 mm diameter circular area, the 50 % of maximum illuminance isolux should be plotted (see Figure 1). Testing shall be carried out in accordance w
44、ith 7.3.2. 5.2.3 Illumination uniformity The illumination shall decrease in intensity progressively and smoothly (with reversal of slope not exceeding 10 % of the centre illumination) toward the pattern edge, within the limits given in 5.2.2. Testing shall be carried out in accordance with 7.3.2. 5.
45、2.4 Illumination in patients eyes The level of illumination 60 mm above a line parallel to a horizontal line through the area of maximum illuminance shall be not greater than 1 200 lx (see Figure 1). Testing shall be carried out in accordance with 7.3.2. 5.2.5 Light points in reflector The reflector
46、 should be free of glare in the patients eyes during normal operation. Testing shall be carried out in accordance with 7.2. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9680:1996 BSI 12-19995 Figure 1 Illumination pattern Figure 2
47、Part of CIE 1976 CIELUV uniform chromaticity scale diagram Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9680:1996 6 BSI 12-1999 5.2.6 Chromatic aberration No colour separation (chromatic aberration) of the light incident upon the s
48、creen shall be visible inside the 50 % of maximum illuminance isolux line. Testing shall be carried out in accordance with 7.3.3. 5.2.7 Correlated colour temperature The light emitted by the dental operating light shall have a correlated colour temperature between 3 600 K and 6 500 K at 15 000 lx at
49、 the origin of the coordinates of the target. The trichromatic coordinates of the four extreme points are given in Figure 2. The manufacturer shall supply the spectrum emission curve of the dental operating light at 15 000 lx together with the black body response curve at the corresponding correlated colour temperature, so that they may be compared. Testing shall be carried out in accordance with 7.3.4. 5.2.8 Radiant heat in pattern The temperature rise shall be at as low a temperature as possible and not greater than 15 K at any po