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
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 applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment. 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. 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 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. This document is to be used with IEC 60601-1:2005 and its amendment 1.
Medizinische elektrische Geräte - Teil 2-75: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von photodynamischen Therapie- und photodynamischen Diagnosegeräten
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
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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)
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
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
– 2 – IEC 60601-2-75:2017 © IEC 2017
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
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.
– 4 – IEC 60601-2-75:2017 © IEC 2017
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.
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
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.
___________
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.
– 6 – IEC 60601-2-75:2017 © IEC 2017
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.
IEC 60601-2-75:2017 © IEC 2017 – 7 –
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".]
– 8 – IEC 60601-2-75:2017 © IEC 2017
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.
Note 1 to entry: SI unit: Joule per square meter (J/m )
[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
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]
___________
Numbers in square brackets refer to the Bibliography.
IEC 60601-2-75:2017 © IEC 2017 – 9 –
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.
– 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 EQUIPMENT
ME EQUIPMENT intended to perform PHOTODYNAMIC THERAPY or provide PHOTODYNAMIC
DIAGNOSIS using light-sensitive compounds in combination with devices producing specific
wavelengths of light
201.3.215
PHOTOSENSITIZER
a compound that, when exposed to specific wavelengths of light, causes a photochemical
reaction and photonic emission
201.3.216
PULSE DURATION
time increment measured between the half-peak power points at the leading and trailing
edges of a pulse
[SOURCE: IEC 60825-1:2014, 3.69]
201.3.217
PULSE REPETITION RATE
number of pulses per second of a repetitively pulsed OPTICAL RADIATION
[SOURCE: ISO 11145:2016, 3.52, modified – Remplacement of "laser pulses" by "pulses",
and "laser" by "OPTICAL RADIATION".]
201.3.218
RADIANT EXPOSURE
quotient of dQ , RADIANT ENERGY incident on an element of the surface containing the point
e
over the given duration, by the area dA of that element
dQ
e
H =
e
dA
where
dQ is the the RADIANT ENERGY;
e
dA is the cross sectional area.
Note 1 to entry: SI unit: Joule per square meter (J/m ).
201.3.219
REACTIVE OXYGEN
oxygen molecules, ions or radicals that have an unpaired electron, thus rendering them
extremely reactive
201.3.220
STAND-BY/READY
modes of operation when mains supply is connected and the mains switch activated, where
the STAND-BY mode means that the OPTICAL RADIATION cannot be available even if the control
switch is activated, and where the READY mode keeps the PHOTODYNAMIC THERAPY AND
IEC 60601-2-75:2017 © IEC 2017 – 11 –
PHOTODYNAMIC DIAGNOSIS EQUIPMENT enabled, so that it is capable of emitting OUTPUT when
the control switch is activated
[SOURCE: IEC 60601-2-22:2007, 201.3.118, modified – "OPTICAL RADIATION" substituted for
“laser” and "OUTPUT" substituted for “LASER OUTPUT”.]
201.3.221
* TARGET WAVELENGTH
wavelength at which the PHOTOSENSITIZER causes a photochemical reaction or fluorescence
Note 1 to entry: The MANUFACTURER of the PHOTOSENSITIZER usually defines the TARGET WAVELENGTH and its
allowed spectral width. For established PHOTOSENSITIZERS the TARGET WAVELENGTH and its allowed spectral width
are usually also published in the literature.
Note 2 to entry: See also 201.12.1.101
201.3.222
WORKING AREA
area which is intended to be irradiated with OUTPUT
[SOURCE: IEC 60601-2-22:2007, 201.3.120, modified – "OUTPUT" substituted for “WORKING
BEAM”.]
201.4 General requirements
Clause 4 of the general standard applies.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
Addition:
MANUFACTURERS of LASER PRODUCTS shall comply with the classification and labelling
requirements of IEC 60825-1:2014. When PHOTODYNAMIC THERAPY AND PHOTODYNAMIC
DIAGNOSIS EQUIPMENT uses a laser source, it is also a LASER PRODUCT in the understanding of
IEC 60825-1:2014.
MANUFACTURERS of intense light products shall associate these devices with a RISK group
according to IEC 62471:2006. LS EQUIPMENT for therapeutic or diagnostic purposes shall be
associated with a RISK group according to IEC 60601-2-57:2011.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2.2 Identification
Additional subclause:
– 12 – IEC 60601-2-75:2017 © IEC 2017
201.7.2.101 Additional items
If the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT is LASER PRODUCT,
IEC 60601-2-22:2007, 201.7.2.101 applies.
If the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT is LS EQUIPMENT,
IEC 60601-2-57:2011, 201.7.101 applies.
