Draft Details

Designation:C22.2 NO. 60601-2-83
Source:IEC
Review start date:Sep 7, 2022
Review end date:Nov 6, 2022
Categories:Electrical
Contact email:mary.morgan(at)csagroup.org
Draft Scope/Description:

201.1 Scope, object and related standards

Clause 1 of the general standard2 applies, except as follows:

201.1.1 Scope

Replacement:

This part of IEC 60601 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME

LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR.

The scope of this document includes all light sources except laser.

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 particular standard is to establish particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME LIGHT THERAPY EQUIPMENT.

201.1.3 Collateral standards

Addition:

This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601-1-2:2014, IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-11:2015 apply as modified in Clauses 202, 206 and 211, respectively.

IEC 60601-1-3, IEC 60601-1-8, IEC 60601-1-10 and IEC 60601-1-12 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published.

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