Draft Details

CSA Scope

201.1.1 *Scope

[Add the following paragraph]

This Standard applies to ME EQUIPMENT and ME SYSTEMS that are intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.

IEC Scope

IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Clause 1, applies, except as follows: 

201.1.1 * Scope 

Replacement: 
 

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201). 
 

This document applies to both electrical and non-electrical (manual) MEDICAL BEDS with or without adjustable functions. This document applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a body length of 155 cm. 

NOTE 1 The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with the CHILD or that the bed will be used by an ADULT. 
If a MANUFACTURER wishes to make a MEDICAL BED that can be used by both a CHILD and an ADULT, e.g. INTERNAL LENGTH of 180 cm or more, then IEC 80601-2-52 and this document apply. 

This document does not apply to: 
•    ADULT only MEDICAL BEDS covered by IEC 80601-2-52; 
•    SPECIALITY MATTRESS covered by the ISO 20342 series[5]; 
•    incubators covered by IEC 60601-2-19; 
•    devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table). 

If a clause or subclause is specifically intended to be applicable to a MEDICAL BED 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 MEDICAL BEDS and to ME SYSTEMS, as relevant. 

HAZARDS inherent in the intended physiological function of MEDICAL BEDS or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1. 

NOTE 2 See also IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 4.2. 

NOTE 3 Whenever the term MEDICAL ELECTRICAL EQUIPMENT (MEE, ME Equipment) is used within the series of IEC 60601 standards, it refers to MEDICAL BEDS, both electrical and non-electrical.