1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12470-1:2000 ICS 11
2、.040.55 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Clinical thermometers Part 1: Metallic liquid-in-glass thermometers with maximum device +A1:2009National foreword This British Standard is the UK implementation of EN 12470-1:2000+A1:2009. It supersedes BS EN 12470-1:2000
3、, which is withdrawn.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 in its preparation
4、 was entrusted by Technical Committee LBI/36, Laboratory glassware and related apparatus, to Subcommittee LBI/36/3, Thermometers. A list of organizations represented on this subcommittee can be obtained on request to its secretary. This publication does not purport to include all the necessary provi
5、sions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. BS EN 12470-1:2000+A1:2009 This British Standard was published under the authority of the Strategy Committee and comes into effect on 15 April 200
6、0 BSI 2009 Amendments/corrigenda issued since publication Date Comments 31 August 2009 Implementation of CEN amendment A1:2009 ISBN 978 0 580 65151 9 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12470-1:2000+A1 June 2009 ICS 17.200.20 Supersedes EN 12470-1:2000 English Version Clinical therm
7、ometers - Part 1: Metallic liquid-in-glass thermometers with maximum device Thermomtres mdicaux - Partie 1: Thermomtres dilatation de liquide mtallique dans une gaine de verre, avec dispositif maximum Medizinische Thermometer - Teil 1: Mit metallischer Flssigkeit gefllte Glasthermometer mit Maximumv
8、orrichtung This European Standard was approved by CEN on 13 May 1999 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 wi
9、thout 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 CEN member. This European Standard exists in three official versions (English, French, German). A version in any other langua
10、ge 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. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland
11、, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, 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 KOMI
12、TEE 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 Members. Ref. No. EN 12470-1:2000+A1:2009: EEN 12470-1:2000+A1:2009 (E) 2 Contents Page Foreword 3 1 Scope 4 2 Normative references
13、 4 3 Definitions 4 4 Unit 5 5 Types of thermometer .5 6 Requirements .5 7 Test methods 8 8 Information supplied by the manufacturer 14 Annex A (informative) Suggested types of testing for the requirements of this standard . 16 Annex B (informative) Advice to be considered for inclusion in the instru
14、ction leaflet accompanying mercury-in-glass thermometers . 18 Annex C (informative) Bibliography . 19 Annex ZA (informative) ! ! ! !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC“ “ “ “ . 20 Annex ZB (informative) A-deviations . 23 BS EN 12470-1:
15、2000+A1:2009EN 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 devices“, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by pu
16、blication 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 supersedes EN 12470-1:2000. The start and finish of te
17、xt 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 EU Directive(s). For relationship with EU Direc
18、tive(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 thermometers which are used for measuring the body temperature of humans. EN 12470 consists of the following Parts under the general title Clinica
19、l 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 thermometers for continuo
20、us 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 Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austri
21、a, 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 12470-1:2
22、000+A1:2009EN 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 with maximum device and applies only to thermometers filled with metallic liquid. NOTE 1 Note that in some European countries the use o
23、f 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 reference is made to these in this European standard because there is no experience of clinical thermometers which use other substances
24、. This European Standard does not apply to clinical thermometers designed for special applications (e.g. thermometers for premature babies, ovulation thermometers) which, owing to their measurement range, scale interval or maximum permissible error, fall outside the scope of this standard. 2 Normati
25、ve references This European Standard incorporates 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
26、 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 for use in the labelling of medical devices EN 1041, Information supplied by the m
27、anufacturer 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 procedures for inspection by attributes Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection 3 Definiti
28、ons 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 compensate for systematic error 3.2 error result of measurement minus a true value of the measurand 3.3 maximum device device which p
29、revents 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 to which the scale is fixed longitudinally behind the capillary tube 3.5 stabilized thermometer reading BS EN 12470-1:2000+A1:2009EN 12
30、470-1:2000+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 range, 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
31、 of the reading of the thermometer at 0 C NOTE K = 0 C -t 1 3.7 zero point depression change of zero point correction after heating and fast cooling of the thermometer 4 Unit The unit of temperature shall be the degree Celsius, symbol C. 5 Types of thermometer The types of metallic liquid-in-glass t
32、hermometers 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 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 S
33、cale 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 of the thermometer and shall be visible at the same time as the liquid column. Testing shall be performed by visual inspection. 6.
34、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. Testing shall be performed using an appropriate device, which magnifies the scale by at least x 4. BS EN 12470-1:2000+A1:2009EN 1247
35、0-1:2000+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 length 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
36、 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 appropriate device, which magnifies the scale by at least x 4. 6.1.2.4 Numbering Scale marks representing whole degrees shall be numbe
37、red. 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 marking. Testing shall be performed by visual inspection. 6.1.2.5 Special requirements for solid-stem thermometers The scale
38、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 affected. 6.1.2.6 Special requirements for enclosed-scale thermometers The thermometer shall have a separate scale panel adjacent to
39、 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 shall be marked on a scale panel fixed longitudinally behind the capillary tube. Testing shall be performed by visual inspectio
40、n. 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 Material 6.2.1 Thermometer bulb 6.2.1.1 General The thermometer bulb shall be made of a type of glass which satisfies the requirement
41、s 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 to be clearly recognizable on the bulb after manufacture of the thermometer or; b) by a mark chosen by the glass manufacturer
42、and affixed by the thermometer manufacturer and clearly indicating the type of glass used. BS EN 12470-1:2000+A1:2009EN 12470-1:2000+A1:2009 (E) 7 6.2.1.2 Hydrolytic resistance When tested in accordance with ISO 719 the quantity of alkali obtained in solution from 1 g of the glass shall not exceed 2
43、63,5 g of Na 2 O. 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. 6.2.2 Maximum device and capillary The glass used for the maximum device and the capillary shall have the same hydrolyti
44、c 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 another material of a dimensional stability such that, when tested in accordance with 7.4, the length of the scale sampl
45、e 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 purity, properties and characteristics that will enable the finished thermometers to comply with all requirements specifi
46、ed 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 Manufa
47、cture 6.3.1 Freedom from defects The thermometer and its surface shall be free from defects that are likely to interfere with its proper functioning or to mislead the user, e.g. errors in graduation, flaws in the glass and constructional defects. Testing shall be performed with an appropriate device
48、, which magnifies the scale by at least x 4. 6.3.2 Capillary tube The capillary tube shall ensure that the entire length of the liquid column and the meniscus are clearly visible from at least one angle. It shall be prismatic in form and have a magnifying effect, or shall be so designed as to ensure
49、 consistent ease of reading. Testing shall be performed by visual inspection. 6.3.3 Thermometer ends The ends of the thermometer shall be smoothly rounded in order to prevent tissue damage during use. Testing shall be performed by visual and tactile inspection. BS EN 12470-1:2000+A1:2009EN 12470-1:2000+A1:2009 (E) 8 6.3.4 Liquid column When the thermometer is heated slowly, the liquid column shall rise uniformly without appreciable surges. NOTE Surges larger than half a scale interval are con
