201.1 Scope, object and related standards
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 part of IEC 60601‑2 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications; hereafter referred to as light source equipment (LS EQUIPMENT).
This document applies to LS EQUIPMENT of RISK GROUP 1C if the incorporated source of OPTICAL RADIATION is of RG-3, and of Risk Group 3.
NOTE 1 For classification rules for Risk Groups, see 201.6.1.102.
This document does not apply to equipment for sun tanning such as sunlamp products, for ophthalmic instruments, for lighting purposes in medical or cosmetic environments, for photography/video, for equipment which produces visual or non-visual effects such as circadian entrainment, or for infant phototherapy and infant radiant warmers. This document does not apply to sterilization equipment.
This document does not apply to home-use appliances. It does not apply to home light therapy equipment, such as equipment which is intended to be used in the HOME HEALTHCARE ENVIRONMENT and is typically used by a LAY OPERATOR.
NOTE 2 Home-use appliances are covered by IEC 60335‑2‑113:2016 [1] 1. Appliances for skin exposure to OPTICAL RADIATION, such as sunlamp products, are covered by IEC 60335‑2‑27 [2]. Home light therapy equipment providing light therapy by means of eye-mediated photobiological effects, which can be visual or non-visual, and skin-mediated photobiological effects, possible applications including pain relief, psoriasis treatment, and treatment of winter depression (SAD), are also covered by IEC 60601‑2‑83:2019 [3].
NOTE 3 Safety requirements in this document are intended to address only HAZARDS to the eye and superficial tissues including skin or mucosa. As OPTICAL RADIATION does not penetrate more than a few millimetres in tissue, HAZARDS to underlying tissues are not considered.
201.1.2 Object
Replacement:
The objects of this document are:
to establish the risk from optical radiation, specify basic safety and essential performance requirements for LS EQUIPMENT;
to specify requirements for the manufacturer to supply information and establish procedures so that proper precautions can be adopted;
to provide warning to individuals of risks associated with accessible optical radiation from ls equipment through signs, labels and instructions;
to reduce the possibility of adverse effects and injuries by minimizing unnecessary accessible OPTICAL RADIATION; to provide means of improved control of the HAZARDS related to optical radiation through engineering controls;
to specify requirements for protection against other HAZARDS resulting from the operation and use of ls equipment.
201.1.3 Collateral standards
Addition:
This document refers to the 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.
All collateral standards apply, except IEC 60601‑1‑11.
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 606011:2005/AMD2:20201 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 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 3.139, 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 final digit(s) of the collateral standard document number, e.g. 202 for IEC 60601‑1‑2, 203 for IEC 60601‑1‑3, etc.
The term "this standard" is used to make reference to IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, any applicable collateral standards and this document taken together.
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.