1、BRITISH STANDARD BS EN 12470-2:2000 Clinical thermometers Part 2: Phase change type (dot matrix) thermometers ICS 11.040.55 NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAW +A1:2009National foreword This British Standard is the UK implementation of EN 12470-2:2000+A1:2009. It supersedes
2、BS EN 12470-2:2001, which is withdrawn. The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to CEN text carry the number of the CEN amendment. For example, text altered by CEN amendment A1 is indicated by !“. The UK participation
3、in its preparation was entrusted to Technical Committee LBI/36, Laboratory equipment and related glassware. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. User
4、s are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. BS EN 12470-2:2000+A1:2009 This British Standard was published under the authority of the Strategy Committee and comes into effect on 15 June 2001 BSI 2009 Amendments/corr
5、igenda issued since publication Date Comments 31 August 2009 Implementation of CEN amendment A1:2009, and alignment of BSI and CEN publication dates ISBN 978 0 580 65152 6 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12470-2:2000+A1 June 2009 ICS 17.200.20 Supersedes EN 12470-2:2000 English
6、Version Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers Thermomtres mdicaux - Partie 2: Thermomtres changement de phase (matrice points) Medizinische Thermometer - Teil 2: Phasenumschlagthermometer (Punktmatrix) This European Standard was approved by CEN on 16 September 2
7、000 and includes Amendment 1 approved by CEN on 16May 2009. CEN members are bound 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 refere
8、nces concerning such national standards may be obtained on application to the CEN Management Centre 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 under the responsibility of a CEN member i
9、nto its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latv
10、ia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brusse
11、ls 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12470-2:2000+A1:2009: EEN 12470-2:2000+A1:2009 (E) 2 Contents Page Foreword 3 1 Scope 4 2 Normative references 4 3 Terms and definitions .4 4 Unit 5 5 Type of thermometers .5
12、6 Requirements .5 7 Test methods 7 8 Information supplied by the manufacturer 10 Annex A (informative) Suggested types of testing for the requirements of this standard . 13 Annex ZA (informative) ! ! ! !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/
13、EEC“ “ “ “ . 15 Bibliography . 17 BS EN 12470-2:2000+A1:2009EN 12470-2:2000+A1:2009 (E) 3 Foreword This document (EN 12470-2:2000+A1:2009) has been prepared by Technical Committee CEN/TC 205 “Non- active medical devices“, the secretariat of which is held by DIN. This European Standard shall be given
14、 the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. This document includes Amendment 1, approved by CEN on 2009-05-16. This document supers
15、edes EN 12470-2:2000. The start and finish of text introduced or altered by amendment is indicated in the text by tags ! “. 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
16、 EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. This European Standard applies to clinical thermometers which are used for measuring the body temperature of humans. EN 12470 consists of the following Parts under the gener
17、al title “Clinical thermometers”: Part 1: Metallic liquid-in-glass thermometers with maximum device Part 2: Phase change type (dot matrix) thermometers Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device Part 4: Performance of electrical thermom
18、eters for continuous measurement Part 5: Performance of infra-red ear thermometers (with maximum device) Annexes A and ZA are informative. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard:
19、 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. BS EN 12
20、470-2:2000+A1:2009EN 12470-2:2000+A1:2009 (E) 4 1 Scope This Part of EN 12470 specifies performance requirements and test methods for phase change-type (dot matrix) thermometers for measuring temperature in body cavities. NOTE A body cavity can be the mouth, rectum or armpit. This European Standard
21、does not apply to clinical thermometers designed for special applications (e.g. thermometers for hypothermia) which owing to their measurement range, scale interval or maximum permissible error do not meet the requirements specified in this Standard. 2 Normative references This European Standard inc
22、orporates by dated or undated reference, provisions from other publication. These normative 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 Eur
23、opean Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN 980, !Symbols for use in the labelling of medical devices“ EN 1041, Information supplied by the manufacturer with medical
24、devices EN 556+A1, Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled “Sterile“ ISO 2859-2:1985, Sampling procedures for inspection by attributes Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection 3 Terms and defi
25、nitions For the purposes of this Part of EN 12470, the following terms and definitions apply: 3.1 measurement time length of time required to measure body temperature 3.2 phase change (dot matrix) thermometer device utilising a change in state of chemical components designed to measure and indicate
26、human body temperature 3.3 retention time duration of time for which the optimal signal for reading persists 3.4 sensor matrix temperature measuring area consisting of temperature dots NOTE The dots contain different chemical mixtures, which change their state at specific temperatures. This change i
27、s accompanied by a change in appearance, e.g. change of colour. When in contact with the temperature site being measured, the change of state takes place in the sequence of dots up to and including the dot corresponding to the temperature of the site. This dot indicates the site temperature. BS EN 1
28、2470-2:2000+A1:2009EN 12470-2:2000+A1:2009 (E) 5 3.5 temperature offset designed difference between preadjusted thermometer reading and water bath temperature after reaching thermal equilibrium 3.6 preadjusted thermometer thermometer which is designed to have a temperature offset 3.7 skipped dot a d
