EN ISO 80601-2-56:2012

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Körpertemperatur (ISO 80601-2-56:2009)Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles des thermomètres médicaux pour mesurer la température de corps (ISO 80601-2-56:2009)Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 80601-2-56:2012SIST EN ISO 80601-2-56:2013en01-januar-2013SIST EN ISO 80601-2-56:2013SLOVENSKI
STANDARDSIST EN 12470-5:2003SIST EN 12470-4:2001+A1:2009SIST EN 12470-3:2000+A1:20091DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 80601-2-56
October 2012 ICS 11.040.55 Supersedes EN 12470-3:2000+A1:2009, EN 12470-4:2000+A1:2009, EN 12470-5:2003English Version
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles des thermomètres médicaux pour mesurer la température de corps (ISO 80601-2-56:2009)
Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Körpertemperatur (ISO 80601-2-56:2009) This European Standard was approved by CEN on 16 September 2012.
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 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 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-CENELEC Management Centre has the same status as the official versions.
CEN members are the national 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 80601-2-56:2012: ESIST EN ISO 80601-2-56:2013

Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .4 SIST EN ISO 80601-2-56:2013

Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this International standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 201.11 7.2 Only the parts of ER 7.2 relating to safety in use for the patient are addressed. 201.11 7.3 Only the part of the first sentence relating to design is addressed. 201.7.9.2.14.101 7.5 Only the third paragraph of ER 7.5 is addressed. 201.11, 201.103 7.6
201.11 8.1 The part of ER 8.1 relating to easy handling is not addressed. 201.11 8.4 Validated processes for sterilization are required via the normative references to ISO 11134, ISO 11135, ISO 11137. 201.7.2.1.101 8.7
201.4, 201.4.2.101, 201.7, 201.7.9.2.101 e), 201.16, 201.101.1, 201.102.1, 201.103, 201.103.2 9.1
201.9, 201.12.1.101, 201.12.2, 201.15, 202 9.2 The 4th indent of ER 9.2 is not addressed. 201.11, 201.13 9.3
201.7.9.2.101 d), 201.12, 201.101, 201.102, 201.103 10.1
201.12.2 10.2
201.7 10.3
201.14 12.1
201.14 12.1 a)
201.12 12.4
202 12.5
201.8 12.6
201.9 12.7.1
201.9 12.7.2
201.9 12.7.3
201.8, 201.11, 201.15 12.7.4
201.11, 201.15 12.7.5
201.7, 201.12.2, 201.15, 206 12.9
201.7, 201.7.2.1, 201.7.2.1.101, 201.7.2.2, 201.7.9 13.1 The requirement for information on the sales packaging is not addressed. 201.7, 201.7.2.1, 201.8, 201.9 13.2
201.7, 201.7.9.1 13.3 a)
201.7, 201.7.2.1.101 b) 13.3 b)
201.7.2.1.101 c) 13.3 c)
201.7 13.3 d) This ER is only covered if the batch number is preceded by the word LOT. 201.7.2.1.101 d) 13.3 e)
201.7.2.1.101, 201.7.2.1.101 e) 13.3 f)
201.7, 201.7.2.1.101 f) 13.3 i)
201.7 13.3 j)
201.7 13.3 k)
201.7.2.1.101 c) 13.3 m) Presumption of conformity is only provided if symbols 4 to 7 are utilized. 201.7, 201.7.9.1, 201.16 13.6 a)
201.7.9.2.101 c), 201.7.9.2.101 d) 13.6 b)
201.7, 201.7.9.2.101 e), 201.16 13.6 c)
201.7, 201.7.9.2.101 g), 201.16 13.6 d)
201.7, 201.16 13.6 f)
201.7, 201.7.2.9.2.101 j), 201.11, 201.16 13.6 h) The requirement for information on the packaging is not addressed. SIST EN ISO 80601-2-56:2013

201.7.2.9.2.101 i) 13.6 n)
201.7.2.9.2.101 d) 13.6 p)
201.7.2.9.2.101 k) 13.6 q)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. SIST EN ISO 80601-2-56:2013

Reference numberISO 80601-2-56:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO80601-2-56First edition2009-10-01Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Appareils électromédicaux — Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux perfomances essentielles des thermomètres médicaux pour mesurer la température de corps SIST EN ISO 80601-2-56:2013

