STD-BSI BS EN 2470-3-ENGL 2000 MM 1246 044b575 BaT a BRITISH STANDARD BS EN 12470-3:2000 Clinical thermometers — Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device ‘The European Standard EN 12470-3:2000 has the starus of a British Standard Kes 10005 | | rs a we == an | NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW lili” “adi” ST Copyright by the Europeun Committee For Standardization we Mar 13 15:00:10 2007STD-BSI BS EN 22470-3-ENGL 2000 MM VL24bb9 O84bS7b 72b Mm BS EN 12470-3:2000 National foreword ‘This British Standard isthe official English language version of EN 12470-32000. ‘The UK participation in its preparation was entrusted by Technical Committee LBI36, Laboratory glassware and related apparatus, to Subcommittee LBUS63, ‘Thermometers, which has the responsibility to — ald enquirers to understand the text; — present to the responsible European committee any enquiries 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 list of organizations represented on this subcommittee can be obtained on request 1 its secretary. Crose-references ‘The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Comespondence Index’, or by 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 responsible 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, the EN title page, pages 2to 9 and a back cover. ‘The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication ‘Amd No. [Date CommentsSTD-BSI BS EN 22970-3-ENGL 2000 MB Lb@4bb O84L577 LS? a EUROPEAN STANDARD EN 124703 NORME EUROPEENNE EUROPAISCHE NORM arwary 2000 1cs 72003 English version Clinical thermometers — Part 3: Performance of compact electrical thermometers (norpredictive and predictive) with maximum device ‘Thermométres médicaux — ‘Medizinische Thermometer — Partie 3: Performances des thermométres. ‘Teil 3: Elecktrische (extrapolierende und nicht lectriques compacts (8 comparaison et & extrapolierende) Kompaktthermometer mit extrapolation) avec dispositif a maximum Maximumworrichtung, ‘This European Standard was approved by CEN on 13 May 1999. CEN members are bound to comply with the CEN/CENELEC Intemal Resulations which stipulate the conditions for giving this European Standard the status of a rational 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. ‘This European Standard exists in three official versions (English, French, German). A version in ary 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, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom, CEN European Committee for Standardization Comité Européen de Normalisation Europaisches Komitee fir Normung, Central Secretariat: rue de Stassart 36, B-1050 Brussels ‘© 2000 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref, No, EN 1247032000 E Copyright by the Buropean Commitee For Sanderdizaion Tue Mar 13 15:0045 2007STD-BSI BS EN J2470-3-ENGL 2000 MM Lb24bh9 084bS74 S59 a Page 2 EN 12470-3:2000 Foreword ‘This European Standard has been prepared by Technical Committee CEN/TC 205, Non-active medical devices, the Secretariat of which is held by BSL ‘This European Standard shall be given the status of a national standard, ether by publication of an identical text or by endorsement, at the latest by July 2000, and ‘conflicting national standards shall be withdrawn at the latest by July 2000. ‘This European Standard has been prepared under 2 ‘mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following ‘countries are bound to implement this European ‘Standard Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, EN 12470 consists ofthe following parts under the general tite “Clinical thermometers’: — Part 1: Metalic liquid-in-glass thermometers swith maximum device; — Part 2: Phase change-type (dot matrix) thermometers; — Part 8: Performance of compact electrical ‘thermometers (non-predictive and predictive) with ‘masvimum device; — Part 4:)) Performance of electrical thermometers Jor continuous measurements; — Part 5:2) Performance of infra-red ear thermometers (with maximum device). ‘Annexes A, B and ZA are informative. Performance requirements ‘Test methods Information supplied by the ‘manufacturer ‘Annex A (informative) Suggested types of ‘testing for the requirements of this standard Annex B (informative) Bibliography Annex ZA (informative) Clauses of this 3 4 5 Types of thermometers 6 7 8 nr | © BSI 04200STD-BSI BS EN M2Y70-2-ENGL 2090 MM Lb24LL9 OS4LS79 425 1 Scope ‘This part of EN 12470 specifies the performance ‘requirements for compact clinical electrical thermometers with maximum device (non-predictive and predictive). ‘This European Standard applies to devices that, when taking temperatures, are