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

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.

201.1.4 Particular standards

Replacement:

In the IEC 60601 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, IEC 60601‑1:2005 and IEC 60601‑1:2005/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 Clause 1 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 Clause 4 of the IEC 60601‑1‑2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601‑1‑3 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 IEC 60601‑1‑2, 203 forIEC 60601‑1‑3, 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.

PDF Catalog

PDF Pages	PDF Title
2	undefined
6	Annex ZA (normative)Normative references to international publications with their corresponding European publications
14	English CONTENTS
15	FOREWORD
17	INTRODUCTION
18	201.1 Scope, object and related standards
19	201.2 Normative references
20	201.3 Terms and definitions
22	201.4 General requirements 201.5 General requirements for testing me equipment 201.6 Classification of me equipment and me systems
23	Tables Table 201.101 – Emission limits for risk groups of home light therapy equipment
24	201.7 Me equipment identification, marking and documents Table 201.102 – Time criteria for risk groups of home light therapy equipment Table 201.103 – Applicable angle of acceptance for the assessmentof emitted optical radiation from home light therapy equipment
27	201.8 Protection against electrical hazards from me equipment 201.9 Protection against mechanical hazards of me equipment and me systems 201.10 Protection against unwanted and excessive radiation hazards
29	201.11 Protection against excessive temperatures and other hazards
30	201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.13 Hazardous situations and fault conditions for me equipment 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment 201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems 202 Electromagnetic disturbances – Requirements and tests
31	206 Usability 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
32	Annexes
33	Annex C(informative)Guide to marking and labelling requirements for me equipment and me systems Table 201.C.101 – Marking on the outside of me equipment, me systems or their parts
34	Table 201.C.102 –Safety signs per hazard and per risk group Table 201.C.103 – Accompanying documents, instructions for use
35	Table 201.C.104 –Caution statements per hazard and per risk group
36	Annex D(informative)Symbols on marking Table 201.D.1 – General symbols Table 201.D.2 – Safety signs
37	Annex AA(informative)Particular guidance and rationale
40	Annex BB(informative)Protective eyewear for home light therapy equipment
41	Bibliography
42	Index of defined terms used in this particular standard

Status	Revision Underway
Title	Medical electrical equipment – Particular requirements for the basic safety and essential performance of home light therapy equipment
Replaces	BS EN IEC 60601-2-83:2020
Publisher	BSI
Committee	CH/62/4
Pages	44
Publication Date	2021-04-08
ISBN	978 0 539 15936 3
Standard Number	BS EN IEC 60601-2-83:2020+A11:2021
Identical National Standard Of	EN IEC 60601-2-83:2020/A11:2021, EN IEC 60601-2-83:2020/A11:2021, IEC 60601-2-83:2019
Descriptors	Medical equipment, Light therapy, Performance, Safety, Medical electrical equipment
Amends	BS EN IEC 60601-2-83:2020
ICS Codes	11.040.60 - Therapy equipment