EN IEC 60601-2-75:2019

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

• Status: Published
• Publication Date: 10-Oct-2019
• Withdrawal Date: 06-Aug-2022
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 11-Oct-2019
• Completion Date: 11-Oct-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN IEC 60601-2-75:2019 - 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)

Relations

• Amended By: EN IEC 60601-2-75:2019/A1:2024 - Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
• Effective Date: 11-May-2021

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
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