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




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

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® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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– 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.

___________

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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

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 © 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

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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
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.

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 © 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 Lasers
Replace, in the third existing paragraph, “IEC 60601-2-22:2007 and IEC 60601-2-
22:2007/AMD1:2012” with “IEC 60601-2-22:2019”.
Replace, in the third existing paragraph, “201.10.4a) (remote interlock connector) and 201.10.4f)
(target indicating device)” with “201.10.4.101a) (remote interlock connector) and 201.10.4.101f)
(target indicating device)”.
Replace, in Note 102, “IEC 60601-2-22:2007” with “IEC 60601-2-22:2019”.
Replace, in the last paragraph of this subclause, “IEC 60601-2-22:2007 and IEC 60601-2-
22:2007/AMD1:2012” with “IEC 60601-2-22:2019”.
201.11 Protection against excessive temperatures and other HAZARDS
Replace, in the second existing paragraph, “IEC 60601-2-22:2007” with “IEC 60601-2-22:2019”.
201.12.1.101 * Wavelength accuracy
Replace, in the seventh paragraph, "±3 nm" with "±5 nm".
Replace, in the seventh paragraph, "±10 nm" with "±20 nm".
201.12.1.103 * EXPOSURE DURATION CONTROL
Replace, in the fourth paragraph, "±20 %" with "±10 %".
201.12.1.104 * PULSE DURATION and PULSE REPETITION RATE ACCURACY
Replace, in the fourth paragraph, "±20 %" with "±10 %".
201.12.4.4.101 Light emergency stop
Replace, in the first paragraph of this subclause, “IEC 60601-2-22:2007, IEC 60601-2-22:2007”
with “IEC 60601-2-22:2019”.
201.13.1 Specific HAZARDOUS SITUATIONS
Replace the existing text after addition with the following:
The following HAZARDOUS SITUATIONS shall be taken into account for PHOTODYNAMIC THERAPY
AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT regardless of its classification:
a) emission of excessive OUTPUT;
WORKING BEAM;
b) faulty release of the
c) failure of the cutoff of the WORKING BEAM;
BEAM DELIVERY SYSTEM for
d) failure of the calibration process of the transmission of the
PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT devices which provides
means to calibrate the actual OUTPUT of the device to the actual transmission of the BEAM
DELIVERY SYSTEM;

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IEC 60601-2-75:2017/AMD1:2023 – 7 –
© IEC 2023
NOTE Such failure can be the degradation of an integrating sphere due to staining; degradation of its
measurement electronics; degradation of its calibration; degradation or staining of an insert into the integrating
sphere which is frequently re-sterilized.
e) impairment of the sterility of the BEAM DELIVERY SYSTEM;
f) failure of integrity of calibrations due to memory failures, software HAZARDS of connected
devices, or by incompetent service, including service by third parties.
201.14.6 RISK MANAGEMENT process
Replace, in the first paragraph, third paragraph and last paragraph of this subclause,
“IEC 62304:2006” with “IEC 62304:2006 and IEC 62304:2006/AMD1:2015”.
AA.1 General guidance
Replace, in the last paragraph of this subclause, “IEC 60601-2-22:2007” with
“IEC 60601-2-22:2019”.
AA.2 Rationale for particular clauses and subclauses
Table AA.1 – Characteristics relevant to parameters
Replace, in the third column and second line of this table, "Emitting wavelength" with "Emitting
wavelength and spectral profile".
Please replace the existing last line of this table as follows:

OUTPUT profile Depends on the targeted Radiation characteristics Requirements for intended
tissue, the non-targeted associated with OUTPUT OUTPUT profile
viable structure in its vicinity profile
and on the mode of
application, i.e. topical or
interstitial.

Subclause 201.12.1.101 – WAVELENGTH ACCURACY
Replace, in the last paragraph of this subclause, “IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012” with “IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020”.
Add, at the end of the existing text, the following new text:
Wavelength accuracy tolerance can be determined by the photoactivation performance of
photosensitizer. Several reports showed wavelength dependency of photoactivation
performance of photosensitizer in vitro or in vivo [15]. The result of this report can be in line
with the status of wavelength accuracy tolerance of approved laser products for photodynamic
therapy [16].
UTPUT control
Subclause 201.12.1.102 – O
Replace, in this subclause, “ISO 11554:2006” with “ISO 11554:2017” (2 occurrences).
Subclause 201.12.1.103 – EXPOSURE DURATION control
Replace, in this subclause, “ISO 11554:2006” with “ISO 11554:2017”.

