IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, Clause 1, applies, except as follows:
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.
Replacement:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements and test methods for MEDICAL BEDS as defined in 201.3.219 intended for CHILDREN as defined in 201.3.207 and ADULTS with atypical anatomy, i.e. ADULTS ranging outside the definition for ADULTS in 202.3.201.
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 and Clause 201.2 of this document.
IEC 60601‑1‑3 and IEC 60601‑1‑10 do not apply. All other published collateral standards in the IEC 60601‑1 series apply as published.
NOTE Some IEC 60601‑1‑8 requirements can be excluded if they do not affect PATIENT safety, could lead to user confusion, or are inappropriate to MEDICAL BED usage.
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, including the collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCe requirements.
Requirements of this document takes priority over IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020.
The numbering of clauses and subclauses of this particular standard corresponds to that of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 with the prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020) 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 document addresses the content of Clause 4 of the IEC 60601‑1‑2:2015 collateral standard, 203.4 in this document addresses the content of Clause 4 of the IEC 60601‑1‑3:2008 collateral standard, etc.). The changes to the text of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 are specified by the use of the following words:
"Replacement" means that the clause or subclause of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard is replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard.
"Amendment" means that the clause or subclause of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 are numbered starting from 201.101. However, due to the fact that definitions in IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 are numbered 3.1 through 3.154, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables 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 60601‑1‑3, etc.
Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this document.
EN 80601-2-89 Ed.1.0
IEC 80601-2-89:2025