powered by an intemal power supply and that provide a digital indication of ‘temperature. ‘This European Standard does not apply to clinical 2 Normative references ‘This European Standard incorporates by dated or undated reference, provisions from other publications, ‘These normative references are cited at the ‘appropriate places in the text and the publications are listed hereafter. For dated references, subsequent aunendments to or revisions of any of these publications apply to this European Standard only ‘when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 960, Graphical symbols for use in the labelling of medical devices. EN 1041, Information supplied by the manayfacturer with medical devices. [prEN 12470-1:1008, Clinical thermometers — Part 1: Metallic tiquid-in-glass thermometers with ‘maximum device EN 6001-1, Medical electrical equipment — Part 1: General requirements for safety. EN 60601-12, Medical electrical equipment — Part 1: General requirements for safety — 2: Collateral Standard — ic compatibility — ‘Requirements and tests. 1SO 2850.2:1985, Sampling procedures for inspection ‘by attributes — Part 2: Sampling plans indexed by inviting quality (LQ) for isolated tot inspection. 8 Definitions For the purposes of this part of EN 12470 the following definitions apply. a compact electrical thermometer contact thermometer that consists of a temperature probe and an indicating unit permanently connected © BSH 04.2000 Cops bythe aren Commie For Sandan 46-2007 Page 3 EN 12470-3:2000 32 compact predictive thermometer device which calculates the maximum temperature of & probe in contact with a body cavity, without waiting for thermal equilibrium to occur, by heat transfer data and a mathematical algorithm and maintains the calculated maximum temperature value for a specified time or until reset by its user 33 compact non-predictive thermometer device with a part or function of the thermometer that monitors over a required period of time the ‘temperature measured by a temperature probe in ‘contact with a body cavity after which it indicates and ‘maintains the maximum temperanire value for a specified time or until reset by its user 34 indicating unit ‘component of the thermometer that processes the ‘outpit signal of the temperature sensor and displays the value of the temperature 35 maximum device part or function of the thermometer which stores and ‘indicates the numerical value of the maxinaam ‘temperature 36 temperature probe ‘component of the thermometer, part of which is applied to a body cavity and establishes temperature. Ti comprises a temperature sensor with associated parts including coverings, seals, and inner leads when necessary [NOTE A body cavity canbe the mouth, rectum, armpit or asorpharyn. 4 Unit ‘The unit of temperature shall be the degree Celsius, symbol °C. 5 Types of thermometers ‘The types of compact clinical electrical thermometers with maximum device shall be: a) nompredictive thermometers; ) predictive thermometers. 6 Performance requirements 6.1 Probe cover Ir protective probe covers are recomunended or ‘supplied by the manufacturer, the thermometer ‘together with the probe cover shall meet the requirements specified in this standard.STD-BSI BS EN 42470-3-ENGL 2000 MD LL24bb9 O8NbSAU LY? mt Page 4 EN 12470-3:2000 6.2 Metrological requirements 6.2.1 Measuring range ‘The thermometer shall cover the minimum measuring range from 35,5°C to 42,0°C. ‘The thermometer shall provide a visual or auditory ‘waming when the measured value of temperature is not within its specified measuring range. ‘Testing shall be carried out in accordance with 7.2. 6.2.2 Digital increment ‘The digital increment of the indicating unit shall be 0,1 °C oF less. ‘Testing shall be performed by visual inspection. 6.2.3 Maximum permissible error under reference conditions ‘The maximum permissible error for the measuring range 35,5 °C to 42,0°C shall be 0,1°C within the ambient temperature range from 18°C to 28°C. Outside ‘the measuring range of 35,5°C to 42,0°C or outside the ambient temperature range, the maximum permissible error shall not be greater than twice the specified value. ‘Testing shall be in accordance with 7.3. For predictive and non-predictive thermometers with ‘an offset, the manufacturer shall provide information 2) data obtained from the result of a clinical investigation; ) the procedure for testing in a water bath. 62.4 Time response When a non-predictive thermometer at a temperature ‘of @3£2)‘C is immersed into a water bath at (B7£1) °C for 60 s the indicated temperature shall not differ from the reference temperature by more than the ‘maximum permissible error. ‘Testing shall be performed in accordance with 74. 