Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (Adopted ISO 80601-2-56:2017, second edition, including ISO amendment 1:2018, 2017-03)
This is the second edition of CSA C22.2 No. 80601-2-56, Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-56 (second edition, 2017-03), including ISO Amendment 1:2018. It supersedes the previous edition, published in 2012 as CAN/CSAC22.2 No. 80601-2-56 (adopted ISO 80601-2-56:2009). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.
For brevity, this Standard will be referred to as CSA C22.2 No. 80601-2-56 throughout.
This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations).
This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.
This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.
Scope and object
IEC 60601-1:2005+A1:2012, Clause 1 applies, except as follows:
This document 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.
This document 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.
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.
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 of 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.