Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (IEC 60601-2-83:2019)

EN-IEC 60601-2-83 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.

Medizinische elektrische Geräte - Teil 2-83: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Heim-Lichttherapiegeräten (IEC 60601-2-83:2019)

Medizinische elektrische Geräte - Teil 2-83: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Heim-Lichttherapiegeräten (IEC 60601-2-83:2019)

IEC 60601-2-83:2019 s'applique à la SÉCURITÉ DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE LUMINOTHÉRAPIE À DOMICILE conçus pour être utilisés dans l'ENVIRONNEMENT DES SOINS A DOMICILE. Les APPAREILS DE LUMINOTHÉRAPIE À DOMICILE sont généralement utilisés par un OPERATEUR NON SPECIALISTE. Le domaine d'application du présent document comprend toutes les sources de lumière à l'exception des lasers.

Medicinska električna oprema - 2-83. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za svetlobno terapijo na domu (IEC 60601-2-83:2019)

General Information

Status
Published
Publication Date
28-Apr-2020
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
22-Apr-2020
Due Date
27-Jun-2020
Completion Date
29-Apr-2020

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SLOVENSKI STANDARD
SIST EN IEC 60601-2-83:2020
01-junij-2020
Medicinska električna oprema - 2-83. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za svetlobno terapijo na domu (IEC 60601-2-83:2019)

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and

essential performance of home light therapy equipment (IEC 60601-2-83:2019)

Medizinische elektrische Geräte - Teil 2-83: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Heim-Lichttherapiegeräten (IEC

60601-2-83:2019)

Medizinische elektrische Geräte - Teil 2-83: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Heim-Lichttherapiegeräten (IEC

60601-2-83:2019)
Ta slovenski standard je istoveten z: EN IEC 60601-2-83:2020
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN IEC 60601-2-83:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN IEC 60601-2-83:2020
---------------------- Page: 2 ----------------------
SIST EN IEC 60601-2-83:2020
EUROPEAN STANDARD EN IEC 60601-2-83
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
ICS 11.040.60
English Version
Medical electrical equipment - Part 2-83: Particular requirements
for the basic safety and essential performance of home light
therapy equipment
(IEC 60601-2-83:2019)

Appareils électromédicaux - Partie 2-83: Exigences Medizinische elektrische Geräte - Teil 2-83: Besondere

particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der

essentielles des appareils de luminothérapie à domicile wesentlichen Leistungsmerkmale von Heim-

(IEC 60601-2-83:2019) Lichttherapiegeräten
(IEC 60601-2-83:2019)

This European Standard was approved by CENELEC on 2020-01-01. CENELEC members are bound to comply with the CEN/CENELEC

Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 60601-2-83:2020 E
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SIST EN IEC 60601-2-83:2020
EN IEC 60601-2-83:2020 (E)
European foreword

The text of document 62D/1682/FDIS, future edition 1 of IEC 60601-2-83, prepared by SC 62D

"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to

the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-83:2020.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2020-10-03

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2023-04-03

document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a mandate given to CENELEC by the European

Commission and the European Free Trade Association.
Endorsement notice

The text of the International Standard IEC 60601-2-83:2019 was approved by CENELEC as a

European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards

indicated:
IEC 60335-2-113 NOTE Harmonized as FprEN 60335-2-113 to be published
IEC 60601-2-57:2011 NOTE Harmonized as EN 60601-2-57:2011 (not modified)
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 60601-1-12 NOTE Harmonized as EN 60601-1-12
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SIST EN IEC 60601-2-83:2020
EN IEC 60601-2-83:2020 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments)

applies.

NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:

www.cenelec.eu.
The Annex ZA of EN 60601-1:2006 is applicable, except as follows:
Publication Year Title EN/HD Year
Replace
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
ISO 15223-1 2016 Medical devices – Symbols to be used with EN ISO 15223-1 2016
medical device labels, labelling and
information to be supplied – Part 1:
General requirements
+prA1
Addition
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
IEC 60601-1-11 2015 Medical electrical equipment_- Part_1-11: - -
General requirements for basic safety and
essential performance_- Collateral
standard: Requirements for medical
electrical equipment and medical electrical
systems used in the home healthcare
environment
IEC 62471 (mod) 2006 Photobiological safety of lamps and lamp EN 62471 2008
systems
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SIST EN IEC 60601-2-83:2020
EN IEC 60601-2-83:2020 (E)
Publication Year Title EN/HD Year
ISO 3864-1 2011 Graphical symbols - Safety colours and - -
safety signs - Part 1: Design principles for
safety signs and safety markings
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SIST EN IEC 60601-2-83:2020
IEC 60601-2-83
Edition 1.0 2019-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-83: Particular requirements for the basic safety and essential
performance of home light therapy equipment
Appareils électromédicaux –
Partie 2-83: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils de luminothérapie à domicile
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-6953-4