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 © IEC 2023
Subclause 201.12.1.104 – PULSE DURATION and PULSE REPETITION RATE accuracy
Replace, in this subclause, “ISO 11554:2006” with “ISO 11554:2017” (2 occurrences).
Subclause 201.12.1.106 – OUTPUT profile accuracy
Replace, in this subclause, “ISO 13694:2015” with “ISO 13694:2018”.
Subclause 201.12.1.107 – Targeting
Replace, in the second paragraph of this subclause, “IEC 60601-2-22:2007, 201.15.101” with
“IEC 60601-2-22:2019, 201.10.4.101 f)”.
Replace the first sentence of last paragraph with the following;
Other systems may be used as the targeting means for PHOTODYNAMIC THERAPY AND
PHOTODYNAMIC DIAGNOSIS EQUIPMENT including magnetic resonance imaging (MRI),
computerized tomography (CT), ultrasound systems, neuro-navigation systems, planification
PHOTODYNAMIC THERAPY etc.
systems for
Subclause 201.13.2.101 – OPTICAL RADIATION HAZARDS
Replace, in this subclause, “IEC 60601-2-22:2007” with “IEC 60601-2-22:2019” (3
occurrences).
Replace, in the first sentence, “any OPTICAL RADIATION HAZARD in SINGLE FAULT CONDITIONS of up
to 100 % for LASER PRODUCTS” with “any OPTICAL RADIATION HAZARD in SINGLE FAULT CONDITIONS
LASER PRODUCTS”.
of up to 50 % for
BB.1 General
Replace, in this subclause, “IEC 60601-1:2005” with “IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”.
Replace, in this subclause, “IEC 60601-2-22:2007” with “IEC 60601-2-22:2019”.
Replace, in this subclause, “ISO 14971:2007” with “ISO 14971:2019”.
BB.3 RISK assessment guidance of PHOTODYNAMIC THERAPY AND PHOTODYNAMIC
DIAGNOSIS EQUIPMENT
Replace, in the existing item d) of the third paragraph, “ISO 14971:2007” with
“ISO 14971:2019”.
Add, at the end of the existing text, the following text:
Assessment strategy for PHOTOTOXICITY potential may be referred to in ICH Guideline S10
“Photosafety Evaluation of Pharmaceuticals“, especially in Sections 4 and 5[16].

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IEC 60601-2-75:2017/AMD1:2023 – 9 –
© IEC 2023
Bibliography
Replace the existing reference [8] to “ISO 13694:2015” with “ISO 13694:2018”.
Replace the existing reference [9] to “ISO 14971:2007” with “ISO 14971:2019”.
Replace the existing reference [10] to “ISO 11554:2006” with “ISO 11554:2017”.
Replace the existing reference [13] to “ISO 11145:2016” with “ISO 11145:2018”.
Add, at the bottom of the existing reference [14], the following new amendment:
IEC 62304:2006/AMD1:2015
Add the following new references [15] to [18] as follows:
[15] E. M. Waterfield, M. E. Renke, C. B. Smits, M. D. Gervais, R. D. Bower, M. S. Stonefield,
J. G. Levy, Wavelength-dependent effects of benzoporphyrin derivative monoacid ring A
in vivo and in vitro, Photochemistry and Photobiology, 1994; Oct;60(4):383-7
[16] Y. Kawase, H. Iseki, Parameter-finding studies of photodynamic therapy for approval in
Japan and the USA, Photodiagnosis and Photodynamic Therapy, 2013;10:434-45
[17] International Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH): ICH Harmonized Tripartite Guideline “Photosafety Evaluation of
Pharmaceuticals” S10. Current Step 4 version, 13 November 2013
[18] International Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH): ICH Harmonized Tripartite Guideline “Quality Risk Management”
Q9. Current Step 4 version, 9 November 2005

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 © IEC 2023
Index of defined terms used in this particular standard
Replace the following existing terms:
AIMING BEAM . IEC 60601-2-22:2019, 201.3.202
APERTURE . IEC 60601-2-22:2019, 201.3.204
BEAM DELIVERY SYSTEM . IEC 60601-2-22:2019, 201.3.205
HAZARD. IEC 60601-1:2005 AND IEC 60601-1:2005/AMD2:2020, 3.39
INTENDED USE . IEC 60601-1:2005 AND IEC 60601-1:2005/AMD2:2020, 3.44
LASER ENERGY . IEC 60601-2-22:2019, 201.3.216
LASER OUTPUT . IEC 60601-2-22:2019, 201.3.216
LS EQUIPMENT . 201.3.207
MANUFACTURER . IEC 60601-1:2005 AND IEC 60601-1:2005/AMD2:2020, 3.55
OPERATOR PROTECTIVE FILTER . IEC 60601-2-22:2019, 201.3.221
OUTPUT POWER . 201.3.211
PATIENT . IEC 60601-1:2005 AND IEC 60601-1:2005/AMD2:2020, 3.76
PULSE REPETITION RATE . ISO 11145:2018, 3.14.3
RISK . IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020, 3.102
RISK ANALYSIS . ISO 14971:2019, 3.19
RISK ASSESSMENT . ISO 14971:2019, 3.20
RISK MANAGEMENT . IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020, 3.107
RISK MANAGEMENT FILE . ISO 14971:2019, 3.25
SINGLE FAULT CONDITION . IEC 60601-1:2005 AND IEC 60601-1:2005/AMD2:2020, 3.116
TARGET WAVELENGTH . 201.3.221
WORKING AREA . IEC 60601-2-22:2019, 201.3.226
WORKING BEAM . IEC 60601-2-22:2019, 201.3.227

Add the following new terms:
RADIANT POWER . IEC 60825-1:2014, 3.74
PHOTOTOXICITY . 201.3.223
Delete the following terms:
RADIANT EXPOSURE . 201.3.218
STAND-BY/READY . IEC 60601-2-22:2007, 201.3.118
SHUTTER . IEC 60601-2-22:2007, 201.3.117

____________

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© IEC 2023
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
____________

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

AMENDEMENT 1

AVANT-PROPOS
Le présent amendement a été établi par le sous-comité 62D: Équipements, logiciels et
systèmes médicaux particuliers, du comité d'études 62 de l’IEC: Équipement médical, logiciels
et systèmes médicaux.
Le texte de cet amendement est issu des documents suivants:
Projet Rapport de vote
62D/2006/FDIS 62D/2017/RVD

Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant
abouti à son approbation.
Le comité a décidé que le contenu de ce document ne sera pas modifié avant la date de stabilité
indiquée sur le site web de l'IEC sous "http://webstore.iec.ch" dans les données relatives au
document recherché. À cette date, le document sera
• reconduit,
• supprimé,
• remplacé par une édition révisée, ou
• amendé.

NOTE L'attention des utilisateurs du présent document est attirée sur le fait que les fabricants d'appareils et les
organismes d'essai peuvent avoir besoin d'une période transitoire après la publication d'une nouvelle publication
IEC ou ISO, ou d'une publication amendée ou révisée, pour fabriquer des produits conformes aux nouvelles
exigences et pour adapter leurs équipements aux nouveaux essais ou aux essais révisés. Le comité recommande
que le contenu de cette publication soit obligatoirement entériné au niveau national au plus tôt en 3 ans après la
date de publication.

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IEC 60601-2-75:2017/AMD1:2023 – 13 –
© IEC 2023
INTRODUCTION à l’Amendement 1
Lors de sa réunion d'octobre 2019 à Shanghai, Chine, le SC 62D de l’IEC a examiné le besoin
d'apporter des modifications administratives/techniques à la plupart des normes qu’il a établies
une fois les projets d’amendements de la série IEC 60601-1 arrivés à leur terme. Ces projets
ont tous été achevés et les amendements publiés en 2020.
La liste complète des documents du sous-comité 62D de l'IEC qui seront modifiés ou révisés
peut être consultée dans le document 62D/1792/DC de l'IEC. Les conclusions et les
observations relatives au DC peuvent être consultées dans le document 62D/1808/INF. Le
rapport d'examen de cet amendement est présenté dans le document 62D/1812/RR.

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201.1.1 Domaine d’application
Remplacer la note de bas de page 1 existante par ce qui suit:
La norme générale est constituée de l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012 et de
l’IEC 60601-1:2005/AMD2:2020, Appareils électromédicaux – Partie 1: Exigences générales
pour la sécurité de base et les performances essentielles.
201.1.4 Normes particulières
Remplacer les trois premiers alinéas de ce paragraphe par les suivants:
Dans la série IEC 60601, des normes particulières spécifient les exigences de SECURITE DE
BASE et de PERFORMANCES ESSENTIELLES pour les APPAREILS EM et les SYSTEMES EM particuliers.
Des normes particulières peuvent modifier, remplacer ou supprimer des exigences contenues
dans la norme générale et dans les normes collatérales applicables selon ce qui est approprié
aux APPAREILS EM et SYSTEMES EM particuliers à l’étude.
Une exigence d'une norme particulière prévaut sur l'exigence correspondante de la norme
générale et des normes collatérales applicables.
Par souci de concision, dans la présente norme particulière, le terme "norme générale" désigne
...