• Shopping Cart
    There are no items in your cart

CEI EN 60601-2-57 : 2012

Current

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

Available format(s)

Hardcopy , PDF

Language(s)

English, English - Italian

Published date

01-10-2012

€92.61
Excluding VAT

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

This Standard applies to the fundamental safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range from 200 nm to 3 000 nm, with the exception of laser radiation, and intended to produce photobiological effects not visible on humans or animals, for therapeutic, diagnostic, surveillance, cosmetic/aesthetic or veterinary equipment from here on called equipment with non-coherent optical source.

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 8497-1:2008 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Specification for products
ISO 3864-2:2016 Graphical symbols — Safety colours and safety signs — Part 2: Design principles for product safety labels
CEI 17-11 : 2ED 1987 INTERRUTTORI DI MANOVRA, SEZIONATORI, INTERRUTTORI - SEZIONATORI IN ARIA E UNITA COMBINATE CON FUSIBILI PER CORRENTE ALTERNATA E TENSIONE NOMINALE NON SUPERIORE A 1.000 V E PER CORRENTE CONTINUA E TENSIONE NOMINALE NON SUPERIORE A 1.200 V
EN 60947-3:2009/A2:2015 LOW-VOLTAGE SWITCHGEAR AND CONTROLGEAR - PART 3: SWITCHES, DISCONNECTORS, SWITCH-DISCONNECTORS AND FUSE-COMBINATION UNITS (IEC 60947-3:2008/A2:2015)
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
IEC 62471:2006 Photobiological safety of lamps and lamp systems
BS 8497-2:2008 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Guidance on use
IEC 60947-3:2008+AMD1:2012+AMD2:2015 CSV Low-voltage switchgear and controlgear - Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units
EN 62471:2008 Photobiological safety of lamps and lamp systems

Access your standards online with a subscription

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

€92.61
Excluding VAT