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 60601-2-83:2020
– 2 – IEC 60601-2-83:2019 © IEC 2019
CONTENTS

FOREWORD ........................................................................................................................... 3

INTRODUCTION ..................................................................................................................... 5

201.1 Scope, object and related standards ....................................................................... 6

201.2 Normative references .............................................................................................. 7

201.3 Terms and definitions .............................................................................................. 8

201.4 General requirements ........................................................................................... 10

201.5 General requirements for testing ME EQUIPMENT .................................................... 10

201.6 Classification of ME EQUIPMENT and ME SYSTEMS .................................................... 10

201.7 ME EQUIPMENT identification, marking and documents ........................................... 12

201.8 Protection against electrical HAZARDS from ME EQUIPMENT...................................... 15

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS ............ 15

201.10 Protection against unwanted and excessive radiation HAZARDS ............................. 15

201.11 Protection against excessive temperatures and other HAZARDS ............................. 17

201.12 Accuracy of controls and instruments and protection against hazardous

outputs .......................................................................................................................... 18

201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ............................... 18

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ............................................. 18

201.15 Construction of ME EQUIPMENT ............................................................................... 18

201.16 ME SYSTEMS .......................................................................................................... 18

201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ........................... 18

202 Electromagnetic disturbances – Requirements and tests ............................................... 18

206 Usability ........................................................................................................................ 19

211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS

used in the HOME HEALTHCARE ENVIRONMENT ................................................................... 19

Annexes ............................................................................................................................... 20

Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT

and ME SYSTEMS .................................................................................................................... 21

Annex D (informative) Symbols on marking .......................................................................... 24

Annex AA (informative) Particular guidance and rationale .................................................... 25

Annex BB (informative) Protective eyewear for HOME LIGHT THERAPY EQUIPMENT ................... 28

Bibliography .......................................................................................................................... 29

Index of defined terms used in this particular standard .......................................................... 30

Table 201.101 – EMISSION LIMITS for risk groups of HOME LIGHT THERAPY EQUIPMENT .............. 11

Table 201.102 – Time criteria for risk groups of HOME LIGHT THERAPY EQUIPMENT ................... 12

Table 201.103 – Applicable ANGLE OF ACCEPTANCE for the assessment of emitted

OPTICAL RADIATION from HOME LIGHT THERAPY EQUIPMENT ........................................................ 12

Table 201.C.101 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts ......... 21

Table 201.C.102 –Safety signs per HAZARD and per risk group .............................................. 22

Table 201.C.103 – ACCOMPANYING DOCUMENTS, instructions for use ...................................... 22

Table 201.C.104 –Caution statements per HAZARD and per risk group ................................... 23

Table 201.D.1 – General symbols ......................................................................................... 24

Table 201.D.2 – Safety signs ................................................................................................ 24

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SIST EN IEC 60601-2-83:2020
IEC 60601-2-83:2019 © IEC 2019 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-83: Particular requirements for the basic safety and
essential performance of home light therapy equipment
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC

Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International Standard IEC 60601-2-83 has been prepared by IEC subcommittee 62D:

Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical

practice.
The text of this International Standard is based on the following documents:
FDIS Report on voting
62D/1682/FDIS 62D/1687/RVD

Full information on the voting for the approval of this International Standard can be found in

the report on voting indicated in the above table.

This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this document, the following print types are used:
– requirements and definitions: roman type;
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SIST EN IEC 60601-2-83:2020
– 4 – IEC 60601-2-83:2019 © IEC 2019
– test specifications: italic type;

– informative material appearing outside of tables, such as notes, examples and references: in smaller type.

Normative text of tables is also in a smaller type;

– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS

NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term

– "clause" means one of the seventeen numbered divisions within the table of contents,

inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all

subclauses of Clause 7).

References to clauses within this document are preceded by the term "Clause" followed by

the clause number. References to subclauses within this particular standard are by number

only.

