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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12470-3:2000 The Eu
2、ropean Standard EN 12470-3:2000 has the status of a British Standard ICS 11.040.55 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Clinical thermometers Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device This British Stan
3、dard, 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 BS EN 12470-3:2000 Amendments issued since publication Amd. No.DateCo
4、mments National foreword This British Standard is the official English language version of EN 12470-3:2000. The UK participation in its preparation was entrusted by Technical Committee LBI/36, Laboratory glassware and related apparatus, to Subcommittee LBI/36/3, Thermometers, which has the responsib
5、ility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizatio
6、ns represented on this subcommittee 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 C
7、orrespondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does n
8、ot 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. CEN European Committe
9、e for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 2000 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12470-3:2000 E EUROPEAN STANDA
10、RDEN 12470-3 NORME EUROPE ENNE EUROPA ISCHE NORM January 2000 ICS 17.200.20 English version Clinical thermometers Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device Thermome tres me dicaux Partie 3: Performances des thermome tres e lectriques c
11、ompacts (a comparaison et a extrapolation) avec dispositif a maximum Medizinische Thermometer Teil 3: Elecktrische (extrapolierende und nicht extrapolierende) Kompaktthermometer mit Maximumvorrichtung This European Standard was approved by CEN on 13 May 1999. CEN members are bound to comply with the
12、 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
13、 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 Central Secretariat has the same status as the official versi
14、ons. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Page 2 EN 12470-3:2000 BSI 04-2000 1) In preparation.
15、Foreword This European Standard has been prepared by Technical Committee CEN/TC 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 late
16、st 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 rel
17、ationship with EU Directive(s), see informative 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, De
18、nmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. This European Standard applies to clinical thermometers which are used for measuring the body temperature of humans. EN 12470 consists of th
19、e 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 compact electrical thermometers (non-predictive and predictive) with maximum device; Part 4:
20、1)Performance of electrical thermometers for continuous measurements; Part 5:1)Performance of infra-red ear thermometers (with maximum device). Annexes A, B and ZA are informative. Contents Page Foreword2 1Scope3 2Normative references3 3Definitions3 4Unit3 5Types of thermometers3 6Performance requir
21、ements3 7Test methods5 8Information supplied by the manufacturer7 Annex A (informative) Suggested types of testing for the requirements of this standard8 Annex B (informative) Bibliography8 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions
22、 of EU Directives9 Page 3 EN 12470-3:2000 BSI 04-2000 1 Scope This part of EN 12470 specifies the performance requirements for compact clinical electrical thermometers with maximum device (non-predictive and predictive). This European Standard applies to devices that, when taking temperatures, are p
23、owered by an internal power supply and that provide a digital indication of temperature. This European Standard does not apply to clinical electrical thermometers for continuous measurement and thermometers intended to measure skin temperature. 2 Normative references This European Standard incorpora
24、tes by dated or undated reference, provisions from other publications. 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 European
25、 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 manufacturer with medical devices. prEN 12470
26、-1:1998, Clinical thermometers Part 1: Metallic liquid-in-glass thermometers with maximum device. EN 60601-1, Medical electrical equipment Part 1: General requirements for safety. EN 60601-1-2, Medical electrical equipment Part 1: General requirements for safety 2: Collateral Standard Electromagneti
27、c compatibility Requirements and tests. ISO 2859-2:1985, Sampling 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 compact electric
28、al thermometer contact thermometer that consists of a temperature probe and an indicating unit permanently connected together 3.2 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,
29、 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 thermometer that monitors over a required period of time the tempera
30、ture 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 disp
31、lays 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 thermometer, part of which is applied to a body cavity and establishes temperature. It comprises a
32、 temperature sensor with associated parts including coverings, seals, and inner leads when necessary NOTEA body cavity can be the mouth, rectum, armpit or naso-pharynx. 4 Unit The unit of temperature shall be the degree Celsius, symbol 8C. 5 Types of thermometers The types of compact clinical electr
33、ical thermometers 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 thermometer together with the probe cover shall meet the requirements
34、 specified in this standard. Page 4 EN 12470-3:2000 BSI 04-2000 6.2 Metrological requirements 6.2.1 Measuring range The thermometer shall cover the minimum measuring range from 35,5 8C to 42,0 8C. The thermometer shall provide a visual or auditory warning when the measured value of temperature is no
35、t within its specified measuring range. Testing shall be carried out in accordance with 7.2. 6.2.2 Digital increment The digital increment of the indicating unit shall be 0,1 8C or less. Testing shall be performed by visual inspection. 6.2.3 Maximum permissible error under reference conditions The m
36、aximum permissible error for the measuring range 35,5 8C to 42,0 8C shall be 0,1 8C within the ambient temperature range from 18 8C to 28 8C. Outside the measuring range of 35,5 8C to 42,0 8C or outside the ambient temperature range, the maximum permissible error shall not be greater than twice the
37、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; NOTEFor this investigation predictive thermometers can be modified by
38、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 switc
39、hed 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 8C for more than 98 % of the subjects. In the case that the thermometer to be investigated cannot be modified accordingly, it should be compare
40、d 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 (MDD). b) the procedur
41、e for testing in a water bath. 6.2.4 Time response When a non-predictive thermometer at a temperature of (23 2) 8C is immersed into a water bath at (37 1) 8C for 60 s the indicated temperature shall not differ from the reference temperature by more than the maximum permissible error. Testing shall b
42、e performed in accordance with 7.4. 6.2.5 Maximum energy dissipation The indicating unit shall provide an energizing potential sufficiently low so that the energy dissipation (I2R) in the probe shall not cause an increase in indicated temperature by more than 0,01 8C when the probe is immersed in a
43、reference water bath at (37 0,1) 8C. 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) 8C, or for a minimum of 96 h to a temperature of (80 2) 8C, shall be such
44、that the values for maximum permissible 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 8C to +35 8C. When tested in accordance
45、with 7.7, the thermometer shall comply with 6.2.3. 6.3.2 Effect 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,
46、 the thermometer shall comply with 6.2.3. 6.3.5 Electromagnetic compatibility 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 acc
47、ordance with 7.12, the thermometer shall comply with 6.2.3. 6.4 Construction requirements 6.4.1 Functional units 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
48、 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 sha
49、ll 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. Page 5 EN 12470-3:2000 BSI 04-2000 6.4.2 Material The thermometer shall be free from biological hazards. NOTESee EN ISO 10993-1 for the selection of appropriate test met