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BS EN IEC 60601-2-83:2020+A11:2021

Current

Current

The latest, up-to-date edition.

Medical electrical equipment Particular requirements for the basic safety and essential performance of home light therapy equipment

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-04-2021

Clause1 of the general standard2 applies, except as follows: 201.1.1 Scope Replacement: This part of IEC60601 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 Clause2 of the general standard and Clause201.2 of this particular standard. IEC60601‑1‑2:2014, IEC60601‑1‑6:2010 and IEC60601‑1‑6:2010/AMD1:2013 and IEC60601‑1‑11:2015 apply as modified in Clauses202, 206 and 211, respectively. IEC60601‑1‑3, IEC60601‑1‑8, IEC60601‑1‑10 and IEC60601‑1‑12 do not apply. All other published collateral standards in the IEC60601‑1 series apply as published. 201.1.4 Particular standards Replacement: In the IEC60601 series, particular standards may modify, replace or delete requirements contained in the general standard 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 the general standard. For brevity, IEC60601‑1:2005 and IEC60601‑1:2005/AMD1:2012 are referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix \'201\' (e.g. 201.1 in this document addresses the content of Clause1 of the general standard) 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 particular standard addresses the content of Clause4 of the IEC60601‑1‑2 collateral standard, 203.4 in this particular standard addresses the content of Clause4 of the IEC60601‑1‑3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: \'Replacement\' means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. \'Addition\' means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. \'Amendment\' means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered from 3.1 through 3.147, 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 IEC60601‑1‑2, 203 forIEC60601‑1‑3, etc. The term \'this document\' is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.

Committee
CH/62/4
DocumentType
Standard
Pages
44
PublisherName
British Standards Institution
Status
Current

Standards Relationship
EN IEC 60601-2-83:2020/A11:2021 Identical
IEC 60601-2-83:2019 Identical

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