SIST EN IEC 60601-2-75:2019/A1:2024

SLOVENSKI STANDARD
01-november-2024
Medicinska električna oprema - 2-75. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za fotodinamično terapijo in fotodinamično diagnostično
opremo - Dopolnilo A1 (IEC 60601-2-75:2017/AMD1:2023)
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/AMD1:2023)
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/AMD1:2023)
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/AMD1:2023)
Ta slovenski standard je istoveten z: EN IEC 60601-2-75:2019/A1:2024
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 60601-2-75:2019/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM September 2024
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/AMD1:2023)
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/AMD1:2023) (IEC 60601-2-75:2017/AMD1:2023)
This amendment A1 modifies the European Standard EN IEC 60601-2-75:2019; it was approved by CENELEC on 2024-07-31. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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,
Türkiye 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
© 2024 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/A1:2024 E

European foreword
The text of document 62D/2006/FDIS, future edition 1 of IEC 60601-2-75/AMD1, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-05-01
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-07-31
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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-75:2017/AMD1:2023 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 standard indicated:
ISO 13694:2018 NOTE Approved as EN ISO 13694:2018 (not modified)
ISO 14971:2019 NOTE Approved as EN ISO 14971:2019 (not modified) +A11:2021
ISO 11554:2017 NOTE Approved as EN ISO 11554:2017 (not modified)
ISO 11145:2018 NOTE Approved as EN ISO 11145:2018 (not modified)
IEC 62304:2006/A1:2015 NOTE Approved as EN 62304:2006/A1:2015 (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.cencenelec.eu.
Replace EN 60601-1, EN 60601-2-22 and their amendments with :
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022
- - + A13 2024
IEC 60601-2-22 2019 Medical electrical equipment - Part 2-22: EN IEC 60601-2-22 2020
Particular requirements for basic safety and
essential performance of surgical, cosmetic,
therapeutic and diagnostic laser equipment

IEC 60601-2-75 ®
Edition 1.0 2023-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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 978-2-8322-6370-9

– 2 – IEC 60601-2-75:2017/AMD1:2023
© IEC 2023
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

AMENDMENT 1
FOREWORD
This amendment has been prepared by subcommittee 62D: Particular medical equipment,
software, and systems, of IEC technical committee 62: Medical equipment, software, and
systems.
The text of this amendment is based on the following documents:
Draft Report on voting
62D/2006/FDIS 62D/2017/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
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 or
ISO 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 mandatory implementation nationally not earlier than 3 years from the date of publication.

___________
IEC 60601-2-75:2017/AMD1:2023 – 3 –
© IEC 2023
INTRODUCTION to Amendment 1
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601-1 series. Those projects were all completed and the
amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised may be found within the
IEC document 62D/1792/DC. The results and comments on the DC may be found within
62D/1808/INF. The review report for this amendment is 62D/1812/RR.

___________
201.1.1 Scope
Replace the existing footnote 1 with the following:
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance.
201.1.4 Particular standards
Replace the first three paragraphs of this subclause with the following:
In the IEC 60601 series, particular standards specify BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for the particular ME EQUIPMENT and ME SYSTEMS. Particular standards may modify,
replace or delete requirements contained in the general standard and applicable collateral
standards as appropriate for the particular ME EQUIPMENT and ME SYSTEMS under consideration.
A requirement of a particular standard takes priority over the general standard and applicable
collateral standards.
For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are referred to in this particular standard as the general
standard. Collateral standards are referred to by their document number.
201.2 Normative references
Replace the existing references to IEC 60601-1 and IEC 60601-2-22 and their amendments
with the following new references:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-2-22:2019, Medical electrical equipment – Part 2-22: Particular requirements for
basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser
equipment
– 4 – IEC 60601-2-75:2017/AMD1:2023
© IEC 2023
201.3 Terms and definitions
Replace the existing first paragraph with the following:
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and the following definitions
apply.
201.3.201
BEAM DELIVERY SYSTEM
Replace, in the source, the reference “IEC 60601-2-22:2007, 201.3.106” with “IEC 60601-2-
22:2019, 201.3.205”.
201.3.205
LASER ENERGY
Replace the existing definition and source with the following:
RADIANT ENERGY of the WORKING BEAM, incident on the WORKING AREA where the RADIANT ENERGY
is the time integral of the radiant flux Φ over a given duration Δt
[SOURCE: IEC 60601-2-22:2019, 201.3.216, modified – Note 1 to entry deleted.]
201.3.207
LS EQUIPMENT
Replace the existing definition and source with the following:
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
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, modified – Deletion of the term “non-visual”.]
201.3.210
OUTPUT
Replace the existing Note 1 to entry with the following:
Note 1 to entry: OUTPUT defined in this document includes both the definitions LASER OUTPUT in IEC 60601-2-
22:2019, 201.3.216 and IEC 60601-2-22:2019, 201.3.218 and LS EQUIPMENT OUTPUT in IEC 60601-2-57:2011,
201.3.209.
201.3.211
OUTPUT POWER
Replace the existing definition and source with the following:
RADIANT POWER of the WORKING BEAM, incident on the WORKING AREA, where the RADIANT POWER
is the power emitted, transferred, or received in the form of radiation
[SOURCE: IEC 60601-2-22:2019, 201.3.218, modified – Replacement of the term "laser power"
with "OUTPUT POWER".]
201.3.215
PHOTOSENSITIZER
Replace the existing definition with the following:
compound which is used in conjunction with ME EQUIPMENT and which causes PHOTOTOXICITY in
their combined clinical application

IEC 60601-2-75:2017/AMD1:2023 – 5 –
© IEC 2023
201.3.217
PULSE REPETITION RATE
Replace, in the source, “ISO 11145:2016, 3.52” with “ISO 11145:2018, 3.14.3”.
201.3.218
RADIANT EXPOSURE
R
...