bs en 12470-3.pdf

STD. BSI SS: EN 12 1InJ.-3ENtiL 2000 1624669 []al~657 5 88T BRfinSHSTANDARD BSEN

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 status of a British Standard

ICS 11.040.55

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Copyright by the European Committee For Standardization Tue Mar 13 15:00:10 2007

12470-3:2000

STD. BSI DS EN 121.J70-3-'EN6L 2001] 1624669 0846516 116 BS EN 12470-3:2000

This British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 April 2000

BSI 04-2000

ISBN 0 580 34605 6

National foreword This British Standard is the official English language version of EN 1247~:2000. The UK participation in its preparation was entrusted by Technical Conunittee LBItJ6, Laboratory glassware and related apparatus, to Subconunittee LBItJ6tJ, Thenuometers, which has the responsibility to:

- aid enquirers to understand the text;

- present to the responsible European conunittee any enquiries on the interpretation, or proposals for change, and keep the UK interests infonued;

- monitor related international and European developments and promulgate them in the UK.

A list of organizations represented on this subconunittee can be obtained on request to its secretary. Cross-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 Correspondence Index", or by using the "Find" facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necess&y 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 2 to 9 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued.

Amendments issued since publication AmdNo. Date Corrunents


STD. BSI as EN 12 lI7U":l-ENGL 20UO lbt!'fbb9 08465."77 6!i2 _

EUROPEAN SfANDARD NORME EURopEENNE EUROPAIscHE NORM

EN 12470-3

Janwuy 2000

ICS 17.200.20

English version

Clinical thennometers -Part 3: PeIfonnance of compact electrical thennometers

(non-predictive and predictive) with rnaxinll.Hn device

Thennometres medicaux -Partie 3: Perfonnances des thennometres electriques compacts (a comparaison et a extrapolation) avec dispositif a maximum

Medizinische Thennometer -Thil3: Elecktrische (extrapoJierende md nicht extrapoJierende) Kompaktthennometer mit Maximumvonichtung

This European Standard was approved by CEN on 13 May 1999. CEN members are boWld to comply with the CEN/CENELEC Internal 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. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation Wlder 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, Gennany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

CEN European Committee for Standardization

Comite Europeen de Nonnalisation Europaisches Komitee fur Normung

Central Secretariat: rue de Stassart 36, B-I050 Brussels

2000 CEN All rights of exploitation in any form and by any means reseIVed worldwide for CEN national Members.


Ref. No. EN 1247~:2000 E

STD.BSI BS EN 12~!7D-3[NGL 2[][][) l.b246b9 08lfb578 599 ., Page 2 EN 12470-3:2000

Foreword This European Standard has been prepared by Technical Committee CENII'C 205, Non-active medical devices, the Secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either 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 a 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 infonnative 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, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. This European Standard applies to clinical thennometers which are used for measuring the body temperature of humans. EN 12470 consists of the following parts under the general title "Clinical thennometers":

- Part 1: Metallic liquid-i~glass thermmneters with, mo:x:imum device; - Part 2: Phase ch4nge-type (dot matrix) themurmeters; - Part 3: Performance of cmnpact elEctriool themurmeters (non-predictive and predictive) with maximum device; - Part 4:1) Peiformance of elEctrical tJwrrrwmeters for rontinuous measurements; - Part 5:1) Peiformance of irifra-red ror thermometers (with, 1rULXimum device).

Annexes A. B and ZA are infonuative.

1) In preparation.


Contents

Foreword 1 Scope 2. Nonnative references 3 Definitions 4 Unit 5 'JYpes of thennometers 6 Performance requirements 7 Test methods 8 Information supplied by the

manufacturer Annex A (infonnative) Suggested types of testing for the requirements of this standard Annex B (Wonnative) Bibliography Annex ZA (infonnative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives

Page 2 3 3 3 3 3 3 5

7

8 8

9

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1 Scope This part of EN 12470 specifies the performance requirements for compact clinical electrical thennometers with maximum device (non-predictive and predictive). This European Standard applies to devices that, when taking temperatures, are powered by an internal power supply and that provide a digital indication of temperature. This European Standard does not apply to clinical electrical thennometers for continuous measurement and thermometers intended to measure skin temperature.

