IEC 60601-2-57 : 1.0

MEDICAL ELECTRICAL EQUIPMENT - PART 2-57: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF NON-LASER LIGHT SOURCE EQUIPMENT INTENDED FOR THERAPEUTIC, DIAGNOSTIC, MONITORING AND COSMETIC/AESTHETIC USE

International Electrotechnical Committee

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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

Abstract

Applicable to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3000 nm, with the exception of laser radiation, and intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT).