SIST EN IEC 60601-2-75:2019
(Main)Medical Electrical Equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment (IEC 60601-2-75:2017)
Medical Electrical Equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment (IEC 60601-2-75:2017)
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT.
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.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This document applies to PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT
used for compensation or alleviation of disease, injury or disability.
In the case of combined equipment (e.g. equipment additionally provided with a function or an
APPLIED PART for the target area) such equipment shall also comply with any particular
standard specifying safety requirements for the additional function.
This particular standard does not apply to:
• light therapy equipment intended for use in photothermal ablation, coagulation, and
hyperthermia;
• low-level laser therapy equipment not intended for use with a PHOTOSENSITIZER;
• illumination equipment intended for use in observation, monitoring, and diagnosis, not
intended for use with a PHOTOSENSITIZER.
Medizinische elektrische Geräte - Teil 2-75: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von photodynamischen Therapie- und photodynamischen Diagnosegeräten (IEC 60601-2-75:2017)
Appareils électromédicaux - Partie 2-75: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de thérapie photodynamique et de diagnostic photodynamique (IEC 60601-2-75:2017)
L’IEC 60601-2-75 :2017 s’applique à la sécurité de base et aux performances essentielles des appareils de thérapie photodynamique et de diagnostic photodynamique.
Les dangers inhérents à la fonction physiologique prévue de l’appareil EM ou des systèmes EM relevant du domaine d'application du présent document ne sont pas couverts par les exigences spécifiques du présent document, à l'exception de 7.2.13 et 8.4.1 de la norme générale.
Le présent document s’applique aux appareils de thérapie photodynamique et de diagnostic photodynamique utilisés pour traiter ou soulager une maladie, une blessure ou une incapacité.
Dans le cas d’appareils combinés (par exemple, appareils comportant une fonction ou une partie appliquée supplémentaire pour la zone cible), les appareils concernés sont également conformes à toute norme particulière qui spécifie des exigences de sécurité pour la fonction supplémentaire.
La présente norme particulière ne s’applique pas:
- aux appareils de luminothérapie destinés à être utilisés pour les ablations, coagulations et hyperthermies photothermiques;
- aux appareils de thérapie laser bas niveau non destinés à être utilisés avec un photosensibilisant;
- aux appareils d’éclairage destinés à être utilisés à des fins d’observation, de surveillance et de diagnostic, non destinés à être utilisés avec un photosensibilisant.
Ce document est à utiliser avec l’IEC 60601-1 :2005 et son amendement 1.
Medicinska električna oprema - 2-75. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za fotodinamično terapijo in fotodinamično diagnostično opremo (IEC 60601-2-75:2017)
Ta del standarda IEC 60601 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI za FOTODINAMIČNO TERAPIJO IN FOTODINAMIČNO DIAGNOSTIČNO OPREMO. Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega dokumenta ne vključujejo temeljnih TVEGANJ pri predvideni fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje uporabe tega dokumenta, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda. OPOMBA: Glej tudi točko 4.2 splošnega standarda.
Ta dokument se uporablja za FOTODINAMIČNO TERAPIJO IN FOTODINAMIČNO DIAGNOSTIČNO OPREMO, ki se uporabljata za lajšanje bolezni, poškodb ali invalidnosti. V primeru kombinirane opreme (npr. oprema, dodatno opremljena s funkcijo ali UPORABLJENIM DELOM za ciljno območje) mora biti takšna oprema skladna tudi z morebitnimi drugimi standardi, ki določajo varnostne zahteve za dodatno funkcijo. Ta standard se ne uporablja za:
• opremo za svetlobno terapijo, ki je namenjena uporabi za fototermično ablacijo, koagulacijo in hipertermijo;
• opremo za nizkoenergijsko lasersko terapijo, ki ni namenjena uporabi s FOTOSENZIBILIZATORJEM;
• opremo za osvetljevanje, ki je namenjena uporabi pri opazovanju, nadzorovanju in diagnozi ter ni namenjena uporabi s FOTOSENZIBILIZATORJEM.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 60601-2-75:2019
01-december-2019
Medicinska električna oprema - 2-75. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za fotodinamično terapijo in fotodinamično diagnostično
opremo (IEC 60601-2-75:2017)
Medical Electrical Equipment - Part 2-75: Particular requirements for the basic safety and
essential performance of photodynamic therapy and photodynamic diagnosis equipment
(IEC 60601-2-75:2017)
Medizinische elektrische Geräte - Teil 2-75: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von photodynamischen Therapie-
und photodynamischen Diagnosegeräten (IEC 60601-2-75:2017)
Appareils électromédicaux - Partie 2-75: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de thérapie photodynamique et de
diagnostic photodynamique (IEC 60601-2-75:2017)
Ta slovenski standard je istoveten z: EN IEC 60601-2-75:2019
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 60601-2-75:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 60601-2-75:2019
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SIST EN IEC 60601-2-75:2019
EUROPEAN STANDARD EN IEC 60601-2-75
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2019
ICS 11.040.01
English Version
Medical Electrical Equipment - Part 2-75: Particular requirements
for the basic safety and essential performance of photodynamic
therapy and photodynamic diagnosis equipment
(IEC 60601-2-75:2017)
Appareils électromédicaux – Partie 2-75: Exigences Medizinische elektrische Geräte - Teil 2-75: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de thérapie photodynamique et wesentlichen Leistungsmerkmale von photodynamischen
de diagnostic photodynamique Therapie- und photodynamischen Diagnosegeräten
(IEC 60601-2-75:2017) (IEC 60601-2-75:2017)
This European Standard was approved by CENELEC on 2019-08-07. 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
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-75:2019 E
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EN IEC 60601-2-75:2019 (E)
European foreword
The text of document 62D/1477/FDIS, future edition 1.0 of IEC 60601-2-75, 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 60601-2-75:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-05-07
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-08-07
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.