2 Nonnative references This European Standard inCOlporates by dated or undated reference, provisions from other publications. These nonnative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments 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 980, Graphical symbols far use in the labelling of medical devices. EN 1041, Informatitm supplied by the manufacturer with medical devices. prEN 12470-1:1998, Clinical thermometers-Part 1: Metallic liquid-in-glass thermometers with maximum de/Jice. EN 60601-1, Medical electrical equipment-Part 1: General requirements far safety. EN 60601-1-2, Medical electrical equipment-Part 1: General requirements far safety - 2: Collateral Standard - Electromagnetic compatibility -Requirements and tests. ISO 2859-2: 1985, Sampling procedures for inspectitm by attributes - Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspectitm.

S Definitions For the purposes of this part of EN 12470 the following definitions apply.

3.1 compact electrical thermometer contact thermometer that consists of a temperature probe and an indicating unit pennanently connected together

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3.2

PageS EN 12470-3:2000

compact predictive thermometer device which calculates the maximum temperature of a 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 3.3 compact non-predictive thermometer device with a part or function of the thennometer 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 temperature value for a specified time or until reset by its user 3.4 indicating unit component of the thermometer that processes the output signal of the temperature sensor and displays the value of the temperature

3.5 maximum device part or function of the thermometer which stores and indicates the numerical value of the maximum temperature

3.6 temperature probe component of the thennometer, part of which is applied to a body cavity and establishes temperature. It comprises a temperature sensor with associated parts including coverings, seals, and inner leads when necessary NOTE A body cavity can be the mouth, rectum, armpit or naso-pharynx.

4 Unit The unit of temperature shall be the degree Celsius, symbolC.

5 'JYpes of thennometers The types of compact clinical electrical thennometers with maximum device shall be:

a) non-predictive thermometers; b) predictive thermometers.

6 Performance requirements 6.1 Probe cover If protective probe covers are recommended or supplied by the manufacturer, the thennometer together with the probe cover shall meet the requirements specified in this standard

STD. BSI as EN 12~7[1'-3-[N{;L 2000 1b2~bb9 08 l lb5lH! 1~7 page4 EN 12470-3:2000

6.2 Metrological requirements 6.2.1 Measuring range The thermometer shall cover the minimum measuring range from 35,5C to 42,0 DC. The thermometer shall provide a visual or auditoty warning when the measured value of temperature is not within its specified measuring range. Testing shall be canied out in accordance with 7.2. 6.2.2 Digital increment The digital increment of the indicating unit shall be 0,1C or 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 OC to 42,0 C shall be 0,1 C within the ambient temperature range from 18C to 28 QC. Outside the measuring range of 35,5 C to 42,0C 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 on:

a) data. obtained from the result of a clinical investigation; NOTE For this investigation predictive thermometers can be modified by incorporating a switch to allow operation alternatively in predictive and non-predictive mode. In the non-predictive mode the thermometer should meet the requirements of 6.2.3 when tested according to 7.2. In this case the thermometer is tested in the predictive mode and read, then the mode is switched to non-predictive and the temperature is read again after achieving thermal equilibrium. The two temperature readings should not differ by more than 0,2 C for more than 98 % of the subjects. In the case that the thermometer to be investigated cannot be modified accordingly, it should be compared against a calibrated clinical reference thermometer, preferably at the same body site. Selection of test persons should be in accordance with the intended use of the thermometer. The clinical test should be performed in accordance with Annex X of the Medical Device Directive (MOD). b) the procedure for testing in a water bath.

6.2.4 71me response When a non-predictive thermometer at a temperature of (23 2) C is immersed into a water bath at (37 1) C for 60 s the indicated temperature shall not differ from the reference temperature by more than the maximum pennissible error. Testing shall be performed in accordance with 7.4. 6.2.6 Maximum errergy dissipation The indicating unit shall provide an energizing potential sufficiently low so that the energy dissipation (j2.R) 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 (37 0,1) QC. Testing shall be performed in accordance with 7.5.