ISO 80601-2-56:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
©
ISO 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
+ 41 22 749 01 11 Fax
+ 41 22 749 09 47 E-mail
copyright@iso.org Web
www.iso.org Published in Switzerland
ii © ISO 2009 – All rights reserved
ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved iii Contents Page Foreword.v Introduction.vi 201.1 * Scope, object and related standards.1 201.1. 1 Scope.1 201.1. 2 Object.2 201.1. 3 Collateral standards.2 201.1. 4 Particular standards.2 201.2 Normative references.3 201.3 Terminology and definitions.3 201.4 General requirements.6 201.4. 2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS.6 201.4. 2.101 Additional requirements for RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS.7 201.4. 3 ESSENTIAL PERFORMANCE.7 201.4. 3.101 * Additional requirements for ESSENTIAL PERFORMANCE.7 201.4. 101 Environmental conditions of use.7 201.5 General requirements for testing of ME EQUIPMENT.7 201.6 Classification of ME EQUIPMENT and ME SYSTEMS.7 201.7 ME EQUIPMENT identification, marking and documents.7 201.7. 2.1 Minimum requirements for marking on ME EQUIPMENT and interchangeable parts.8 201.7. 2.1.101 Additional requirements for minimum requirements for marking on ME EQUIPMENT and interchangeable parts, marking of the packaging.8 201.7. 2.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts.8 201.7. 2.101 Additional requirements for marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts.8 201.7. 4.3 Unit of measure.8 201.7. 4.3.101 Additional requirements for unit of measure.8 201.7. 9 ACCOMPANYING DOCUMENT.9 201.7. 9.1 Additional general requirements.9 201.7. 9.2 Additional requirements for instructions for use.9 201.7. 9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment, used material.9 201.7. 9.2.101 Instructions for use.9 201.7. 9.101 Additional requirements for ACCOMPANYING DOCUMENT.10 201.8 Protection against electrical HAZARDS from ME EQUIPMENT.10 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS.10 201.10 Protection against unwanted and excessive radiation HAZARDs.10 201.11 Protection against excessive temperatures and other HAZARDS.10 201.12 Accuracy of controls and instruments and protection against hazardous outputs.10 201.12. 1 Accuracy of controls and instruments.10 201.12. 1.101 Additional requirements for accuracy of controls and instruments.10 201.12. 2 USABILITY.11 201.12. 2.101 * Additional requirements for USABILITY.11 201.13 HAZARDOUS SITUATIONS and fault conditions.11 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).11 SIST EN ISO 80601-2-56:2013

ISO 80601-2-56:2009(E) iv © ISO 2009 – All rights reserved 201.15 Construction of ME EQUIPMENT.11 201.16 ME SYSTEMS.11 201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.11 201.101 Laboratory performance requirements.11 201.101. 1 * General test requirements.11 201.101. 2 * Laboratory accuracy.12 201.101. 3 * Time response for a continuous clinical thermometer.13 201.102 * Clinical accuracy validation.13 201.102. 1 Method.13 201.102. 2 * Human subject population requirements.14 201.102. 3 * Clinical bias calculation.15 201.102. 4 * Limits of agreement calculation.15 201.102. 5 * Clinical repeatability calculation.16 201.103 * Probes, probe cable extenders and probe covers.16 201.103. 1 General.16 201.103. 2 Labeling.17 202 Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests.17 202.6.2.1.10 Compliance criteria.17 Annexes Annex C (informative)
Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.19 Annex D (informative)
Symbols on Marking.22 Annex AA (informative)
Particular Guidance and rationale.24 Annex BB (informative)
REFERENCE TEMPERATURE SOURCE.37 Annex CC (informative)
Environmental aspects.39 Annex DD (informative)
Reference to the essential principles of safety and performance of medical devices in accordance with ISO/TR 16142.40 Bibliography.42 Alphabetized index of defined terms used in this particular standard.45
ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved v Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 80601-2-56 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in cooperation with Subcommittee 62D, Electrical equipment, of Technical Committee IEC/TC 62: Electrical equipment in medical practice. ISO 80601 consists of the following parts, under the general title Medical electrical equipment: ⎯ Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators ⎯ Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation ⎯ Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors ⎯ Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement ⎯ Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use IEC 80601-2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers, IEC 80601-2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses intended for heating in medical use, IEC 80601-2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery, IEC 80601-2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening and IEC 80601-2-60: Particular requirements for basic safety and essential performance of dental equipment are published by IEC. SIST EN ISO 80601-2-56:2013