In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any

combination of the conditions is true.

The verbal forms used in this document conform to usage described in Clause 7 of the

ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:

– "shall" means that compliance with a requirement or a test is mandatory for compliance

with this document;

– "should" means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this document;

– "may" is used to describe a permissible way to achieve compliance with a requirement or

test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title

indicates that there is guidance or rationale related to that item in Annex AA.

A list of all parts of the IEC 60601 series, published under the general title Medical electrical

equipment, can be found on the IEC website.

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing

organizations may need a transitional period following publication of a new, amended or revised IEC publication in

which to make products in accordance with the new requirements and to equip themselves for conducting new or

revised tests. It is the recommendation of the committee that the content of this publication be adopted for

implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct

understanding of its contents. Users should therefore print this document using a

colour printer.
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SIST EN IEC 60601-2-83:2020
IEC 60601-2-83:2019 © IEC 2019 – 5 –
INTRODUCTION

This part of IEC 60601 has been prepared to provide safety requirements for HOME LIGHT

THERAPY EQUIPMENT, based on IEC 60601-1 and its collateral standards. This equipment is

intended to be used in the HOME HEALTHCARE ENVIRONMENT and is typically used by a LAY

OPERATOR, who is familiar with this environment and the specific characteristics of lamps.

Some requirements of IEC 60601-1-11 are amended to better suit this type of ME EQUIPMENT

and the environment in which it is used.
HOME LIGHT THERAPY EQUIPMENT provides light therapy by means of eye-mediated

photobiological effects (which can be visual or non-visual) and skin-mediated photobiological

effects (non-visual only). Possible applications include pain relief, psoriasis treatment, and

treatment of winter depression (seasonal affective disorder, SAD).

This document is developed because IEC 60601-2-57 [2] only covers light source equipment

providing light therapy by means of non-visual photobiological effects, which excludes an

important group of light source equipment creating visual photobiological effects. Further,

IEC 60601-2-57 focuses on radiation aspects and related markings but hardly provides any

product-specific safety requirements. IEC 60335-2-113 [1] provides such specific

requirements for household appliances with light sources for cosmetic and beauty care, but

does not apply to equipment with medical purposes. IEC 60601-2-83 addresses all safety

requirements for HOME LIGHT THERAPY EQUIPMENT and has taken over relevant requirements

from [1] and [2].

This document is the first edition of IEC 60601-2-83. It is aligned with IEC 60601-1:2005

and IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010 and
IEC 60601-1-6:2010/AMD1:2013, and IEC 60601-1-11:2015.
___________
Numbers in square brackets refer to the Bibliography.
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SIST EN IEC 60601-2-83:2020
– 6 – IEC 60601-2-83:2019 © IEC 2019
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-83: Particular requirements for the basic safety and
essential performance of home light therapy equipment
201.1 Scope, object and related standards
Clause 1 of the general standard 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

___________

The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance.
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SIST EN IEC 60601-2-83:2020
IEC 60601-2-83:2019 © IEC 2019 – 7 –

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 for IEC 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.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Replacement:

IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral Standard: Electromagnetic disturbances –

Requirements and tests
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SIST EN IEC 60601-2-83:2020
– 8 – IEC 60601-2-83:2019 © IEC 2019

IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic

safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013

ISO 15223-1:2016, Medical devices – Symbols to be used with medical device labels,

labelling and information to be supplied – Part 1: General requirements
Addition:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance
IEC 60601-1:2005/AMD1:2012

IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for

basic safety and essential performance – Collateral Standard: Requirements for medical

electrical equipment and medical electrical systems used in the home healthcare environment

IEC 62471:2006, Photobiological safety of lamps and lamp systems

ISO 3864-1:2011, Graphical symbols – Safety colours and safety signs – Part 1: Design

principles for safety signs and safety markings
201.3 Terms and definitions

For the purposes of this document, the terms and definitions given in IEC 60601-1,

IEC 60601-1-2, IEC 60601-1-6 and IEC 60601-1-11 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following

addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found on page 30.
Addition:
201.3.201
* ANGLE OF ACCEPTANCE
plane angle within which a detector responds to OPTICAL RADIATION

Note 1 to entry: The ANGLE OF ACCEPTANCE can be controlled by apertures or optical elements.

Note 2 to entry: The ANGLE OF ACCEPTANCE is sometimes referred to as
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Questions, Comments and Discussion

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