6.2.6 Long term stability The long term stability of the thermometer, after exposing it for a minimum of 288 h to a temperature of (55 2) QC, or for a minimum of 96 h to a temperature of (SO 2) cC, shall be such that the values for maximum pennissible errors specified in 6.2.3 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 qc. When tested in accordance with 7.7, the thermometer shall comply with 6.2.3. 6.3.2 ~ect of storaqe When tested in accordance with 7.8, the thermometer shall comply with 6.2.3. 6.3.3 Thermal shock When tested in accordance with 7.9, the thermometer shall comply with 6.2.3. . 6.3.4 Humidity When tested in accordance with 7.10, the thermometer shall comply with 6.2.3. 6.3.5 Electromagrretic compatibiUty The thermometer shall comply with EN 60601-1-2. 6.3.6 Mechanical shock When tested in accordance with 7.11, thermometers with a housing of plastic or metal shall comply with 6.2.3. 6.3.7 Water resistance When tested in accordance with 7.12, the thermometer shall comply with 6.2.3. 6.4 Construction requirements 6.4.1 Functional rmits 6.4.1.1 Voltage limit indication The thermometer shall automatically provide a visual or auditory warning when its supply voltage is not within specified limits and shall meet the maximum permissible errors in 6.2.3 when the voltage is within these specified limits. Testing shall be performed in accordance with 7.13. 6.4.1.2 Indicating unit Numerical values on the display, shall be at least 4 mm high or optically magnified so as to appear that height After power-on all segments shall be activated for at least 1 s. Testing shall be performed by visual inspection. 6.4.1.3 Functional safe test The thermometer shall have a self-testing routine. The correct operation shall be indicated by a given display. The manufacturer shall provide information as to how the self-testing routine operates and what display is to be expected.

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STD. BSI 8S EN 1i?47D-3-ENGL t~UDD _ 1624669 084b581 [)83 _

6.4.2 Malerial The thennometer shall be free from biological hazards. NOTE See EN ISO 10993-1 for the selection of appropriate test methods.

6.5 Electrical safety The thennometer shall comply with EN 60601-1. 6.6 Mechanical safety 6.6.1 Themwmeter Thennometers shall not have shalp ends or angles that could iI\jure the user or patient The temperature probe shall be smoothly rounded in order to prevent tissue damage during use. Testing shall be perfonned by visual and tactile inspection.

6.6.2 Resistance to breakage A thennometer with a housing of glass shall comply with 6.1.2.7 of prEN 12470-1:1998.

7 Thst 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 thennometers from various sources shall not be mixed The sampling plan shall correspond to ISO 2859-2: 1985, Level n with limiting quality level LQ = 5 %. NOTE 1 Other sampling plans can be used if they are statistically equivalent. NOTE 2 For suggested types of testing see annex A.

7.2 Method for the determination of the measuring range 7.2.1 Apparatus 7.2.1.1 Rliference thermometer, with an uncertainty in temperature reading not greater than O,02 C (coverage factor k = 2), shall be used to detennine the temperature of the water bath. Its calibration shall be traceable to national measurement standards NOTE The definition of the coverage factor Ok" is found in the "Guide to the expression of uncertainty in measurement".

7.2.1.2 Reference water bath, well regulated and stirred and containing at least 5 I 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 O,02 C over the specified measuring range of temperature of the thennometer to be tested. It shall have a temperature gradient of not greater than O,O! C within its working space at a specified temperature. This temperature gradient shall be assured under all conditions and patterns of loading of thennomet.er samples.