ISO 80601-2-56:2009(E) vi © ISO 2009 – All rights reserved Introduction In this International Standard, the following print types are used. ⎯ Requirements and definitions: roman type. ⎯ Test specifications: italic type. ⎯ Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. ⎯ TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this International Standard, the term ⎯ “clause” means one of the 20 numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); ⎯ “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this International Standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this International Standard are by number only. In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this International Standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this International Standard, the auxiliary verb: ⎯ “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; ⎯ “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; ⎯ “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. This international standard deals with electrical 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 PATIENT'S body is an important vital sign in assessing overall health, typically in combination with blood pressure and pulse rate. Determining whether a PATIENT is afebrile or febrile is an important purpose of a CLINICAL THERMOMETER, since being febrile suggests that the PATIENT is ill. SIST EN ISO 80601-2-56:2013

ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved vii There are different temperatures at each REFERENCE BODY SITE according to the balance between the production, transfer, and loss of heat.[38] 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 CLINICAL 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 OUTPUT TEMPERATURE includes the characteristics of the PATIENT and the environment.[3] 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 CLINICAL 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 (OPERATING MODE) with a sufficiently large group of human subjects. The intention of this International Standard 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 of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE.
INTERNATIONAL STANDARD ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved 1 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement 201.1 * Scope, object and related standards IEC 60601-1:2005, Clause 1 applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This standard specifies the general and technical requirements for electrical CLINICAL THERMOMETERS. This standard applies to all electrical CLINICAL THERMOMETERS 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 standard does not apply to auxiliary equipment. ME EQUIPMENT that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of this standard. EXAMPLE 1 Swan-Ganz thermodilution determination of cardiac output is not in the scope of this standard. EXAMPLE 2 A Foley catheter that includes a temperature PROBE is in the scope of this standard. EXAMPLE 3 PATIENT heating ME EQUIPMENT that includes a skin temperature measurement such as infant incubators, heating blankets, heating pads and heating mattresses are not in the scope of this standard, unless they indicate a temperature of a REFERENCE BODY SITE in which they are in the scope of this standard. Requirements for ME EQUIPMENT intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601-2-59:2008 and such ME EQUIPMENT is not covered by this standard. 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 SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in IEC 60601-1:2005, 7.2.13 and 8.4.1. NOTE
Additional information can be found in IEC 60601-1:2005, 4.2. SIST EN ISO 80601-2-56:2013

ISO 80601-2-56:2009(E) 2 © ISO 2009 – All rights reserved 201.1.2 Object Replacement: The object of this particular standard 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 of the CLINICAL THERMOMETER and the ACCESSORIES needs to be safe. ACCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in IEC 60601-1:2005, Clause 2, as well as Clause 2 of this particular standard. IEC 60601-1-3 does not apply. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained 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 particular standard takes priority over IEC 60601-1. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of sections, clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 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 particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 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 60601-1 or applicable collateral standard is replaced completely by the text of this particular standard. “Addition” means that the text of this particular standard is additional to the requirements of the IEC 60601-1 or applicable collateral standard. “Amendment” means that the clause or subclause of the IEC 60601-1 or applicable collateral standard is amended as indicated by the text of this particular standard. 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 starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 6060-1-3, etc. The term “this standard” is used to make reference to the IEC 60601-1, any applicable collateral standards and this particular standard taken together. SIST EN ISO 80601-2-56:2013

ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved 3 Where there is no corresponding section, clause or subclause in this particular standard, the section, clause or subclause of the IEC 60601-1 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the IEC 60601-1 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard. 201.2 Normative references NOTE Informative references are listed in the bibliography beginning on page 43. IEC 60601-1:2005, Clause 2 applies, except as follows: Replacement: IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic compatibility — Requirements and tests IEC 60601-1-6:2006, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral Standard: Usability IEC 60601-1-8:2006, 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 Addition: ISO 14155-1:2003, Clinical investigation of medical devices for human subjects — Part 1: General requirements ISO 14155-2:2003, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements Amendment 1:2008 IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance IEC 60601-1-9:2007, Medical electrical equipment — Part 1-9: General requirements for basic safety and essential performance — Collateral Standard: Requirements for environmentally conscious design IEC 60601-1-10:2007, Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop controllers 201.3 Terminology and definitions For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, IEC 60601-1-6:2006, IEC 60601-1-8:2006, and the following definitions apply. NOTE An alphabetized index of defined terms is found beginning on page 45. Additions: 201.3.201 * ADJUSTED MODE OPERATING MODE where the OUTPUT TEMPERATURE is calculated by adjusting the signal from the input SENSOR SIST EN ISO 80601-2-56:2013