6.2.5 Maximum energy dissipation ‘The indicating unit shall provide an energizing potential sufficiently low so that the energy dissipation (ER) in the probe shall not cause an increase in indicated temperature by more than 0,01 °C when the probe is immersed in a reference water bath at @7£0) °C. ‘Testing shall be performed in accordance with 7.5. ‘coyight by the European Commitiee For Sandardizetion ve Mar 19 15:0048 2007 6.2.6 Long term stability ‘The long term stability of the thermometer, after exposing it for a minimum of 288h to a temperature of (65+2)°C, or for a minimum of 96h to a teruperature of (8022)°C, shal be such that the values for ‘maximum permissible errors specified in 6.2.8 are met. ‘Testing shall be performed in accordance with 7.6. 6.3 Environmental requirements 6.3.1 Ambient operating range ‘The minimum ambient operating range of the thermometer shall be from +10°C to +35 °C. ‘When tested in accordance with 7.7, the thermometer shall comply with 6.2.3. 682 Effect of storage ‘When tested in accordance with 7.8, the thermometer shall comply with 6.2.3, 63.3 Thermal shock ‘When tested in accordance with 7.9, the thermometer shall comply with 6.2.8, 63.4 Humidity ‘When tested in accordance with 7.10, the thermometer shall comply with 6.2.3, 635 Electromagnetic compatibility ‘The thermometer shall comply with EN 60601-1:2. 6.3.6 Mechanical shock ‘When tested in accordance with 7.11, thermometers with housing of plastic or metal shail comply with 6.2.3 63.7 Water resistance When tested in accordance with 7.12, the thermometer shall comply with 6.2.3. 64 Construction requirements 6.4.1 Functional units GA.1.1 Voltage limit indication ‘The thermometer shall automatically provide a visual or auditory waming when its supply voltage bs not ‘within specified limits and shall meet the mescimam. permissible errors in 6.2.8 when the voltage is within these specified limits, ‘Testing shalt be performed in accontance with 7.18. 6.4.1.2 Indicating unit Numerical values on the display, shall be at least 4 mm hhigh or optically magnified so as to appear that height. {fer poweron all seznets sal be activated fo at Is, ‘Testing shall be performed by visual inspection. 6.4.18 Functional safe test ‘The thermometer shall have a selftesting routine. The ‘carrect operation shall be indicated by a given display. ‘The manufacturer shall provide information #8 to how the selftesting routine operates and what display is to be expected. © RSI 04.2000STD.BST 8S EN W2470-3-ENGL 2000 MM Lb24bbS O84bS6L 083 a 6.4.2 Material ‘The thermometer shall be free from biological hazards. NOTE See EN 150 100004 forthe selection of appropriate test methods 65 Electrical safety ‘The thermometer shall comply with EN 60601-1 66 Mechanical safety 66.1 Thermometer ‘Thermometers shall not have sharp ends or angles that could injure the user or patient. ‘The temperature probe shall be smoothly rounded in order to prevent tissue damage during use. ‘Testing shall be performed by visual and tactile inspection. 6.6.2 Resistance to breakage A thermometer with a housing of glass shall comply ‘with 6.1.2.7 of prEN 12470-1:1998. 7 Test methods 7.1 General 7.1.1 Each individual lot shall be subjected to testing, either individual or statistical. For statistical testing, the lot shall be homogenous and thermometers from various sources shall nol be mixed. ‘The sampling plan shall correspond to TSO 286502:10985, Level I with limiting quality level LQ = 5% NOTE 1 Oster sampling plans can be wed i they are staustically equivalent. NOTE 2 For suggested type of testing see annex A 7.2 Method for the determination of the measuring range 72. Apparatus T2AA Reference thermometer, with an uncertainty in temperature reading not greater than £002 °C (Coverage factor k= 2), shall be used to determine the ‘temperature of the water bath. Its calibration shall be traceable to national measurement standards NOTE The definition ofthe coverage factor “kis found inthe *Calde tothe expression of uncersnty in measurement” 7212 Reference water bath, well regulated and stirred and containing at least 51 in volume shall be used to establish reference temperatures over the ‘measuring range. It shall be controlled to have a temperature stability of better than +0,02 °C over the specified measuring range of temperature of the thermometer to be tested. It shall have a temperature gradient of not greater than 40,01 °C within its working ‘Space at a specified temperature. ‘This temperature gradient shall be assured under all conditions and