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7.2.2 Procedure

Page 5 EN 12470-3:2000

Inunerse the temperature probe of a compact thermometer to a depth according to the manufacturer's specification in a reference water bath (7.2.1.2) at constant temperatures 0,3C 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 thennometer passes the test if the requirements of 6.2.1 are met 7.2_3 Expression of results Report if temperatures are displayed or warnings are given. 7.3 Method of test for compliance with the maximum permissible error under reference conditions 7.3.1 Apparatus Use the apparatus described in 7.2.1. 7.3.2 Rfd"erence conditions The reference conditions for the requirements shall be an ambient temperature 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 Inunerse 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 manufacturer. 7.3.3.2 Compare the temperature indication of the thennometer to the indication of the reference thennometer (7.2.1.1). The difference between the measured and reference temperatures shall meet the requirements specified in 6.2.3. 7.3.3.3 The number of measurements at different temperatures required depends upon the measuring range of the instrument; however, measurements shall be perfonned at least at every full degree Celsius of the measuring range to detennine potential inhomogeneities or resonances that can cause the exceeding of the maximum permissible error in small sub-ranges. This test shall be perfonned on at least 10 thennometers. Once it is verified that no inhomogeneities or resonances in small sub-ranges exist, the test shall be continued at a reduced number of temperature points (recommended three points) spaced approximately equally throughout the measuring range. 7.3.4 Expression of results For non-predictive thennometers calculate the error of the thennometer from the following expression:

e=lj-fwb where

~ is the temperature indicated at the thennometer to be tested;

fwb is the temperature of the water bath determined with the reference thennometer.

STD.BSI BS EN 12lf70-3-ENGL 20[]O 1624669 []846582 T1T page6 EN 12470-3:2000

For predictive thennometers or thennometers with an offset, calcuJate the error from the following expression:

e=lj-tc-twb where

tc is the difference in C specified by the manufacturer for testing in a water bath after a specified inunersion time.

7.4 Method of test for the determination of time response 7.4.1.Apparalus Use the apparatlE described in 7.2.l. 7.4.2 Procedure 7.4.2.1 Immerse the temperature probe of a compact thennometer 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 60 s and withdraw the thennometer. 7.4.2.2 Compare the temperature indication of the thennometer to the indication of the reference thennometer (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 7.5.1.1 &iference water bath, in accordance with 7.2.1.2. 7.5.1.2 Constant current power supply. 7.5.1.3 Calibrated voltmeter. 7.5.1.4 Calibrated ammeter. 7.5.2 Procedure 7.5.2.1 Disconnect the electrtcal leads of the temperature probe from the indicating unit Connect them to the constant power suppJy and the measuring instruments. Immerse the thennometer in the reference water bath in accordance with the manufacturer's specification at a temperature of (37 1) QC. 7.5.2.2 Apply a constant current to the temperature probe. Measure the applied current and voltage. Perfonn the measurements at three or more currents. The maximum power shall be 2 mW. 7.5.2.3 Expression of results Calcu1ate the equivalent resistance values and then convert them to temperature values using the manufacturer's characteristic (resistance vs. temperature) table for the probe type. Draw a linear (least squares fit) CUIVe of temperature as a function of applied power. From this curve, detennine the power corresponding to the maximum energy dissipation that will cause a change in indicated temperature by 0,01 cC. 1bis value is the maximum power that can be provided by an indicating unit for the probe type and the manufacturer's specified value shall be equal to or less than the value detennined


7.6 Method of test for the determination of the long term stability 7.6.1.Apparatus Temperature chamber, capable of producing temperatures necessary for testing. 7.6.2 Procedure Place the thennometer into the temperature chamber for 288 h at a temperature of (55 2) C or for 96 h at a temperature of (80 2) QC. Test according to 7.3 at three different temperatures spaced approximateJy equally over the measuring range.

7.7 Method of test for the determination of the minimum ambient operating range Testing shall be perfonned in accordance with 7.3 but at an ambient temperature of (11 1) C and (34 1) C and with a water bath temperature of (37 1) CC. 7.8 Method of test for the determination of the effect of storage 7.8.1.Apparalus Use the apparatus described in 7.6.1. 7.8.2 Procedure Store the thennometer in its unopened primary package for the following test cycle sequence:

a) (24 1) h at -(25 2) QC; b) (24 l)h at +(252) cC; c) (24 1) hat +(55 2) QC; d) (24 l)h at +(252)OC; e) (24 1) h at +(25 2) QC.

