EN ISO 80601-2-56:2017

European foreword
Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME
       EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME
       SYSTEMS
201.7 ME EQUIPMENT identification, marking and
       documents
201.8 Protection against electrical HAZARDS from
       ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME
       EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
       HAZARDS
201.11 Protection against excessive temperatures and other
       HAZARDS
201.12 Accuracy of controls and instruments and protection
       against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL
       SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
       and ME SYSTEMS
201.101 Laboratory performance requirements
201.102 CLINICAL ACCURACY VALIDATION
201.103 PROBES, PROBE CABLE EXTENDERS
        and PROBE COVERS
202 Electromagnetic disturbances - Requirements and tests
206 Usability
208 General requirements, tests and guidance for alarm
    systems in medical electrical equipment and medical
    electrical systems
211 Requirements for medical electrical equipment and
    medical electrical systems used in the home healthcare
    environment
212 Requirements for medical electrical equipment and
    medical electrical systems intended for use in the
    emergency medical services environment
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and
        ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Reference temperature source
Annex CC (informative) - Reference to the essential
         principles of safety and performance
         of medical devices in accordance with
         ISO 16142-1
Annex DD (informative) - Terminology - Alphabetized
         index of defined terms
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the essential requirements
         of Directive 93/42/EEC [OJ L 169] aimed to be
         covered

ISO 80601-2-56:2017 applies to the 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 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 document does not apply to auxiliary equipment.Me equipment that measures a body temperature is inside the scope of this document.ISO 80601-2-56:2017 does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of groups of individual humans under indoor environmental conditions, which are given in IEC 80601‑2‑59[4].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 document are not covered by specific requirements in this document except in IEC 60601‑1:2005+A1:2012, 7.2.13 and 8.4.1.NOTE Additional information can be found in IEC 60601?1:2005+A1:2012, 4.2.