pattems of loading of thermometer samples. © BST o42000 Copyright by the Buropean Committee For Sandardizetion Tue Mar 13 15:00:46 2007 Page 5 EN 12470-32000 7.2.2 Procedure Immerse the temperature probe of a compact ‘thermometer to a depth according to the ‘manufacturer's specification ina reference water bath (7.2.1.2) at constant temperatures 0,3 °C below ‘the minimum and maximum values and 0,3 °C above ‘the minimum and maximum values of the measuring range specified by the manufacturer. The thermometer passes the test if the requirements of 6.2.1 are met. 7.2.3 Expression of results Report if temperatures are displayed or wamings are ‘pven, 7.3 Method of test for compliance with the maximum permissible error under reference conditions ‘7.3.1 Apparatus Use the apparanas described in 7.2.1 7.3.2 Reference conditions ‘The reference conditions for the requirements shall be an ambient temperanure of (23:£5)°C and a relative humidity of (50+ 20) % RH with the instrument operating within the specified range of the supply voltage. 7.3.3 Procedure 7.3.3.1 Immerse the temperature probe of a compact thermometer in the reference water bath until the thermometer has reached thermal equilibrium with the: ‘water bath or for the time period specified by the manufacture. 7.83.2. Compare the temperature indication of the thermometer to the indication of the reference thermometer (22-11) The difference between the and reference range of the instrument; however, measurements shall the measuring range to determine potential ‘small sub-ranges. This test shall be performed on at least 10 thermometers. Once itis verified that no inhomogeneities or resonances in small sub-ranges exist, the test shall be continued at a reduced number of temperature points (recomunended three points) ‘spaced approximately equally throughout the measuring range. ‘7.8.4 Expression of results For non-predictive thermometers calculate the error of the thermometer from the following expression: e=h— bat where 1; $s the temperature indicated at the thermometer to be tested; ti 38 the temperature of the water bath determined with the reference thermometer.STD.BSI BS EN 22470-3-ENGL 2000 MM 1b24bb9 O84LS82 TLT om Page 6 EN 12470-8:2000 For predictive thermometers or thermometers with an_ offset, calculate the error from the following. expression: em te ty where fe is the difference in °C specified by the ‘manufacturer for testing in a water bath after a specified immersion time. ‘TA Method of test for the determination of time response ‘7A.1 Apparatus Use the apparatus described in 7.2.1. 14.2 Procedure ‘74.21 Immerse the temperature probe of a compact thermometer at a temperature of (23+2)'C to a depth specified by the manufacturer in a water bath at a constant temperature of (37 1) °C for 60s and withdraw the thermometer. 7.422 Compare the temperature indication of the thermometer to the indication of the reference thermometer (7.2.1.1). The difference between the measured and reference temperatures shall meet the requirements specified in 6.2.4 7.5 Method of test for the determination of the maximum energy dissipation 7.5.1 Apparatus 7.5.1 Reference water bath, in accordance with 72.1.2, 7.5.12 Constant current power supply. 7.5.18 Calibrated voltmeter. 7.5.14 Calibrated ammeter. 7.5.2 Procedure 7.5.2.1 Disconnect the electrical leads of the specification at a temperature of (87 1)°C. 7.5.22 Apply a constant current to the temperature probe. Measure the applied current and voltage. Perform the measurements at three of more currents. The maximum power shall be 2 mW, ‘temperature) table for the probe type. Draw a linear (east squares fit) curve of temperature as a function of applied power. From this curve, determine the power corresponding to the maximum energy dissipation that ‘will cause a change in indicated temperature by 01°C. This value is the maximum power that can be provided by an indicating unit for the probe type and ‘the manufacturers specified value shall be equal to or Jess than the value determined. ‘opyrght by Une Buropean Commie For Btanderdization ue Mar 13 15.0047 2007 7.6 Method of test for the determination of the Jong term stability 7.6.1 Apparatus Temperature chamber, capable of producing temperatures necessary for testing. 7.6.2 Procedure lace the thermometer into the temperature chamber for 288 h at a temperature of (65: 2) °C ot for 96 h at a temperature of (80+ 2)°C. ‘Test according to 7.3 at three different temperatures smoced appreimatly equally ver the mening 7.7 Method of test for the determination of the ‘minimum amblent operating range ‘Testing shall be performed in accordance with 7.3 but ‘at an ambient temperature of (111) °C and (84+ 1)°C and with a water bath temperature of (37 1) C: 7.8 Method of test for the determination of the effect of storage 78.1 Apparatus Use the apparatus described in 7.6.1. 