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 24 h. Then remove the thennometers from their packaging and complete the test in accordance with 7.3 at three different temperatures spaced approximateJy equalJy over the measuring range.

7.9 Method of test for thermal shock 7.9.1.Apparatus 7.9.1.1 7Wo temperature chambers, capable of producing temperatures necessary for testing. 7.9.2 Procedure Place the thennometer in the temperature chamber (7.9.1) for the following test cycles:

a) 1 h at a temperature of (0 2) QC; b) 1 h at a temperature of (55 2) QC.

Perform these test cycles five times. The test samples shall be moved within 30 s from one to the other temperature chamber. Then the thennometer shall be allowed to achieve thennal equilibrium at room temperature after which the requirements of 6.2.3 at a test temperature of (37 1) C shall be met

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STD.BSI BS EM 12470-3-ENGL 2000 .. 1624669 0846583 956 ..

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 hwnidity. 7.10.2 Procedure Place the thennometer into the climatic chamber (7.10.1) at a temperature of (45 2) C and a relative humidity of (85 5) % RH for 48 h. Remove the thermometer from the climatic chamber and allow it to achieve thennal equilibrium at room temperature. Testing shall be performed in accordance with 7.3 at three different temperatures spaced approximately equally over the measuring range. 7.11 Method of test for mechanical shock 7.11.1 Apparatus A block of hard wood of density greater than 700 kWm3 and of suitable size lying flat on a rigid base. 7.11.2 Procedure The thermometer shall be permitted to fall freely through a vertical distance of 1 m onto the hard surface (7.11.1). This drop shall be performed once for each of three physical orientations of the complete thermometer. Subsequent testing shall be performed in accordance with 7.3 at a temperature of (37 1) cc. 7.12 Method of test for water resistance hrunerse the thermometer without any additional covering completely in water in its service position as specified by the manufacturer so that the following conditions are satisfied:

a) the highest point of the thermometer is located at least 15 cm below the surface of the water; b) the duration of the test is (30 1) min.

Subsequent testing shall be performed in accordance with 7.3 at a temperature of (37 1) cc. 7.13 Method of test for the voltage limit 7.13.1 Apparatus Direct current voltage supply.

7.13.2 Procedure Replace the internal power supply by a variable de. voltage supply (7.13.1). Acijust 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 7.3 at the lower and upper ends of the temperature measuring range at ambient temperature. If the thermometer has no replaceable power supply, it is necessary to modify the thermometer to be connected to an external power supply.

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Page 7 EN 12470-3:2000

8 Infonnation 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 980. 8.2 Marking In addition to 8.1 the thermometer shall be marked with at least the following infonnation:

a) the symbol "OC" adjacent to the numerical value, if not indicated at the display; b) body site (e.g. mouth, rectum), if restrictions apply; NOTE This can apply to predictive thennometers. c) warning "not water-resistant" or an equivalent statement, if the thermometer is not in conformance with 6.3.7.

8.3 Instructions for use In addition to 8.1 the thermometer shall be accompanied by instructions for use containing at least the following information:

a) information about the proper environmental conditions of use, storage and transport; b) disposal of the thermometer and its batteries; c) reference to this European Standard and the relevant part, including the complete title; d) instructions for proper cleaning and disinfection; e) measuring range and maximum permissible error under reference conditions; t) instructions for the functional safe test; g) instructions for selection and replacement of battery, if applicable; h) probe cover usage, if applicable; i) body site C e.g. mouth, rectum); j) recommended minimum measuring time at the specific body site; k) 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 12470-3-ENGL 2000 11 1624669 0846S8~ 892 .. PageS EN 12470-3:2000

Annex A (informative) Suggested types of testing for the requirements of this standard In order to comply with the requirements of the EU declaration of confonnity thermometers have to comply with the requirements of either:

a) annex IT; or b) annex VII coupled with annex IV or annex Vor annex VI of the EU Directive for Medical Devices 931421EEC of 14 June 1993.

