DIN EN 12470-2-2009 en 6013 Clinical thermometers - Part 2 Phase change type (dot matrix) thermometers(includes Amendment A1 2009) English version of DIN EN 12470-2 2009-11《临床体温计 相.pdf

1、November 2009DEUTSCHE NORM English price group 12No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 17.200.20!$ZM“1555842

2、www.din.deDDIN EN 12470-2Clinical thermometers Part 2: Phase change type (dot matrix) thermometers (includes Amendment A1:2009)English version of DIN EN 12470-2:2009-11Medizinische Thermometer Teil 2: Phasenumschlagthermometer (Punktmatrix) (enthlt nderung A1:2009)Englische Fassung DIN EN 12470-2:20

3、09-11SupersedesDIN EN 12470-2:2001-02See start of validitywww.beuth.deDocument comprises pages21DIN EN 12470-2:2009-11 Start of validity This standard takes effect on 1 November 2009. DIN EN 12470-2:2001-02 may be used in parallel until 21 March 2010. National foreword This standard has been prepare

4、d by Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Technical Committee NA 027-02-18 AA Klinische The

5、rmometer. The DIN Standard corresponding to the International Standard referred to in clause 2 of this document is as follows: ISO 2859-2 DIN ISO 2859-2 Amendments This standard differs from DIN EN 12470-2:2001-02 as follows: a) Normative references have been updated. b) The following requirement ha

6、s been included in subclause 8.1: The manufacturer shall state the date of issue or the latest revision of the instruction for use. c) The following requirement has been included in subclause 8.2.1: e) the name and address of the authorised representative where the manufacturer does not have a regis

7、tered place of business in the community. d) The following requirement has been included in subclause 8.2.2: g) the name and address of the authorised representative where the manufacturer does not have a registered place of business in the community. e) The following requirement has been included i

8、n subclause 8.3: k) the name and address of the authorised representative where the manufacturer does not have a registered place of business in the community. f) Annex ZA (informative) “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC” has been up

9、dated in accordance with EU Directive 2007/47/EEC. Previous editions DIN EN 12470-2: 2001-02 2 DIN EN 12470-2:2009-11 National Annex NA (informative) Bibliography DIN ISO 2859-2, Sampling procedures for inspection by attributes Sampling plans indexed by limiting quality (LQ) for isolated lot inspect

10、ion 3 DIN EN 12470-2:2009-11 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12470-2:2000+A1 June 2009 ICS 17.200.20 Supersedes EN 12470-2:2000English Version Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers Thermomtres mdicaux - Par

11、tie 2: Thermomtres changement de phase (matrice points) Medizinische Thermometer - Teil 2: Phasenumschlagthermometer (Punktmatrix) This European Standard was approved by CEN on 16 September 2000 and includes Amendment 1 approved by CEN on 16May 2009. CEN members are bound to comply with the CEN/CENE

12、LEC 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 CEN Management Centre or to any

13、 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 into its own language and notified to the CEN Management Centre has the same status as the official versions.

14、CEN members are the national standards bodies of 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,

15、Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membe

16、rs. Ref. No. EN 12470-2:2000+A1:2009: EEN 12470-2:2000+A1:2009 (E) 2 Contents Page Foreword 31 Scope 42 Normative references 43 Terms and definitions .44 Unit 55 Type of thermometers .56 Requirements .57 Test methods 78 Information supplied by the manufacturer 10Annex A (informative) Suggested types

17、 of testing for the requirements of this standard . 13Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC“ . 15Bibliography . 17DIN EN 12470-2:2009-11 EN 12470-2:2000+A1:2009 (E) 3 Foreword This document (EN 12470-2:2000+A1:200

18、9) 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 the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2009, and con

19、flicting 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 supersedes EN 12470-2:2000. The start and finish of text introduced or altered by amendment is indicated in the text by tags ! “. This European

20、 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 informative Annex ZA, which is an integral part of this standard. This Europ

21、ean Standard applies to clinical thermometers which are used for measuring the body temperature of humans. EN 12470 consists of the following Parts under the general title “Clinical thermometers”: Part 1: Metallic liquid-in-glass thermometers with maximum device Part 2: Phase change type (dot matrix

22、) thermometers Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device Part 4: Performance of electrical thermometers for continuous measurement Part 5: Performance of infra-red ear thermometers (with maximum device) Annexes A and ZA are informative

23、. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy

24、, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. DIN EN 12470-2:2009-11 EN 12470-2:2000+A1:2009 (E) 4 1 Scope This Part of EN 12470 specifies performance requirements and test methods for phase