78.2 Procedure Store the thermometer in its unopened primary package for the following test cycle sequence: a) @4t Nhat ~@522)°C, b) GAS IDh at +2542) °C, ©) CALI at 16542)"; ) At Nhat +2542)°C, ©) G44 Ih at +25+2)°C. Remove the samples with their packaging unit intact from the temperature chamber (7.6.1) and allow them to remain at ambient temperature for at least 24h. ‘Then remove the thermometers from their packaging and complete the test in accordance with 7.8 at three different temperatures spaced approximately equally ‘over the measuring range. 7.9 Method of test: for thermal shock 79.1 Apparatus 7.9.1.1 Tho temperature chambers, capable of producing temperatures necessary for testing. 7.92 Procedure Place the thermometer in the temperature ‘chamber (7.9.1) for the following test cycles a) Lh ata temperature of (0+2) °C; b) 1h ata temperature af (65 +2)°C. Perform these test cycles five times. ‘The test samples shall be moved within 30 s from one to the other temperature chamber. ‘Then the thermometer shall be allowed to achieve thermal equilibrium at room temperature after which the requirements of 6.2.8 at a test temperature of (B71) °C shall be met. © Bst 042000STD-BSI BS EN L2470-3-ENGL 2000 MM Lb24Eb5 0846583 95b a 7.10 Method of testing for the effect of humidity 7.10.1 Apparatus 7.10.1.1 Climatic chamber, capable of producing an environment of (45:2) °C and (85+ 5) % relative humidity. 7.10.2 Procedure Place the thermometer into te climatic chamber (7.10.1) at a temperature of (45: 2)°C and a relative humidity of (85:5) % RH for 48h. Remove the thermometer from the climatic chamber and allow it to achieve thermal equilibrium at room ‘temperature. Testing shall be performed in accordance with 7.8 at three different temperatures spaced ‘approximately equally over the measuring range. 7.11 Method of test for mechanical shock 7.11.1 Apparatus Ablock of hard wood of density greater than 700 ke'm? and of suitable size lying flat on a rigid base, 7.112 Procedure The thermometer shall be permitted to fall freely through a vertical distance of 1m onto the hard surface (7.11.1). This drop shall be performed once for each of three physical onentations of the complete thermometer. ‘Subsequent testing shall he perfarmed in accordance with 7.3 at a temperanare of (37: 1)°C. 7.12 Method of test for water resistance Immerse the thermometer without any additional covering completely in water in its service position as specified by the manufaccurer 30 that the following conditions are satisfied: 4) the highest point of the thermometer is located at Teast 15cm below the surface of the water; 1b) the duration of the test is (801) min, Subsequent testing shall be performed in accordance with 7.3 af a temperazure of (37 1)°C. 7.13 Method of test for the voltage limit 7.13.1 Apparatus Direct current voltage supply. 7.18.2 Procedure Replace the intemal power supply by a variable de. voltage supply (7.18.1). Adjust the voltage of the supply until a low battery indication or warning signal is activated at a level ‘specified by the manufacturer. Test in accordance with 7. at the lower and upper ends of the temperature measuring range at ambient temperature. Ifthe thermometer has no replaceable power supply, it Js necessary to modify the thermometer to be ‘connected to an external power supply. © BSI 0420 Copytiht by the European Committe For Standardization Tue Mar 13 15:0047 2007 Page 7 EN 1247032000 8 Information supplied by the manufacturer 8.1 General Information supplied by the manufacturer shall comply ‘with the specification given in EN 1041. If symbols are used, they shall be in accordance with EN 950, 8.2 Marking In addition to 8.1 the thermometer shall be marked with at least the following information: a) the symbol “°C” adjacent to the numerical value, If not indicated at the display; ) body site (eg. mouth, rectum), if restrictions NOTE Twa can spl to peeve emaneter. ©) waming “not watertesistant” or an equivalent statement, ifthe thermometer is not in conformance with 6.8.7 83 Instructions for use In addition to 8.1 the thermometer shall be accompanied by instructions for use containing at least ‘the following information: 8) information about the proper environmental conditions of nse, storage and transport; ') disposal of the thermometer and its batteries; ©) reference to this Buropean Standard and the relevant