EN ISO 80601-2-56-2017 en Medical electrical equipment - Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature .pdf

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1、Medical electrical equipmentPart 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017)BS EN ISO 80601-2-56:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN

2、STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80601-2-56 July 2017 ICS 11.040.55 Supersedes EN ISO 80601-2-56:2012English Version Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (

3、ISO 80601-2-56:2017) Appareils lectromdicaux - Partie 2-56: Exigences particulires relatives la scurit fondamentale et aux performances essentielles des thermomtres mdicaux pour mesurer la temprature de corps (ISO 80601-2-56:2017) Medizinische elektrische Gerte - Teil 2-56: Besondere Festlegungen fr

4、 die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Krpertemperatur (ISO 80601-2-56:2017) This European Standard was approved by CEN on 28 June 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate t

5、he 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-CENELEC Management Centre or to any CEN member. This European Standar

6、d 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-CENELEC Management Centre has the same status as the official versions. CEN members are the nation

7、al standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbi

8、a, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by a

9、ny means reserved worldwide for CEN national Members. Ref. No. EN ISO 80601-2-56:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 80601-2-56:2017. It is identical to ISO 80601-2-56:2017. It supersedes BS EN ISO 80601-2-56:2012, which is withdrawn.The UK participation i

10、n its preparation was entrusted to Technical Committee CH/121/9, Lung Ventilators deletion of Annex CC as this mat erial is covered by IEC 60601191; and the following additions: disclosure requirement for a summary of the USE SPECIFICATION; tests for mechanical strength (via IEC 60601111 and IEC 606

11、 01112); tests for ENCLOSURE integrity (water ingress via IEC 60601111 and IEC 60601112); tests for cleaning and disinfection PROCEDURES (via IEC 60601111 and IEC 60601112). BS EN ISO 80601-2-56:2017ISO 80601-2-56:2017(E) vi ISO 2017 All rights reservedIntroduction This document deals with electrica

12、l CLINICAL THERMOMETERS, either already available or that will come available in the future. The purpose of a CLINICAL THERMOMETER is to assess the true temperature of a REFERENCE BODY SITE. The temperature of the PATIENTS body is an important vital sign in assessing overall health, typically in com

13、bination with blood pressure and pulse rate. Determining whether a PATIENT is afebrile, febrile or hypothermic is an important purpose of a CLINICAL THERMOMETER, since being febrile suggests that the PATIENT is ill. There are different temperatures at each REFERENCE BODY SITE according to the balanc

14、e between the production, transfer, and loss of heat2. CLINICAL ACCURACY of a CLINICAL THERMOMETER is VERIFIED by comparing its OUTPUT TEMPERATURE with that of a REFERENCE THERMOMETER, which has a specified uncertainty for measuring true temperature. For an equilibrium CLINICAL THERMOMETER, the CLIN

15、ICAL ACCURACY can be sufficiently determined under laboratory conditions that create an equilibrium state between the two thermometers. For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, laboratory VERIFICATION alone is not sufficient because the adjustment algorithm for deriving the OUT

16、PUT TEMPERATURE includes the characteristics of the PATIENT and the environment3. Therefore, the CLINICAL ACCURACY of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE has to be VALIDATED clinically, using statistical methods of comparing its OUTPUT TEMPERATURE with that of a REFERENCE CLINI

17、CAL THERMOMETER which has a specified CLINICAL ACCURACY in representing a particular REFERENCE BODY SITE temperature. For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, the LABORATORY ACCURACY is VERIFIED in a DIRECT MODE and the CLINICAL ACCURACY is VALIDATED in the ADJUSTED MODE (OPERA

18、TING MODE) with a sufficiently large group of human subjects. The intention of this document is to specify the requirements and the test PROCEDURES for the VERIFICATION of the LABORATORY ACCURACY for all types of electrical CLINICAL THERMOMETERS as well as for the VALIDATION of the CLINICAL ACCURACY

19、 of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE. This document has been drafted in accordance with the ISO/IEC Directives, Part 2. In this document, the following print types are used. Requirements and definitions: roman type. Test specifications: italic type. Informative material appe

20、aring outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. T ERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS. In referring to the structure of this document, the term “clause” me

21、ans one of the numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.), and “subclause” means a numbered subdivision of a clause (e.g. 7. 1, 7.2 and 7.2.1 are all subclauses of Clause 7). BS EN ISO 80601-2-56:2017ISO 80601-2-5

22、6:2017(E) ISO 2017 All rights reserved viiReferences to clauses within this document are preceded by the term “Clause” followed by the clause number. References to subclauses within this document are by number only. In this document, the conjunctive “or” is used as an “inclusive or” so a statement i