Annex A infonns and recommends on the volume of testing suggested to comply with the requirements of the Medical Device Directive. The tests described in this standard should be performed as follows.

1) Type A:. Tests that should be performed like type examination tests. After initial verification of the corresponding requirements these tests are to be repeated as frequently as required to guarantee a uniform production or product. The tests are to be repeated whenever a relevant design or component change is performed These tests are appropriate where compliance with the requirements of the standard can be demonstrated by investigating a small number (typically 10) of samples of the product. 2) Type B: Tests that show each lot of product complies with the requirements of the standard

Tests according to Table A 1 should be performed on each sample or according to a statistical sampling plan that complies with the requirements of chapter 6 of annex IV of the EU Directive for Medical Devices 93142/EEC.

Table A.l - Suggested tests Clauses on the requirements and test Lot by lot

methods testing, 1YPe B 6.2.117.2 (Measuring range) 6.2.2IVJSUal inspection (Digital increment) 6.2.M.S (Maximum pennissible error) X 6.2.417.4 (TIme response) 6.2.5n.5 (Maximum energy dissipation)


Table A.l - Suggested tests (cantinued) Clauses on the requirements and test

methods 6.2.617.6 (Long term stability) 6.3.117.7 (Ambient operating range) 6.3.2n.8 (Effect of storage) 6.S.3n.9 (Thermal shock) 6.S.5IEN 60601-1-2 (EMC) 6.3.M.ll (Mechanical shock) 6.3.7n.12 (Water resistance) 6.4.1.117.13 (Voltage limit indication) 6.4.1.2IVJSual inspection (Indicating unit) 6.4.1.S/VJSUal inspection (Functional safe test) 6.4.2IEN ISO 10993-1 (Material) 6.51EN 60601-1 (Electrical safety) 6.6.INISUal. and tactile inspection (Mechanical safety) 6.6.216.1.2.7 of prEN 12470-1:1998 (Resistance to breakage) 8.2IVJSUal inspection (Marking) 8.3/VJSual inspection (Instructions for use) NOTE 'JYpe A testing is compulsory for all clauses.

Annex B (informative) Bibliography

Lot by lot testing, 1YPe B

X

X

X

X

X

X

X

EN ISO 10993-1, Biological evol:uatian of medical deuices - Part 1: Evaluation and testing (ISO 10993-1:1997). GUM 1993, Guide to the expression of uncertainty in measurement.

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Annex ZA (infonnative)

Page 9 EN 12470-3:2000

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 Conunission and the European Free 'frade Association and supports essential requirements of EU Directive for Medical Devices 931421EEC. 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 931421EEC. Compliance with this standard provides one means of conforming with the specific essential requirements of the Directive concerned and associated EFfA regulations.

Table ZA.1- Correspondence between this European Standard and EU Directives Clause/subclause of this European

Standard

4 6 6.2 6.2.6 6.3 6.3.5 6.3.7 6.4.1.1 6.4.1.2 6.5 6.6.1 6.6.2 7 7.2, 7.S, 7.4, 7.5 7.6, 7.7, 7.8, 7.9, 7.10, 7.11 7.12 7.13 8.1,8.2 8.2a) 8.2b) 8.2c) 8.3 8.3b) 8.3d) 8.3e) 8.Sf)

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Corresponding Essential Requirement Comments of Directive 931421EEC

10.3 1,2,3,4,5 10.1 9.2 9.2,10.1 9.2 7.6 10.1,12.2 10.2 9.2 9.2,12.7.1 9.2 1, 2, S,4, 5 7.1 9.2, 10.1 7.6, 9.2, 10.1 9.2, 10.1, 12.2 12.9,13.1 10.3 13.3i), lS.3j) 13.3k) 13.1, lS.6a), 13.6b) lS.3n) 8.1,13.6h) lS.6p) lS.6d)

STD.BSI BS EN 1247D-3-ENGL 2DDD .. 1624669 D846586 665 .. BSEN 12470-3:2000

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