201.7.9.2 Instructions for use
201.7.9.2.1 * General
Addition:
The instructions for use shall give adequate instructions for proper operation, including clear
warnings concerning the precautions necessary to avoid possible exposure to hazardous
OPTICAL RADIATION.
The instructions for use shall identify the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC
DIAGNOSIS EQUIPMENT by including, as applicable, the following:
• the PHOTOSENSITIZER(S) and their excitation wavelengths intended for use with the
PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT,
• the BEAM DELIVERY SYSTEMS intended for use with the PHOTODYNAMIC THERAPY AND
PHOTODYNAMIC DIAGNOSIS EQUIPMENT.
NOTE 101 “As applicable” means that the requirement should be performed unless specific justification not to is
provided.
NOTE 102 Refer to Annex AA.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall include (as applicable):
PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT is LASER PRODUCT,
• If the
IEC 60601-2-22:2007, 201.7.9.2.101 shall be applied;
• If the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT is LS EQUIPMENT,
IEC 60601-2-57:2011, 201.7.9.2.101 shall be applied;
• the classification of the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT
as specified in IEC 60825-1:2014 or IEC 62471:2006;
• information and guidance for regular calibration of the OUTPUT and wavelength of the
WORKING BEAM. The information shall include a specification for the measuring equipment,
frequency of calibration and any clarification requirements concerning regular calibration
of the OUTPUT and wavelength of the WORKING BEAM;
• a note, stating that PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT
should be protected against unauthorized use;
NOTE 101 For example by removal of a key or other similar security means.
• a specification for eye protection for the user and for the PATIENT including a specification
PATIENT which withstands a continuous
for eye protection for the user and for the
irradiation.;
NOTE 102 Appropriate eye protection for the PATIENT can be different from the eye protection for the USER,
for example when the treated area is on the face or in the vicinity of the PATIENT’s eye.
NOTE 103 Refer to 8.4.5.2 of IEC TR 60825-14:2004.
IEC 60601-2-75:2017 © IEC 2017 – 13 –
• information on HAZARDS and RISKS associated with the combination of PHOTODYNAMIC
THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT and PHOTOSENSITIZERS;
• HAZARDOUS SITUATIONS resulting from the use of combination equipment;
• a warning to confirm the relationship between the irradiation parameters indicated by the
PHOTOSENSITIZER and the parameter settings of the PHOTODYNAMIC THERAPY AND
PHOTODYNAMIC DIAGNOSIS EQUIPMENT;
• if applicable, a specification for skin protection;
• a note, stating that the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT
shall not be used if the INTENDED USE or the indication for use of the PHOTODYNAMIC
THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT do not coincide with the INTENDED USE or
the indication for use of the PHOTOSENSITIZER.
NOTE 104 “As applicable” means that the requirement should be performed unless specific justification not to
is provided.
The user should consult the instructions for use and relevant prescription information of the
PHOTOSENSITIZER regarding its INTENDED USE, indication, contraindications and side effects.
Additional subclause:
201.7.9.2.5.101 ME EQUIPMENT description
The instructions for use shall include:
• performance characteristic values including, but not limited to, wavelength, PULSE
DURATION, PULSE REPETITION RATE, OUTPUT POWER or energy, WORKING AREA, exposure time
and OUTPUT profile;
• maximum OUTPUT POWER or energy.
201.7.9.2.13 Maintenance
Addition:
The instructions for maintenance shall include clear warnings concerning precautions to avoid
possible exposure to hazardous OPTICAL RADIATION.
Additional subclause:
201.7.9.2.101 ACCESSORIES, supplementary equipment and material
The instructions for use shall include:
• a description of the BEAM DELIVERY SYSTEMS connected to PHOTODYNAMIC THERAPY AND
PHOTODYNAMIC DIAGNOSIS EQUIPMENT including the following characteristics when
connected:
– OUTPUT,
– WORKING AREA,
– OUTPUT distribution,
– targeting means for appropriate use,
– calibration instruction;
• a description of specific eye protection for the PATIENT if different from the eye protection
for the user;
• a description of specific endotracheal tubes if relevant for the INTENDED USE.
– 14 – IEC 60601-2-75:2017 © IEC 2017
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows.
Addition:
If the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT is a LASER PRODUCT,
IEC 60601-2-22:2007 and IEC 60601-2-22:2007/AMD1:2012, 201.8 applies.
