DIN EN 12470-1-2009 Clinical thermometers - Part 1 Metallic liquid-in-glass thermometers with maximum device(includes Amendment A1 2009) English version of DIN EN 12470-1 2009-11《医.pdf

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1、November 2009DEUTSCHE NORM English price group 13No 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!$Zk“1555672

2、www.din.deDDIN EN 12470-1Clinical thermometers Part 1: Metallic liquid-in-glass thermometers with maximum device(includes Amendment A1:2009)English version of DIN EN 12470-1:2009-11Medizinische Thermometer Teil 1: Mit metallischer Flssigkeit gefllte Glasthermometer mit Maximumvorrichtung(enthlt nder

3、ung A1:2009)Englische Fassung DIN EN 12470-1:2009-11SupersedesDIN EN 12470-1:2000-04See start of validitywww.beuth.deDocument comprises pages27DIN EN 12470-1:2009-11 Start of validity This standard takes effect on 1 November 2009. DIN EN 12470-1:2000-04 may be used in parallel until 21 March 2010. N

4、ational foreword This standard has been prepared 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), Te

5、chnical Committee NA 027-02-18 AA Klinische Thermometer. The DIN Standards corresponding to the International Standards referred to in clause 2 of this document are as follows: ISO 719 DIN ISO 719 ISO 2859-2 DIN ISO 2859-2 Amendments This standard differs from DIN EN 12470-1:2000-04 as follows: a) T

6、he following requirement has been included in subclause 8.1: The manufacturer shall state the date of issue or the latest revision of the instruction for use. b) The following requirement has been included in subclause 8.2: f) the name and address of the authorised representative where the manufactu

7、rer does not have a registered place of business in the community. c) The following requirement has been included in subclause 8.3: f) the name and address of the authorised representative where the manufacturer does not have a registered place of business in the community. d) Annex ZA (informative)

8、 “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC” has been updated in accordance with EU Directive 2007/47/EEC. Previous editions DIN 13100: 1941-10 DIN 13100-1: 1970-05 DIN EN 12470-1: 2000-04 2 DIN EN 12470-1:2009-11 National Annex NA (informat

9、ive) Bibliography DIN ISO 719, Glass Hydrolytic resistance of glass grains at 98 C Method of test and classification DIN ISO 2859-2, Sampling procedures for inspection by attributes Sampling plans indexed by limiting quality (LQ) for isolated lot inspection 3 DIN EN 12470-1:2009-11 4 This page is in

10、tentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12470-1:2000+A1 June 2009 ICS 17.200.20 Supersedes EN 12470-1:2000English Version Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device Thermomtres mdicaux - Partie 1: Thermomtres dilatation de

11、 liquide mtallique dans une gaine de verre, avec dispositif maximum Medizinische Thermometer - Teil 1: Mit metallischer Flssigkeit gefllte Glasthermometer mit Maximumvorrichtung This European Standard was approved by CEN on 13 May 1999 and includes Amendment 1 approved by CEN on 16May 2009. CEN memb

12、ers 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 references concerning such national standards may be obtained on applicati

13、on 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 into its own language and notified to the CEN Management Centre has t

14、he 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portu

15、gal, 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 Brussels 2009 CEN All rights of exploitation in any form and by any means

16、reserved worldwide for CEN national Members. Ref. No. EN 12470-1:2000+A1:2009: EEN 12470-1:2000+A1:2009 (E) 2 Contents Page Foreword 31 Scope 42 Normative references 43 Definitions 44 Unit 55 Types of thermometer .56 Requirements .57 Test methods 88 Information supplied by the manufacturer 14Annex A

17、 (informative) Suggested types of testing for the requirements of this standard . 16Annex B (informative) Advice to be considered for inclusion in the instruction leaflet accompanying mercury-in-glass thermometers . 18Annex C (informative) Bibliography . 19Annex ZA (informative) !Relationship betwee

18、n this European Standard and the Essential Requirements of EU Directive 93/42/EEC“ . 20Annex ZB (informative) A-deviations . 23DIN EN 12470-1:2009-11 EN 12470-1:2000+A1:2009 (E) 3 Foreword This document (EN 12470-1:2000+A1:2009) has been prepared by Technical Committee CEN/TC 205 “Non-active medical

19、 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 conflicting national standards shall be withdrawn at the latest by March 2010

20、. This document includes Amendment 1, approved by CEN on 2009-05-16. This document supersedes EN 12470-1:2000. 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 C

21、ommission 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. For A-deviations, see annex ZB. This European Standard applies to clinical thermomet

22、ers 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) thermometers Part 3: Performance of compac

23、t electrical thermometers (non-predictive and predictive) with maximum device Part 4: Performance of electrical thermometers for continuous measurements Part 5: Performance of infra-red ear thermometers (with maximum device) Annexes A, B, C, ZA and ZB are informative. According to the CEN/CENELEC In

24、ternal 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, Latvia, Lithuania, Luxembourg,

25、Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. DIN EN 12470-1:2009-11 EN 12470-1:2000+A1:2009 (E) 4 1 Scope This Part of EN 12470 specifies performance requirements and test methods for clinical liquid-in-glass thermometers w

26、ith maximum device and applies only to thermometers filled with metallic liquid. NOTE 1 Note that in some European countries the use of mercury is prohibited in clinical thermometers. NOTE 2 Substances other than metallic liquids can be used in the manufacturing of liquid-in-glass thermometers. No r

27、eference is made to these in this European standard because there is no experience of clinical thermometers which use other substances. This European Standard does not apply to clinical thermometers designed for special applications (e.g. thermometers for premature babies, ovulation thermometers) wh

28、ich, owing to their measurement range, scale interval or maximum permissible error, fall outside the scope of 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 approp