25、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 does not apply to clinical thermometers designed for special applications (e.g. thermometers for hypothermia) which owing to their measureme

26、nt range, scale interval or maximum permissible error do not meet the requirements specified in this Standard. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publication. These normative references are cited at the appropriate places i

27、n 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

28、to applies (including amendments). EN 980, !Symbols for use in the labelling of medical devices“ EN 1041, Information supplied by the manufacturer with medical devices EN 556+A1, Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled “Sterile“ ISO 28

29、59-2:1985, Sampling procedures for inspection by attributes Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection 3 Terms and definitions For the purposes of this Part of EN 12470, the following terms and definitions apply: 3.1 measurement time length of time required t

30、o measure body temperature 3.2 phase change (dot matrix) thermometer device utilising a change in state of chemical components designed to measure and indicate human body temperature 3.3 retention time duration of time for which the optimal signal for reading persists 3.4 sensor matrix temperature m

31、easuring area consisting of temperature dots NOTE The dots contain different chemical mixtures, which change their state at specific temperatures. This change is accompanied by a change in appearance, e.g. change of colour. When in contact with the temperature site being measured, the change of stat

32、e 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. DIN EN 12470-2:2009-11 EN 12470-2:2000+A1:2009 (E) 5 3.5 temperature offset designed difference between preadjusted thermometer reading and water b

33、ath temperature after reaching thermal equilibrium 3.6 preadjusted thermometer thermometer which is designed to have a temperature offset 3.7 skipped dot a dot which fails to activate when exposed to a temperature which would have caused activation 3.8 adjacent dots dots which are numerically sequen

34、tial 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 Celsius, 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 ty

35、pe. 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 scale 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

36、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. 6.1.2 Scale marks and numbering Numerals shall be placed at least at every degree graduation on the scale. Testing shall be performed by visual

37、inspection. DIN EN 12470-2:2009-11 EN 12470-2:2000+A1:2009 (E) 6 6.1.3 Temperature indication There shall be a distinct difference in appearance before and after the change of the state of the thermometer dots. Testing shall be performed by visual inspection. 6.2 Measurement retention Any temperatur

38、e 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 has been allowed to stabilise at room temperature (23 5) C. Testing shall be performed in accordance with 7.2. 6.3 Regeneration The thermometer shal

39、l 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 specified 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 thermom

40、eter shall meet the requirements specified in 6.5. 6.5 Maximum permissible error under reference conditions The maximum permissible error shall not exceedCC+1,02,0for each individual dot. Testing shall be performed in accordance with 7.2. The temperature difference necessary to activate two adjacent

41、 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 throughout the measuring range of the thermometer. 6.6 Skipped dots The thermometer shall not have two adjacent skipped dots. The total number of skipped dot

42、s 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 Thermometers supplied sterile Thermometers which are labelled “STERILE“ shall comply with EN 556+A1. NOTE Sterilization processes should be validated and routinely

43、 controlled. 6.8 Biocompatibility The thermometer shall be free from biological hazard. DIN EN 12470-2:2009-11 EN 12470-2:2000+A1:2009 (E) 7 NOTE EN ISO 10993-1 should be used as guidance. 6.9 Measurement time (clinical) for preadjusted thermometers The manufacturer shall demonstrate and document th

44、at the specified measurement time conforms to the chosen offset by either: a) compilation and analysis of relevant scientific literature; or b) analysis of data obtained from the result of clinical investigation. 6.10 Additional requirements for multiple-use thermometers Thermometers for multiple us

45、e shall be designed to fulfil the requirements of this standard for at least the number of uses specified by the manufacturer after use, cleaning and regeneration as specified by the manufacturer. Testing shall be performed in accordance with 7.7. 6.11 Mechanical safety The temperature probe shall b

46、e smoothly rounded in order to prevent tissue damage during use. Testing shall be performed by visual inspection. 7 Test methods 7.1 General Each individual lot shall be subjected to testing, either individual or statistical. For statistical testing the lot shall be homogenous and thermometers from

47、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 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 maxi

48、mum permissible error 7.2.1 Apparatus 7.2.1.1 Reference thermometer, with an uncertainty in temperature reading not greater than 0,02 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 d

49、efinition of the coverage factor “k” is found in the “Guide to the expression of uncertainty in measurement”. DIN EN 12470-2:2009-11 EN 12470-2:2000+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 range of temperature of the thermometer to be tested. It shall have a