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1、BRITISH STANDARD BS EN 12470-2:2001 Clinical thermometers Part 2: Phase change type (dot matrix) thermometers The European Standard EN 12470-2:2000 has the status of a British Standard ICS 11.040.55 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun she
2、ffieldun, na, Sat Oct 28 05:28:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 12470-2:2001 This British Standard, 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 1
3、5 June 2001 BSI 06-2001 ISBN 0 580 37670 2 National foreword This British Standard is the official English language version of EN 12470-2:2000. The UK participation in its preparation was entrusted to Technical Committee LBI/36, Laboratory equipment and related glassware, which has the responsibilit
4、y to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Corre
5、spondence 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 no
6、t of itself confer immunity from legal obligations. 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 promul
7、gate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 15 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComme
8、nts Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12470-2 October 2000 ICS 17.200.20 English version Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers Thermomtr
9、es 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 2000. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulat
10、e 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 Management Centre or to any CEN member. This European Standard exists
11、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 Management Centre has the same status as the official versions. CEN members are the national standards bodies o
12、f Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Manag
13、ement Centre: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12470-2:2000 E Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2
14、EN 12470-2:2000 ContentsPage Foreword3 1Scope4 2Normative references4 3Terms and definitions4 4Unit5 5Type of thermometers5 6Requirements5 7Test methods7 8Information supplied by the manufacturer10 Annex A (informative) Suggested types of testing for the requirements of this standard11 Annex ZA (inf
15、ormative) Clauses of this European Standard addressing Essential Requirements or other provisions of EU Directives13 Bibliography15 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 12470-2:2000 Foreword This European Standard has be
16、en 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 latest by April 2001, and conflicting nat
17、ional standards shall be withdrawn at the latest by April 2001. 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 Directive(s), see
18、 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 general title “Clinical thermometers”: Part 1:Metallic liquid-in-
19、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 continuous measurement Part 51Performance of infra-red
20、 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: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germ
21、any, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. 1 In preparation Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 12470-2:2000 1Scope This Part of E
22、N 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 does not apply to clinical thermometers designed for special applicat
23、ions (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. 2Normative references This European Standard incorporates by dated or undated reference, provisions from other publica
24、tion. 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 Standard only when incorporated in it by amendment or revision.
25、For undated references the latest edition of the publication referred to applies (including amendments). EN 980Graphical symbols for use in the labelling of medical devices EN 1041Information supplied by the manufacturer with medical devices EN 556+A1Sterilization of medical devices - Requirements f
26、or terminally-sterilized medical devices to be labelled “Sterile“ ISO 2859-2:1985Sampling procedures for inspection by attributes - Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection 3Terms and definitions For the purposes of this Part of EN 12470, the following term
27、s 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 human body temperature. 3.3 retention time duration of time for whic
28、h 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 is accompanied by a change in appearance, e. g. change of colour.
29、 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. 3.5 temperature offset designed difference between preadjusted thermom
30、eter reading and water bath temperature after reaching thermal equilibrium. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 12470-2:2000 3.6 preadjusted thermometer thermometer which is designed to have a temperature offset. 3.7 sk
31、ipped 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 sequential according to the scale. 3.9 storage package smallest original shipping unit used by the manufacturer. 4Unit The unit of temperature shall
32、be the degree Celsius, symbol C. 5Type 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
33、 C; b) long scale type with a minimum measuring range of 35,5 C to 42,0 C. 6Requirements 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
34、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 inspection. 6.1.3 Temperature indication There shall be a distinct difference in appearance before and after the change of the state of the ther
35、mometer 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 has been allowed to stabilise at room tempera
36、ture (23 5) C. Testing shall be performed in accordance with 7.2. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 6 EN 12470-2:2000 6.3 Regeneration The thermometer shall be designed in such a way that if it has been partially or totall
37、y 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 thermometer shall meet the requirements specified in 6.5. 6.5 Maximum perm
38、issible error under reference conditions The maximum permissible error shall not exceed C, C, ? ? 10 20 for 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
39、 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 dots shall not be greater than 5 % of the total number of dots
40、 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 controlled. 6.8 Biocompatibility The thermometer shall be
41、 free from biological hazard. NOTE: 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 with the chosen offset by either : a) compilation and analysis of r
42、elevant 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 use shall be designed to fulfil the requirements of this standard for at least the number of uses specified b
43、y 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 be smoothly rounded in order to prevent tissue damage during use. Licensed Copy: sheffieldun sheffieldun, na
44、, Sat Oct 28 05:28:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 7 EN 12470-2:2000 Testing shall be performed by visual inspection. 7Test methods 7.1 General Each individual lot shall be subjected to testing, either individual or statistical. For statistical testing the lot shall be homogenous
45、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 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 o
46、f 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 (coverage factor k=2) shall be used to determine the temperature of the water bath. Its calibration shall be traceable to national measureme
47、nt standards. NOTE: The definition of the coverage factor “k” is found in the “Guide to the expression of uncertainty in measurement”. 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 r
48、ange. 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 temperature gradient of not greater than 0,01 C within its working space at a specified temperature. This temperature
49、gradient shall be assured under all conditions and patterns of loadings of thermometer samples. 7.2.2 Procedure 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 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
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