Standards Development

Scope

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

201.1.1 Scope

Replacement:

This document applies to the basic safety and essential performance of me equipment and me systems intended to be used for projection radiography and indirect radioscopy. IEC 60601-2-43 applies to me equipment and me systems intended to be used for interventional applications and refers to applicable requirements in this document.

Me equipment and me systems intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this document. The scope of this document also excludes radiotherapy simulators.

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.

201.1.2 Object

Replacement:

The object of this document is to establish particular basic safety and essential performance requirements for me equipment and me systems for radiography and radioscopy.

201.1.3 Collateral standards

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 as modified in 201.2.

IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021 apply, as modified in Clauses 202 and 203 respectively. If the manufacturer declares that the me equipment or me system is intended to be operated in a home healthcare environment, then IEC 60601‑1‑11:2015 and IEC 60601-1-11:2015/AMD1:2020 apply and if the manufacturer declares that the me equipment or me system is intended to be operated in an emergency medical services environment, then IEC 60601-1-12:2014 and IEC 60601‑1‑12:2015/ AMD1:2020 apply. IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published.

NOTE 1 Operators of X-ray equipment are used to audible signals as specified in this document rather than to the concepts of IEC 60601-1-8. Therefore IEC 60601-1-8 does not apply.

201.1.4 Particular standards

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 and collateral standards as appropriate for the particular me equipment under consideration, and may add other basic safety and essential performance requirements.

A requirement of a particular standard 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 document 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 collateral standard, 203.4 in this document addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the 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 the 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 the 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 the 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 document, the clause or subclause of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the 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 the applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this document.