ISO 80601-2-56:2009(E) 4 © ISO 2009 – All rights reserved EXAMPLE Adjustments can include one or more of the following: variations in the SENSOR'S rate of response, ambient temperature, measured temperature, and the thermal, physiological, or anatomical properties of both the MEASURING SITE and the REFERENCE BODY SITE. NOTE For the purposes of this particular standard, emissivity is considered a thermal or physiological property of the MEASURING SITE, i.e. any CLINICAL THERMOMETER utilizing radiance that is dependant on emissivity is considered to operate in an ADJUSTED MODE. 201.3.202 BLACKBODY REFERENCE TEMPERATURE SOURCE of infrared radiation made in the shape of a cavity and characterized by precisely known temperature of the cavity walls and having an effective emissivity at the cavity opening as close as practical to unity 201.3.203 CLINICAL ACCURACY closeness of agreement between the OUTPUT TEMPERATURE of a CLINICAL THERMOMETER and the true value of the temperature of the REFERENCE BODY SITE that the CLINICAL THERMOMETER purports to represent 201.3.204 CLINICAL BIAS ∆cb mean difference between OUTPUT TEMPERATURES of a CLINICAL THERMOMETER and a REFERENCE CLINICAL THERMOMETER for the intended REFERENCE BODY SITE with specified LIMITS OF AGREEMENT when measured from selected group of subjects NOTE LIMITS OF AGREEMENT can also be described as clinical uncertainty. 201.3.205 CLINICAL REPEATABILITY σr pooled standard deviation (over a selected group of subjects) of changes in multiple OUTPUT TEMPERATURES taken from the same subject from the same MEASURING SITE with the same CLINICAL THERMOMETER by the same OPERATOR within a relatively short time 201.3.206 * CLINICAL THERMOMETER ME EQUIPMENT used for measuring at the MEASURING SITE and indicating the temperature at the REFERENCE BODY SITE NOTE The MEASURING SITE can be the same as REFERENCE BODY SITE. 201.3.207 * DIRECT MODE OPERATING MODE of a CLINICAL THERMOMETER where the OUTPUT TEMPERATURE is an unadjusted temperature that represents the temperature of the MEASURING SITE to which the PROBE is coupled 201.3.208 EXTENDED OUTPUT RANGE OUTPUT TEMPERATURE range having one or both limits that are outside of the RATED OUTPUT RANGE 201.3.209 FLUID BATH REFERENCE TEMPERATURE SOURCE containing fluid at a uniform temperature EXAMPLES Water, oil and air. SIST EN ISO 80601-2-56:2013

ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved 5 201.3.210 LABORATORY ACCURACY closeness of agreement between the OUTPUT TEMPERATURE of a thermometer and the true value of the measurand NOTE LABORATORY ACCURACY is sometimes referred to as maximum permissible error. 201.3.211 LIMITS OF AGREEMENT LA the magnitude of a potential disagreement between outputs of two CLINICAL THERMOMETERS equal to double the standard deviation of OUTPUT TEMPERATURE differences when used on the same human subjects NOTE
LIMITS OF AGREEMENT can also be described as clinical uncertainty. 201.3.212 MEASURING SITE part of a PATIENT where the temperature is measured EXAMPLES Pulmonary artery, distal oesophagus, sublingual space in the mouth, rectum, ear canal, axilla (armpit), forehead skin. 201.3.213 OPERATING MODE state of a CLINICAL THERMOMETER that gives an OUTPUT TEMPERATURE of an intended REFERENCE BODY SITE 201.3.214 OUTPUT RANGE span between the lowest and highest temperature limits where a CLINICAL THERMOMETER indicates OUTPUT TEMPERATURE within the specified characteristics of LABORATORY ACCURACY 201.3.215 OUTPUT TEMPERATURE temperature indicated by a thermometer NOTE Methods of indication can include printed, spoken, displayed and remotely displayed. 201.3.216 PROBE part of a CLINICAL THERMOMETER that provides a thermal coupling between the SENSOR and the PATIENT NOTE Thermal coupling can be contact or non-contact. 201.3.217 PROBE CABLE EXTENDER cable that connects a CLINICAL THERMOMETER to a PROBE NOTE 1 Not every CLINICAL THERMOMETER utilizes a PROBE CABLE EXTENDER. NOTE 2 A PROBE CABLE EXTENDER can be an APPLIED PART. 201.3.218 PROBE COVER disposable or reusable ACCESSORY of a CLINICAL THERMOMETER that provides a sanitary barrier between the PROBE and the PATIENT 201.3.219 * REFERENCE BODY SITE part of a PATIENT to which the OUTPUT TEMPERATURE refers SIST EN ISO 80601-2-56:2013