Endorsement notice
The text of the International Standard IEC 60601-2-75:2017 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:
ISO 13695:2004 NOTE Harmonized as EN ISO 13695:2004 (not modified)
ISO 14971:2007 NOTE Harmonized as EN ISO 14971:2012 (not modified)
ISO 11146-1:2005 NOTE Harmonized as EN ISO 11146-1:2005 (not modified)
IEC 62304:2006 NOTE Harmonized as EN 62304:2006 (not modified)
2
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EN IEC 60601-2-75:2019 (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 applies except as follows:
Publication Year Title EN/HD Year
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 60601-2-22 2007 Medical electrical equipment - Part 2-22: EN 60601-2-22 2013
Particular requirements for basic safety
and essential performance of surgical,
cosmetic, therapeutic and diagnostic laser
equipment
IEC 60601-2-57 2011 Medical electrical equipment - Part 2-57: EN 60601-2-57 2011
Particular requirements for the basic safety
and essential performance of non-laser
light source equipment intended for
therapeutic, diagnostic, monitoring and
cosmetic/aesthetic use
IEC 60825-1 2014 Safety of laser products - Part 1: EN 60825-1 2014
Equipment classification and requirements
+EN 60825-
1:2014/AC:2017-06
+prAA
IEC 62471 (mod) 2006 Photobiological safety of lamps and lamp EN 62471 2008
systems
3
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SIST EN IEC 60601-2-75:2019
IEC 60601-2-75
®
Edition 1.0 2017-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-75: Particular requirements for the basic safety and essential performance
of photodynamic therapy and photodynamic diagnosis equipment
Appareils électromédicaux –
Partie 2-75: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de thérapie photodynamique et de diagnostic
photodynamique
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-4420-3
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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CONTENTS
FOREWORD . 3
201.1 Scope, object and related standards . 5
201.2 Normative references . 7
201.3 Terms and definitions. 7
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 14
201.11 Protection against excessive temperatures and other HAZARDS . 15
201.12 Accuracy of controls and instruments and protection against hazardous
OUTPUTS . 15
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 19
201.15 Construction of ME EQUIPMENT . 20
201.16 ME SYSTEMS . 20
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 20
Annexes . 20
Annex AA (informative) General guidance and rationale . 21
Annex BB (informative) Specific HAZARDOUS SITUATIONS and HARMS and RISK
ASSESSMENT guidance . 25
Bibliography . 27
Index of defined terms used in this particular standard. 28
Table AA.1 – Characteristics relevant to parameters . 22
Table BB.1 – Specific HAZARDOUS SITUATIONS and HARMS . 25
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IEC 60601-2-75:2017 © IEC 2017 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-75: Particular requirements for the basic safety
and essential performance of photodynamic therapy
and photodynamic diagnosis 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 60601-2-75 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1477/FDIS 62D/1490/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
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In this standard, the following print types are used:
• requirements and definitions: roman type;
• 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 standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
• “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
• “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
• “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 publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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IEC 60601-2-75:2017 © IEC 2017 – 5 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-75: Particular requirements for the basic safety
and essential performance of photodynamic therapy
and photodynamic diagnosis equipment
201.1 Scope, object and related standards
1
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT.
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.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This document applies to PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT
used for compensation or alleviation of disease, injury or disability.
In the case of combined equipment (e.g. equipment additionally provided with a function or an
APPLIED PART for the target area) such equipment shall also comply with any particular
standard specifying safety requirements for the additional function.
This particular standard does not apply to:
• light therapy equipment intended for use in photothermal ablation, coagulation, and
hyperthermia;
• low-level laser therapy equipment not intended for use with a PHOTOSENSITIZER;
• illumination equipment intended for use in observation, monitoring, and diagnosis, not
intended for use with a PHOTOSENSITIZER.
___________
1
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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201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS
EQUIPMENT [as defined in 201.3.214].
201.1.3 Collateral standards
Addition:
All collateral standards shall be treated as additional clauses to the general standard. Unless
modified in the body of this document, all collateral standards apply to this particular standard.
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 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.
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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 beginning on page 27.
