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BS EN 60601-2-57:2011

$167.15

Medical electrical equipment – Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

Published By Publication Date Number of Pages
BSI 2011 40
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IEC 60601-2-57:2011 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment. IEC 60601-2-57:2011 does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. Light source equipment may consist of a single or multiple sources of optical radiation, with or without power supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.

PDF Catalog

PDF Pages PDF Title
8 English
CONTENTS
10 INTRODUCTION
11 201.1 Scope, object and related standards
13 201.2 Normative references
201.3 Terms and definitions
16 201.4 General requirements
201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
18 201.7 Me equipment identification, marking and documents
21 Figure 201.101 – Example of explanatory label for a device with multiplehazard spectral regions
22 201.8 Protection against electrical hazards from me equipment
Figure 201.102 – Warning label – Hazard symbol
23 201.9 Protection against mechanical hazards of me equipment and me systems
201.10 Protection against unwanted and excessive radiation hazards
24 201.11 Protection against excessive temperatures and other hazards
201.12 Accuracy of controls and instruments and protection against hazardous outputs
25 201.13 Hazardous situations and fault conditions
26 201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
Annexes
27 Annex AA (informative)Particular guidance and rationale
29 Annex BB (informative)Exposure limit Values
33 Annex CC (informative)Protective eyewear for ls equipment
34 Annex DD (informative)Summary of manufacturer’s requirements
35 Annex EE (informative)Symbols on marking
36 Bibliography
37 Index of defined terms used in this particular standard
BS EN 60601-2-57:2011
$167.15