If the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT is LS EQUIPMENT,
IEC 60601-2-57:2011, 201.8 applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies, except as follows:
201.10.4 Lasers
Addition:
The MANUFACTURER shall address relevant eye and skin damage RISKS to PATIENTS associated
with OPTICAL RADIATION from PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT
PHOTOSENSITIZER accumulation. The MANUFACTURER shall determine appropriate
considering
warnings and rules for the safe behavior of PATIENTS in order to minimize the RISKS to an
acceptable level. Such warnings and rules shall be added to the instructions for use
NOTE 101 Warnings and rules for LEDs are described in IEC 60601-2-57:2011.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
If the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT is a LASER PRODUCT,
all requirements of IEC 60601-2-22:2007 and IEC 60601-2-22:2007/AMD1:2012 with the
exception of 201.10.4a) (remote interlock connector) and 201.10.4f) (target indicating device)
shall be applied.
NOTE 102 This requirement is only applicable if the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS
EQUIPMENT falls into the scope of IEC 60601-2-22:2007.
If the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT is LS EQUIPMENT, all
OUTPUT
requirements of IEC 60601-2-57:2011, 201.10 with the exception of 201.10.103 (
uniformity) shall apply.
NOTE 103 This requirement is only applicable if the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS
EQUIPMENT falls into the scope of IEC 60601-2-57:2011.
NOTE 104 In the context of this document, "light" radiation is understood to cover OPTICAL RADIATION as specified
in IEC 60825-1:2014.
NOTE 105 PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT is used in rooms identified as LASER
CONTROLLED AREAS. In clinical practice, the interlock system is typically not used due to the regular flow of medical
staff into and out of the treatment room.
IEC 60601-2-75:2017 © IEC 2017 – 15 –
Compliance is checked by following the relevant PROCEDURES of IEC 60825-1:2014,
IEC 60601-2-22:2007, IEC 60601-2-22:2007/AMD1:2012 and IEC 60601-2-57:2011.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
Addition:
PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT is a LASER PRODUCT,
If the
IEC 60601-2-22:2007, 201.11 applies.
201.12 Accuracy of controls and instruments and protection against
hazardous OUTPUTS
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Additional subclauses:
201.12.1.101 * Wavelength accuracy
PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT shall incorporate a means
for indicating the pre-set level of the wavelength of the WORKING BEAM. If the wavelength is
fixed by the MANUFACTURER and is not adjustable, the fixed wavelength should be stated in the
labelling.
The accuracy of the data and controls relating to the wavelength shall be specified in the
instructions for use.
The indication shall be in SI units.
The actual value of the wavelength of the WORKING BEAM shall not deviate from the set value
over the accuracy determined by RISK MANAGEMENT by the MANUFACTURER based on INTENDED
USE.
Compliance is checked by functional testing and inspection of the RISK MANAGEMENT FILE.
The MANUFACTURER shall establish the spectral deviation of the wavelength of the WORKING
BEAM from the TARGET WAVELENGTH by means of RISK MANAGEMENT. If the MANUFACTURER does
not establish other specifications for the spectral deviation of the wavelength of the WORKING
BEAM from the TARGET WAVELENGTH in the RISK MANAGEMENT FILE, the following shall apply:
• If the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT is LASER PRODUCT,
WORKING BEAM measured in the WORKING AREA shall contain
the actual wavelength of the
90 % of its OUTPUT POWER within a spectral range of ±3 nm around the TARGET
WAVELENGTH of the PHOTOSENSITIZER. This condition shall be met for 95 % of the EXPOSURE
DURATION.
• If the PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT is LS EQUIPMENT,
the actual wavelength of the WORKING BEAM measured in the WORKING AREA shall contain
90 % of its OUTPUT POWER within a spectral range of ±10 nm around the TARGET
WAVELENGTH of the PHOTOSENSITIZER. This condition shall be met for 95 % of the EXPOSURE
DURATION.
– 16 – IEC 60601-2-75:2017 © IEC 2017
The calibration of the system shall be checked at regular intervals against the wavelength
actually emitted onto the WORKING AREA. The calibration method used shall be described in
th
the instructions for use in accordance with 201.7.9.2.2, 4 bullet of this document.
If the MANUFACTURER of the PHOTOSENSITIZER defines a different specification for the
PHOTOSENSITIZER in the instructions for use of the PHOTOSENSITIZER, the wavelength
MANUFACTURER of the PHOTOSENSITIZER should be followed.
specifications of the
Compliance is checked by inspection and measurements.
201.12.1.102 * OUTPUT control
PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT shall incorporate a means
for the indication of the pre-set level of the OUTPUT of the WORKING BEAM. If the OUTPUT is fixed
by the MANUFACTURER and is not adjustable, labelling on the equipment may state the fixed
OUTPUT.
The accuracy of the data and controls relating to the OUTPUT shall be specified in the
instruction for use.
The indication shall be in SI units.
The actual OUTPUT POWER measured in the WORKING AREA shall not devi
...
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