EN 60601-2-57:2011

FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and
       documents
201.8 Protection against electrical HAZARDS from
       ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of
       ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive
       radiation HAZARDS
201.11 Protection against excessive temperatures
       and other HAZARDS
201.12 Accuracy of controls and instruments and
       protection against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
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
Annex AA (informative) - Particular guidance and
         rationale
Annex BB (informative) - Exposure limit values
Annex CC (informative) - Protective eyewear for LS
         EQUIPMENT
Annex DD (informative) - Summary of MANUFACTURER'S
         requirements
Annex EE (informative) - Symbols on marking
Bibliography
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

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.