IEC 60601-2-57:2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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 , PDF 3 Users , PDF 5 Users , PDF 9 Users
07-27-2023
English, English - French, Spanish, Castilian
01-31-2011
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.
| Committee |
TC 76
|
| DevelopmentNote |
Stability Date: 2018. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
74
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 60601-2-57 : 2012 | Identical |
| NBN EN 60601-2-57 : 2011 | Identical |
| NEN EN IEC 60601-2-57 : 2011 | Identical |
| I.S. EN 60601-2-57:2011 | Identical |
| PN EN 60601-2-57 : 2011 | Identical |
| AS IEC 60601.2.57:2014 | Identical |
| VDE 0750-2-57 : 2011 | Identical |
| DIN EN 60601-2-57 : 2011 | Identical |
| SN EN 60601-2-57 : 2011 | Identical |
| UNE-EN 60601-2-57:2012 | Identical |
| BS EN 60601-2-57:2011 | Identical |
| CEI EN 60601-2-57 : 2012 | Identical |
| EN 60601-2-57:2011 | Identical |
| CSA C22.2 NO. 60601-2-57:11 (R2021) | Identical |
| CSA C22.2 No. 60601-2-57:2011 | Identical |
| CSA C22.2 No. 60601-2-57 : 2011 : R2016 | Identical |
| AAMI IEC TIR 60878 : 2003 | GRAPHICAL SYMBOLS FOR ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE |
| ISO 12609-2:2013 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Part 2: Guidance for use |
| PD IEC/TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| 14/30284310 DC : 0 | BS ISO 10650 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS |
| BS ISO 12609-2:2013 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Guidance for use |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| PD IEC/TR 62471-3:2015 | Photobiological safety of lamps and lamp systems Guidelines for the safe use of intense pulsed light source equipment on humans |
| 12/30266914 DC : 0 | BS ISO 12609-2 - EYEWEAR FOR PROTECTION AGAINST INTENSE LIGHT SOURCES USED ON HUMANS AND ANIMALS FOR COSMETIC AND MEDICAL APPLICATIONS - PART 2: GUIDANCE FOR USE |
| DIN EN ISO 10650 E : 2016 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015) |
| ISO 12609-1:2013 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Part 1: Specification for products |
| CSA C22.2 No. 60601.2.18 : 2011 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-18: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ENDOSCOPIC EQUIPMENT |
| BS EN ISO 10650:2015 | Dentistry. Powered polymerization activators |
| BS EN 60601-2-18:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of endoscopic equipment |
| NF EN 80601-2-60 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| CSA C22.2 No. 80601-2-60 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT |
| I.S. EN 60601-2-18:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-18: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ENDOSCOPIC EQUIPMENT |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| CSA C22.2 No. 60601.2.18 : 20111 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-18: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ENDOSCOPIC EQUIPMENT |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| IEC 60601-2-75:2017 | Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment |
| BS EN 80601-2-60:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of dental equipment |
| EN ISO 10650:2015 | Dentistry - Powered polymerization activators (ISO 10650:2015) |
| CEI EN 80601-2-60 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT |
| DIN EN ISO 10650:2016-02 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015) |
| IEC 80601-2-60:2012 | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| EN 80601-2-60:2015 | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| UNE-EN 60601-2-18:2016 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| EN 16372:2014 | Aesthetic surgery services |
| I.S. EN ISO 10650:2015 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015) |
| BS EN 16372:2014 | Aesthetic surgery services |
| BS ISO 12609-1:2013 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Specification for products |
| 12/30266915 DC : 0 | BS ISO 12609-1 - EYEWEAR FOR PROTECTION AGAINST INTENSE LIGHT SOURCES USED ON HUMANS AND ANIMALS FOR COSMETIC AND MEDICAL APPLICATIONS - PART 1: SPECIFICATION FOR PRODUCTS |
| I.S. EN 80601-2-60:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT |
| ISO 10650:2015 | Dentistry Powered polymerization activators |
| UNE-EN ISO 10650:2016 | Dentistry - Powered polymerization activators (ISO 10650:2015) |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| EN 60601-2-18:2015 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| 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 |
| 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 |
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