IEC 60601-2-57:2011

FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 General requirements for testing ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and
   documents
8 Protection against electrical HAZARDS from ME
   EQUIPMENT
9 Protection against MECHANICAL HAZARDS of ME
   EQUIPMENT and ME SYSTEMS
10 Protection against unwanted and excessive
   radiation HAZARDS
11 Protection against excessive temperatures
   and other HAZARDS
12 Accuracy of controls and instruments and
   protection against hazardous outputs
13 HAZARDOUS SITUATIONS and fault conditions
14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
   (PEMS)
15 Construction of ME EQUIPMENT
16 ME SYSTEMS
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

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.