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BS EN IEC 60601-2-75:2019

BS EN IEC 60601-2-75:2019

Current

Current

The latest, up-to-date edition.

Medical Electrical Equipment Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-14-2019

Publisher

British Standards Institution

This part of IEC 60601 applies to 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.

Committee
CH/62/4
DocumentType
Standard
ISBN
9780580920301
Pages
36
ProductNote
THIS STANDARD ALSO REFERS TO EN 60601-1:2006/corrigendum Mar. 2010, EN 60601-1:2006/A11:2011, EN 60601-1:2006, EN 60601-1:2006/A1:2013, EN 60825-1:2014, EN 62304:2006
PublisherName
British Standards Institution
Status
Current

Standards Relationship
EN 60335-1:2002/A14:2010 Identical
IEC 60601-2-75:2017 Identical
EN IEC 60601-2-75:2019 Identical

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Hardcopy - English
PDF - English
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