29、ot which fails to activate when exposed to a temperature which would have caused activation 3.8 adjacent dots dots which are numerically sequential according to the scale 3.9 storage package smallest original shipping unit used by the manufacturer 4 Unit The unit of temperature shall be the degree C
30、elsius, symbol C. 5 Type of thermometers Thermometers covered by this Part of EN 12470 are either of the single-use type or the multiple-use type. Thermometers are classified by their measuring range into the following types: a) short scale type with a measuring range of 35,5 C to 40,4 C; b) long sc
31、ale type with a minimum measuring range of 35,5 C to 42,0 C. 6 Requirements 6.1 Scale 6.1.1 Measuring range and scale interval The thermometer shall cover one of the measuring ranges specified in clause 5 with a scale interval no greater than 0,1 C. Testing shall be performed by visual inspection. 6
32、.1.2 Scale marks and numbering Numerals shall be placed at least at every degree graduation on the scale. Testing shall be performed by visual inspection. BS EN 12470-2:2000+A1:2009EN 12470-2:2000+A1:2009 (E) 6 6.1.3 Temperature indication There shall be a distinct difference in appearance before an
33、d after the change of the state of the thermometer dots. Testing shall be performed by visual inspection. 6.2 Measurement retention Any temperature measurement reading of the thermometer shall be maintained for a minimum period of 20 s after the thermometer has been removed from the test site and ha
34、s been allowed to stabilise at room temperature (23 5) C. Testing shall be performed in accordance with 7.2. 6.3 Regeneration The thermometer shall be designed in such a way that if it has been partially or totally activated, it can be returned to functional condition and accuracy by a method specif
35、ied by the manufacturer. Testing shall be performed in accordance with 7.4. 6.4 Effect of storage After testing in accordance with 7.3 the thermometer shall meet the requirements specified in 6.5. 6.5 Maximum permissible error under reference conditions The maximum permissible error shall not exceed
36、 C C + 1 , 0 2 , 0for each individual dot. Testing shall be performed in accordance with 7.2. The temperature difference necessary to activate two adjacent dots shall not exceed 0,2 C. Testing shall be performed in accordance with 7.5. If the thermometer has an offset, the offset shall be uniform th
37、roughout the measuring range of the thermometer. 6.6 Skipped dots The thermometer shall not have two adjacent skipped dots. The total number of skipped dots shall not be greater than 5 % of the total number of dots for that thermometer. Testing shall be performed in accordance with 7.6. 6.7 Thermome
38、ters supplied sterile Thermometers which are labelled “STERILE“ shall comply with EN 556+A1. NOTE Sterilization processes should be validated and routinely controlled. 6.8 Biocompatibility The thermometer shall be free from biological hazard. BS EN 12470-2:2000+A1:2009EN 12470-2:2000+A1:2009 (E) 7 N
39、OTE EN ISO 10993-1 should be used as guidance. 6.9 Measurement time (clinical) for preadjusted thermometers The manufacturer shall demonstrate and document that the specified measurement time conforms to the chosen offset by either: a) compilation and analysis of relevant scientific literature; or b
40、) analysis of data obtained from the result of clinical investigation. 6.10 Additional requirements for multiple-use thermometers Thermometers for multiple use shall be designed to fulfil the requirements of this standard for at least the number of uses specified by the manufacturer after use, clean
41、ing and regeneration as specified by the manufacturer. Testing shall be performed in accordance with 7.7. 6.11 Mechanical safety The temperature probe shall be smoothly rounded in order to prevent tissue damage during use. Testing shall be performed by visual inspection. 7 Test methods 7.1 General E
42、ach 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 not be mixed. The sampling plan shall correspond to ISO 2859-2:1985, level II with a limiting quality level LQ=5%. NOTE
43、1 Other sampling plans can be used if they are statistically equivalent. NOTE 2 For suggested types of testing see Annex A. 7.2 Test of compliance of the maximum permissible error 7.2.1 Apparatus 7.2.1.1 Reference thermometer, with an uncertainty in temperature reading not greater than 0,02 C (cover
44、age 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 of the coverage factor “k” is found in the “Guide to the expression of uncertainty in measurement”. BS EN 12470-2:2000+A1:2009EN 124
45、70-2:2000+A1:2009 (E) 8 7.2.1.2 Reference water bath, well regulated and stirred and containing at least 5 l 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
46、 range of temperature of the thermometer to be tested. It shall have a temperature gradient of not greater than 0,01 C within its working space at a specified temperature. This temperature gradient shall be assured under all conditions and patterns of loadings of thermometer samples. 7.2.2 Procedure
47、 7.2.2.1 Immerse the test thermometer in the water bath (7.2.1.2) for the length of time specified by the manufacturer, and compare the readings obtained to those from the reference thermometer (7.2.1.1). 7.2.2.2 Select a minimum of 20 temperature points representing an even distribution within the
48、measuring range for the test. 7.2.2.3 Measure for each manufacturing lot not less than 10 test thermometers at each specified temperature point. Use every thermometer only once. 7.2.2.4 Move the test thermometers into room temperature of (23 5) C. 7.2.2.5 Perform the reading of the result after equi
49、libration of the test thermometer(s). 7.2.2.6 Read the results 20 s after the first reading to confirm the retention time as specified in 6.2. 7.2.3 Expression of results Calculate the error of the thermometer from the following expression: e = t i- t WBwhere t iis the temperature indicated by the test thermometer; t WBis the temperature of the water bath determined by the reference thermometer. For preadjusted thermometers calculate the error from the following expression: e = t i t o- t WBwhere t oi
