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
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 60601-2-75:2019
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
SIST EN IEC 60601-2-75:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 60601-2-75:2019
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SIST EN IEC 60601-2-75:2019
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
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SIST EN IEC 60601-2-75:2019
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
...
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