ISO 80601-2-56:2009(E) 6 © ISO 2009 – All rights reserved EXAMPLES Pulmonary artery, distal oesophagus, sublingual space in the mouth, rectum, ear canal, axilla (armpit), forehead skin 201.3.220 REFERENCE CLINICAL THERMOMETER RCT CLINICAL THERMOMETER having established CLINICAL ACCURACY and LABORATORY ACCURACY, which is used for CLINICAL ACCURACY VALIDATION of another CLINICAL THERMOMETER 201.3.221 REFERENCE TEMPERATURE SOURCE source of a thermal energy whose temperature is measured by a REFERENCE THERMOMETER EXAMPLES BLACKBODY, FLUID BATH. 201.3.222 REFERENCE THERMOMETER equilibrium thermometer of a contact type for laboratory application whose calibration is traceable to a national standard of temperature, with a specified accuracy and associated uncertainty NOTE An equilibrium thermometer can also be described as a zero-heat flow thermometer. EXAMPLE Platinum resistance thermometer with calibration traceable to a national standard of temperature. 201.3.223 REPROCESSING any activity, not specified in the ACCOMPANYING DOCUMENT, that renders a used product ready for re-use NOTE 1 The term “REPROCESSED” is used to designate the corresponding status. NOTE 2 Such activities are often referred to as refinishing, restoring, recycling, refurbishing, repairing or remanufacturing. NOTE 3 Such activities can occur in healthcare facilities. 201.3.224 SENSOR part of the CLINICAL THERMOMETER that converts thermal energy into an electrical signal 201.3.225 TEST MODE state of a CLINICAL THERMOMETER where the OUTPUT TEMPERATURE represents the temperature measured by the SENSOR and is not adjusted for a REFERENCE BODY SITE or the rate of response of the SENSOR NOTE 1 The TEST MODE can be used for the determination of the LABORATORY ACCURACY of the CLINICAL THERMOMETER. NOTE 2 The TEST MODE can be the DIRECT MODE of the CLINICAL THERMOMETER. 201.4 General requirements IEC 60601-1:2005, Clause 4 applies, except as follows: 201.4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS Additional subclause: SIST EN ISO 80601-2-56:2013

ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved 7 201.4.2.101 Additional requirements for RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS When performing the RISK MANAGEMENT PROCESS required by IEC 60601-1:2005, 4.2, the analysis shall consider the RISKS of changing environmental conditions for the CLINICAL THERMOMETER and provide guidance regarding the RESIDUAL RISKS in the instruction for use. NOTE PORTABLE CLINICAL THERMOMETERS can undergo changing environmental conditions that can affect the LABORATORY ACCURACY. Compliance is checked by inspection of the instructions for use and the RISK MANAGEMENT FILE. 201.4.3 ESSENTIAL PERFORMANCE Additional subclause: 201.4.3.101 * Additional requirements for ESSENTIAL PERFORMANCE Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101. Table 201.101 — Distributed ESSENTIAL PERFORMANCE requirements Requirement Subclause Accuracy of the CLINICAL THERMOMETER or at least one of the following:
⎯ generation of a TECHNICAL ALARM CONDITION; ⎯ not providing an OUTPUT TEMPERATURE; ⎯ marking the ambient temperature operating range. 201.101.2 201.12.1.101 201.4.101
Additional subclause: 201.4.101 Environmental conditions of use A CLINICAL THERMOMETER intended for home healthcare use shall operate in NORMAL USE over the ranges of ⎯ an ambient temperature operating range from 15 °C to 35 °C; and ⎯ a relative humidity range of 15 % to 85 % (non-condensing); or the CLINICAL THERMOMETER shall be marked with the limited environmental operation range and the instructions for use shall disclose the warning of the consequences of operation outside of that range. 201.5 General requirements for testing of ME EQUIPMENT IEC 60601-1:2005, Clause 5 applies. 201.6 Classification of ME EQUIPMENT and ME SYSTEMS IEC 60601-1:2005, Clause 6 applies. 201.7 ME EQUIPMENT identification, marking and documents IEC 60601-1:2005, Clause 7 applies, except as follows: SIST EN ISO 80601-2-56:2013

ISO
...