23、s true if any combination of the conditions is true. The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for comp

24、liance with this document; “should” means that compliance with a requirement or a test i s recommended but is not mandatory for compliance with this document; “may” is used to describe a permissible way to achieve compli ance with a requirement or test. An asterisk (*) as the first character of a ti

25、tle or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period foll

26、owing publication of a new, amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committees that the content of this publication be adopted for implemen

27、tation nationally not earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. BS EN ISO 80601-2-56:2017BS EN ISO 80601-2-56:2017 ISO 2017 All rights reserved 1Medical electrical equi

28、pment Part 256: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement 201.1 * Scope, object and related standards IEC 606011:2005+A1:2012, Clause 1 applies, except as follows: 201.1.1 Scope Replacement: This document applies to t

29、he BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This document specifies the general and technical requirements for electrical CLINICAL THERMOMETERS. This document applies to all electrical CLINICAL THERMO

30、METERS that are used for measuring the BODY TEMPERATURE of PATIENTS. CLINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME SYSTEMS. This document does not apply to auxiliary equipment. ME EQUIPMENT th

31、at measures a BODY TEMPERATURE is inside the scope of this document. This document does not specify the requirements for screening thermographs intended to be used for the individual noninvasive human febrile temperature screening of groups of individual humans under indoor environmental conditions,

32、 which are given in IEC 806012594. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SY

33、STEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 606011:2005+A1:2012, 7.2.13 and 8.4.1. NOTE Additional information can be found in IEC 6

34、06011:2005+A1:2012, 4.2. 201.1.2 Object Replacement: The object of this particular document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for a CLINICAL THERMOMETER, as defined in 201.3.206, and its ACCESSORIES. NOTE ACCESSORIES are included because the combination o

35、f the CLINICAL THERMOMETER and the ACCESSORIES needs to be safe and effective. ACCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER. INTERNATIONAL STANDARD ISO 80601-2-56:2017(E)BS EN ISO 80601-2-56:2017ISO 80601-2-56:2017(E) 2 ISO 2017 Al

36、l rights reserved201.1.3 Collateral standards Addition: This document refers to those applicable collateral standards that are listed in IEC 606011:2005+A1:2012, Clause 2, as well as 201.2 of this document. IEC 6060112, IEC 6060116, IEC 6060118, IEC 60601111 and IEC 60601112 apply as modified in Cla

37、uses 202, 206, 208, 211 and 212, respectively. IEC 60601135does not apply. All other published collateral standards in the IEC 606011 series apply as published. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements containe

38、d in the general standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a document takes priority over IEC 606011 and its collateral standards. For brevity, IEC 606011:2005+A1:2012 is referr

39、ed to in this document as the general standard. Collateral standards are referred to by their document number. The numbering of sections, clauses and subclauses of this document corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Cl

40、ause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of the 6060112 collateral standard, 203.4 in this document addresses the con

41、tent of Clause 4 of the 6060113 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the IEC 606011 or applicable collateral standard is replaced completely by the text of this

42、 particular document. “Addition” means that the text of this document is additional to the requirements of the IEC 606011 or applicable collateral standard. “Amendment” means that the clause or subclause of the IEC 606011 or applicable collateral standard is amended as indicated by the text of this

43、document. Subclauses or figures which are additional to those of the general standard are numbered starting from 201.101, Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses or figures which are additional to those of a collateral standard are numbered starti

44、ng from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 6060112, 203 for IEC 6060113, etc. The term “this document” is used to make reference to the IEC 606011:2005+A1:2012, any applicable collateral standards and this document taken together. Where there is no correspondin

45、g section, clause or subclause in this document, the section, clause or subclause of the IEC 606011 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the IEC 606011 or applicable collateral standard, although possib

46、ly relevant, is not to be applied, a statement to that effect is given in this document. BS EN ISO 80601-2-56:2017ISO 80601-2-56:2017(E) ISO 2017 All rights reserved 3201.2 Normative references The following documents are referred to in the text in such a way that some or all of their content consti

47、tutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 606011:2005+A1:2012, Clause 2 applies, except as follows: Replacement: IEC 6060112:2014, Medical el

48、ectrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances Requirements and tests IEC 6060116:2010, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral St

49、andard: Usability +Amendment 1:2013IEC 6060118:2006, Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems +Amendment 1:2012Addition: ISO 14155:2011, Clinical investigation of medical devices for human subjects Good clinical practice ISO 14937:2009,