par, including the complete title; 4) instructions for proper cleaning and disinfection; ©) measuring range and maximum permissible error under reference conditions, ‘instructions for the functional safe test; 4) instructions for selection and replacement of, battery, if applicable; h) probe cover usage, if applicable; 4) body site (e.g, mouth, rectum); 4) recommended minimum measuring time at the ‘specific body site; 1) recommended maintenance and calibration procedure, including frequency of recalibration; 1) information on whether the thermometer is a predictive type and, if an offset is used, the specification of the offset.STD-BSI BS EN 22470-3-ENGL 2000 MM b24Lb9 D84ES84 892 mm Page 8 EN 12470-32000 Annex A (informative) ‘Table A.1 — Suggested tests (continued) Suggested types of testing for the Cee ne | requirements of this standard eaene In order to comply with the requirements of the (Long term stability) EU declaration of conformity thermometers have to beggar comply with the requirements of either: f ing ronge) 2) annex II or a we ~ ) annex VIE coupled with annex IV or annex Vor | Cetvect of storage) ‘annex VI of the EU Directive for Medical Devices 98/42/EEC of 14 June 1993, 6387.9 shock) ‘Annex A informs and recommends on the volume of | Thermal testing suggested to comply with the requirements of | [6.3.5/EN 60001-12 the Medical Device Directive. EMC) - ‘The tests described in this standard should be 63.67.11 performed as follows. (Mechanical shock) 1) Type A: Tests that should be performed like type [6.3.777.12 ‘examination tests. After initial verification of the (Water resistance) x corresponding requirements these tests aretobe | ga.LATAB repeated as frequently as required to guarantee a | (Voitage int indication) ‘uniform production or product. The tests are to be ove boos repeated whenever a relevant design or component | 641-2Viual inspection x wn appropriate cities These tests are where compliance with ; the requirements of the standard can be (Functional safe test) x demonstrated by investigating a small number 64QEN 150 100051 (pically 10) of samples of the product. (Material) 2) Type B: Tests that show each lot of product 6.5/EN 606011 ‘complies with the requirements of the standard. (lectrical safety) Tests according to Table A1 should be performed on .6.1/Visual and taclle apection ~~ gach sample of according toa statistical sampling plan | (chara sale) x toner he EU Direct for Mecca Dees [2626127 of EN EATOTIIDE | S0/4Y/EEC. Resistance to breakage) ‘8.2Nisual inspection ‘Table A.1 — Suggested tests Marking) x Clauses on the requirements and text | Lat by Tot ‘methods testing pe | |S Se pe x 62.172 NOTE ‘ype A testing is copa fora Measuring range) laazes 62.2Nisal (ightal increment) Annex B (informative) 6.2.87.8 Bibliography terion pesriseble ever) x EN ISO 1966-1, Biotogioal evaluation of medial 624A devices — Part 1: Evaluation and testing (ime response) (C80 10998-1:1997) 62575 GUM 1983, Guide to the axpression of uncertainty in (Qiaximum energy dissipation) ‘measurement. opyrihtby the Europesn Committee For Standardization ve Mar 19 15:0047 2007 © BSI 04.2000STD-BSI BS EN 22470-3-ENGL 2000 MM Lb24bb4 O84b585 725 a Page 9 EN 12470-32000 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives ‘This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association and supports essential requirements of EU Directive for Medical Devices SG42/EEC, WARNING, Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard. =~ ‘The following clauses of this standard are likely to support requirements of Directives 9@/42/EEC. Compliance with this standard provides one means of conforming with the specific essential requirements of the Directive concemed and associated EFTA regulations. ‘Table ZA.1— Correspondence between this European Standard and EU Directives ‘Clansc/eubclause of tis European | Corresponding Essential Requirement Comments Standard fof Directive S942EEC 4 103, € 128,45 62 ior | 626 92 1 63 9:2, 10.1 635 a2 63.7 (6 ~ ati Toi, 122 aid 102 65 92 661 92,1271 662 92 7 023.45 72,73, 74,75 TA 76, 77, 78, 79, 7.10, 711 92,101 [742 7.6, 9.2, 10.1 713 92, 10.1, 122 ‘81, 82 12.9, 18.1 25) 103 820) 13.3), 13.3) 820) 13.3) 33 18.1, 19.64), 13.60) ‘83b) ~_ [18.30 83a) Bi, 18.68) 830) 13.69) 830) 18a) | © BS 042000 Cen by the argon Coan For Sndraton ee S suet BorSTD-BSI BS EN 12470-3-ENGL 2000 MM Lb24bb9 OB4LS8b bbs mm BS EN 12470-3:2000 389 Chiswick High Road Wa 4AL BSI — British Standards Institution BSI is the independent national body responsible for preparing British Standards. 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