Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

Designation Number:
C22.2 NO. 80601-2-56
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
ICS code(s):
11.040.55
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

201.1 * Scope, object and related standards

IEC 60601‐1:2005+A1:2012, Clause 1 applies, except as follows:

201.1.1 Scope

Replacement:

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[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.

Project need:

To maintain alignment with international requirements on the particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement. This proposed New Edition is being developed at the request of medical equipment suppliers, certification bodies, and the Canadian Health Industries. It will provide the industry with the latest international and national requirements on the basic safety and essential performance of clinical thermometers for body temperature measurement.

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.