29、riate 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 publica

30、tion referred to applies. EN 980, Graphical symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer with medical devices ISO 719, Glass - Hydrolytic resistance of glass grains at 98 degrees C - Method of test and classification ISO 2859-2:1985, Sampling

31、procedures for inspection by attributes Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection 3 Definitions For the purposes of this Part of EN 12470, the following definitions apply: 3.1 correction value added algebraically to the uncorrected result of a measurement to

32、 compensate for systematic error 3.2 error result of measurement minus a true value of the measurand 3.3 maximum device device which prevents the liquid column from falling when the temperature of the liquid in the bulb returns to the ambient temperature 3.4 scale panel (enclosed-scale type) panel t

33、o which the scale is fixed longitudinally behind the capillary tube 3.5 stabilized thermometer reading DIN EN 12470-1:2009-11 EN 12470-1:2000+A1:2009 (E) 5 result given by a thermometer which, after attaining thermal equilibrium with a water bath of a temperature within the thermometers measuring ra

34、nge, has been removed from the water bath and cooled to a temperature of between 15 C and 30 C 3.6 zero point correction correction of the reading of the thermometer at 0 C NOTE K = 0 C -t13.7 zero point depression change of zero point correction after heating and fast cooling of the thermometer 4 U

35、nit The unit of temperature shall be the degree Celsius, symbol C. 5 Types of thermometer The types of metallic liquid-in-glass thermometers with maximum device shall be: a) solid-stem, or b) enclosed-scale 6 Requirements 6.1 Scale 6.1.1 Measuring range and scale interval The thermometer shall cover

36、 the minimum range from 35,5 C to 42,0 C with a scale interval of 0,1 C. Testing shall be performed by visual inspection. 6.1.2 Scale marks and numbering 6.1.2.1 General The scale marks shall be uniformly spaced and of uniform width. The scale marks and numbers shall be at right angles to the axis o

37、f the thermometer and shall be visible at the same time as the liquid column. Testing shall be performed by visual inspection. 6.1.2.2 Scale spacing The distance between adjacent scale marks shall be at least 0,5 mm for solid-stem thermometers and at least 0,6 mm for enclosed-scale thermometers. Tes

38、ting shall be performed using an appropriate device, which magnifies the scale by at least x 4. DIN EN 12470-1:2009-11 EN 12470-1:2000+A1:2009 (E) 6 6.1.2.3 Width and length of the scale marks The scale marks shall be durably marked and shall be of uniform width not exceeding one-quarter of the leng

39、th of a scale spacing plus 0,05 mm for solid-stem thermometers, or one-fifth of the length of a scale spacing plus 0,05 mm for enclosed-scale thermometers. Scale marks representing whole degrees and half degrees shall be longer than the other scale marks. Testing shall be performed using an appropri

40、ate device, which magnifies the scale by at least x 4. 6.1.2.4 Numbering Scale marks representing whole degrees shall be numbered. NOTE The scale mark representing the temperature of 37 C can be rendered conspicuous by means of a different colour from that used for the numbering and/or by additional

41、 marking. Testing shall be performed by visual inspection. 6.1.2.5 Special requirements for solid-stem thermometers The scale shall be indelibly marked directly on the thick-walled capillary stem. When tested in accordance with 7.2, the appearance of the scale lines shall not be significantly affect

42、ed. 6.1.2.6 Special requirements for enclosed-scale thermometers The thermometer shall have a separate scale panel adjacent to the capillary tube. The capillary tube and the scale panel shall be enclosed in a transparent tube impermeably fixed to the bulb and forming a protection sheath. The scale s

43、hall be marked on a scale panel fixed longitudinally behind the capillary tube. Testing shall be performed by visual inspection. 6.1.2.7 Resistance to breakage of enclosed-scale thermometers The thermometer shall not break when subjected to a force of at least 50N in accordance with 7.8. 6.2 Materia

44、l 6.2.1 Thermometer bulb 6.2.1.1 General The thermometer bulb shall be made of a type of glass which satisfies the requirements specified in 6.2.1.2 and 6.2.1.3. This glass shall be clearly and indelibly identified by either: a) an integral mark introduced by the glass manufacturer in such a way as

45、to be clearly recognizable on the bulb after manufacture of the thermometer or; b) by a mark chosen by the glass manufacturer and affixed by the thermometer manufacturer and clearly indicating the type of glass used. DIN EN 12470-1:2009-11 EN 12470-1:2000+A1:2009 (E) 7 6.2.1.2 Hydrolytic resistance

46、When tested in accordance with ISO 719 the quantity of alkali obtained in solution from 1 g of the glass shall not exceed 263,5 g of Na2O. 6.2.1.3 Zero point depression When tested in accordance with the method given in 7.3, the glass shall have an average zero point depression not exceeding 0,05 C.

47、 6.2.2 Maximum device and capillary The glass used for the maximum device and the capillary shall have the same hydrolytic resistance as the glass for the thermometer bulb. 6.2.3 Scale panel of enclosed-scale thermometer The scale panel of enclosed-scale thermometers shall be of opal glass, metal or

48、 another material of a dimensional stability such that, when tested in accordance with 7.4, the length of the scale sample after heating shall not differ from that before heating by more than 0,2 %. 6.2.4 Thermometric liquid filling The metallic liquid filling used in the thermometer shall have the

49、purity, properties and characteristics that will enable the finished thermometers to comply with all requirements specified in this European Standard. The bulb, the capillary tube and the liquid column of the finished thermometer shall be free of gas, water, glass fragments or other foreign material. Testing shall be performed by visual inspection using an appropriate device which magnifies by at least x 4. 6.3 Manufacture 6.3.1 Freedom from defects The thermometer and its surface shall be free