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

Amendment 1 - Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

Amendement 1 - 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

General Information

• Status: Published
• Publication Date: 29-Jan-2023
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 33 - TC 62/SC 62D/MT 33
• Current Stage: PPUB - Publication issued
• Start Date: 24-Feb-2023
• Completion Date: 30-Jan-2023

Relations

• Amends: 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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
IEC 60601-2-75:2017-05/AMD1:2023-01(en-fr)

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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 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 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
Replace the existing term, definition and Note 1 to entry with "(Void)".
201.3.220
STAND-BY/READY
Replace the existing term, definition and source with "(Void)".
201.3.222
WORKING AREA
Replace, in the source, “IEC 60601-2-22:2007, 201.3.120” with “IEC 60601-2-22:2019,
201.3.226”.
Add the following new term and definition:
201.3.223
PHOTOTOXICITY
clinically relevant damage to living tissues arising from the photochemical action of compound
used for medical diagnosis or therapy when combined with light delivered by the ME EQUIPMENT
Note 1 to entry: Relevant damage can be assessed by the rationale described in ICH Guideline S10 “Photosafety
Evaluation of Pharmaceuticals“, especially in Sections 4 and 5, in a way which is consistent with ICH Guideline Q9
“Quality Risk Management”.
201.7.2.101 Additional items
Replace, in the first paragraph of this subclause, “IEC 60601-2-22:2007” with
“IEC 60601-2-22:2019”.
201.7.9.2.2 Warning and safety notices
Replace, in the first dash of first paragraph, “IEC 60601-2-22:2007” with
“IEC 60601-2-22:2019”.
201.7.9.2.5.101 ME EQUIPMENT description
Add, at the end of this subclause, the following NOTE:
NOTE Refer to Clause AA.2 subclauses 201.12.1.101 to 201.12.1.106 as specification of performance
characteristics.
201.7.9.2.101 ACCESSORIES, supplementary equipment and material
Replace, in the second dash of the first paragraph, “WORKING AREA” with “working distance and
related WORKING AREA”.
OUTPUT distribution” with “OUTPUT profile”.
Replace, in the third dash of the first paragraph, “
Add, at the end of this subclause, the following NOTE:
NOTE Refer to Clause AA.2 subclauses 201.12.1.101 to 201.12.1.106 as specification of performance
characteristics.
– 6 – IEC 60601-2-75:2017/AMD1:2023
© IEC 2023
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Replace, in the second existing paragraph, “IEC 60601-2-22:2007, IEC 60601-2-
22:2007/AMD1:2012” with “IEC 60601-2-22:2019”.
201.10.4
...