201.1 Scope, object and related standards
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 part of IEC 60601 applies to the basic safety and essential performance of non-thermal plasma wound treatment equipment and non-thermal plasma wound treatment accessories.
non-thermal plasma wound treatment equipment and non-thermal plasma wound
treatment accessories are not intended to supply heat to the patient. They are used to treat chronic and acute wounds and biological tissue as well as diverse skin and itching diseases.
hazards inherent in the intended physiological function of plasma wound treatment equipment and non-thermal plasma wound treatment accessories within the scope of this document are covered by specific requirements in 7.2.13 of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020.
This document does not apply to me equipment intended for the haemostasis of biological tissue (see IEC 60601‑2‑2[1]1 and IEC 60601‑2‑76[2]).
201.1.2 Object
Replacement:
The object of this document is to establish particular basic safety and essential performance requirements for non-thermal plasma wound treatment equipment and non-thermal plasma wound treatment accessories, as defined in 201.3.204 and 201.3.203.
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 and Clause 201.2 of this document.
IEC 60601‑1‑3[3] and IEC 60601‑1‑10[4] do not apply. All other published collateral standards in the IEC 60601‑1 series apply as published.
201.1.4 Particular standards
Addition:
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 60601-1-3 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 in 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.
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 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.