CEI EN 60601-2-57 : 2012
Current
The latest, up-to-date edition.
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
Hardcopy , PDF
English, English - Italian
01-01-2012
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 MANUFACTURERS REQUIREMENTS
ANNEX EE (INFORMATIVE) - SYMBOLS ON MARKINGBIBLIOGRAPHY
BIBLIOGRAPHY
ANNEX ZA (NORMATIVE) - NORMATIVE REFERENCES
TO INTERNATIONAL PUBLICATIONS
WITH THEIR CORRESPONDING
EUROPEAN PUBLICATIONS
ANNEX ZZ (INFORMATIVE) - COVERAGE OF ESSENTIAL
REQUIREMENTS OF EC DIRECTIVES
Describes the 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 photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT).
Committee |
CT 76
|
DevelopmentNote |
Classificazione CEI 76-12. To be read in conjunction with CEI EN 60601-2-1. (05/2012)
|
DocumentType |
Standard
|
Pages |
44
|
PublisherName |
Comitato Elettrotecnico Italiano
|
Status |
Current
|
Standards | Relationship |
IEC 60601-2-57:2011 | Identical |
EN 60601-2-57:2011 | Identical |
BS 8497-2:2008 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Guidance on use |
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