Clause 2 of the general standard applies, except as follows:
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 60601-2-22:2007, Medical electrical equipment – Part 2-22: Particular requirements for
basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser
equipment
IEC 60601-2-22:2007/AMD1:2012
IEC 60601-2-57:2011, Medical electrical equipment – Part 2-57: Particular requirements for
basic safety and essential performance of non-laser light source equipment intended for
therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 60825-1:2014, Safety of laser products – Part 1: Equipment classification and
requirements
IEC 62471:2006, Photobiological safety of lamps and lamp systems
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012 apply, except as follows:
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 beginning on page 28.
Addition:
201.3.201
BEAM DELIVERY SYSTEM
optical system which guides the OPTICAL RADIATION from its origin to the WORKING AREA
[SOURCE: IEC 60601-2-22:2007, 201.3.106, modified – “Laser radiation” has been replaced
by "OPTICAL RADIATION".]
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201.3.202
EXPOSURE DURATION
duration of a pulse, or series, or train of pulses or of continuous emission of OPTICAL
RADIATION incident upon the human body
Note 1 to entry: For a single pulse, this is the duration between the half-peak power point of the leading edge and
the corresponding point on the trailing edge. For a train of pulses (or subsections of a train of pulses), this is the
duration between the first half-peak power point of the leading pulse and the last half-peak power point of the
trailing pulse.
[SOURCE: IEC 60825-1:2014, 3.35, modified – “Laser radiation” has been replaced by
"OPTICAL RADIATION".]
201.3.203
FLUENCE
quotient of the RADIANT ENERGY of all radiation incident on the outer surface of an infinitely
small sphere centered at the given point by the areas of the diametrical cross-section of that
sphere
dQ
e,o
H =
e,o
dA
where
dQ is the RADIANT ENERGY;
e,o
dA is the cross sectional area.
2
Note 1 to entry: SI unit: Joule per square meter (J/m )
2
[SOURCE: Photochem. Photobiol. 2007, 83 [2] ; 425-432, 2007]
201.3.204
IRRADIANCE
quotient of the RADIANT FLUX incident on an element of the surface containing the point, by the
area of that element
dφ
E=
dA
d∅ is the RADIANT FLUX
dA is the area of the element.
Note 1 to entry: Symbol: E
2
Note 2 to entry: SI unit: watt per square meter (W/m ).
[SOURCE: IEC 60825-1:2014, 3.43, modified – Addition of "containing the point", a key and a
new Note to entry.]
201.3.205
LASER ENERGY
RADIANT ENERGY of the WORKING BEAM, incident on the WORKING AREA
[SOURCE: IEC 60601-2-22:2007, 201.3.111]
___________
2
Numbers in square brackets refer to the Bibliography.
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201.3.206
LASER PRODUCT
any product or assembly of components which constitutes, incorporates or is intended to
incorporate a laser or laser system
[SOURCE: IEC 60825-1:2014, 3.48]
201.3.207
LS EQUIPMENT
ME EQUIPMENT which incorporates one or more sources of OPTICAL RADIATION in the wavelength
range 200 nm to 3 000 nm, with the exception of laser radiation, and which is intended to
create non-visual photo-biological effects in humans or animals for therapeutic, diagnostic,
monitoring, cosmetic/aesthetic or veterinary applications
[SOURCE: IEC 60601-2-57:2011, 201.3.208]
201.3.208
OPTICAL RADIATION
electromagnetic radiation with wavelengths between 100 nm and 1 mm
[SOURCE: IEC 60601-2-57:2011, 201.3.211]
201.3.209
OPTICAL RADIATION INDICATOR
visible means which indicates that the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS
EQUIPMENT makes all persons present in the area aware of the need to take precautions
against hazardous OPTICAL RADIATION
201.3.210
OUTPUT
either radiant power or RADIANT ENERGY emitted by PHOTODYNAMIC THERAPY AND PHOTODYNAMIC
DIAGNOSIS EQUIPMENT
Note 1 to entry: OUTPUT defined in this document includes both the definitions LASER OUTPUT in IEC 60601-2-
22:2007, 201.3.113 and LS EQUIPMENT OUTPUT in IEC 60601-2-57:2011, 201.3.209.
201.3.211
OUTPUT POWER
radiant power of the WORKING BEAM, incident on the WORKING AREA
[SOURCE: IEC 60601-2-22:2007, 201.3.114, modified – Replacement of the term "laser
power" by "OUTPUT POWER".]
201.3.212
PHOTODYNAMIC DIAGNOSIS
diagnosis using a compound [PHOTOSENSITIZER] that, when exposed to specific wavelengths of
light, causes a photonic emission which is targeted to enhance the contrast between diseased
and healthy tissue, and which can be used to monitor the PHOTODYNAMIC THERAPY process
Note 1 to entry: PHOTODYNAMIC DIAGNOSIS is defined different from fluorescence contrast imaging (FCI). FCI is
contrast enhancing technology not involving the use of a PHOTOSENSITIZER. Since this document addresses only
equipment used in combination with a PHOTOSENSITIZER, FCI is outside of the scope of this document.
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– 10 – IEC 60601-2-75:2017 © IEC 2017
201.3.213
PHOTODYNAMIC THERAPY
therapy using a PHOTOSENSITIZER that, when exposed to specific wavelengths of light, causes
a photochemical reaction which is targeted to lead to a therapeutic effect
201.3.214
PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUI
...
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