EN 60601-2-41:2009/A1:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-41: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS (IEC 60601-2-41:2009/A1:2013)
14-01-2022
12-01-2013
FOREWORD
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 of 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
Annex AA (informative) - Guidance and rationale for
particular clauses and subclauses
Bibliography
Index of defined terms
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Coverage of Essential Requirements
of EC Directives
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT.
| Committee |
TC 62
|
| DevelopmentNote |
To be read in conjunction with EN 60601-1:1990 (05/2001)
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| IEC 60601-2-41:2009+AMD1:2013 CSV | Identical |
| NBN EN 60601 2-41 : 2010 AMD 2 2015 | Identical |
| NEN EN IEC 60601-2-41 : 2010 AMD 1 2015 | Identical |
| I.S. EN 60601-2-41:2009 | Identical |
| PN EN 60601-2-41 : 2010 AMD 1 2015 | Identical |
| SN EN 60601-2-41 : 2009 AMD 11 2011 | Identical |
| DIN EN 60601-2-41 : 2016 | Identical |
| VDE 0750-2-41 : 2016 | Identical |
| BS EN IEC 62368-1:2020+A11:2020 | Identical |
| CEI EN 60601-2-41/A1 : 2016 | Identical |
| SN EN 60601-2-41:2009+A1:2015 | Identical |
| I.S. EN 60601-2-41:2009/A1:2015 | Identical |
| BS EN 60601-2-41 : 2009 | Identical |
| UNE-EN 60601-2-41:2010 | Identical |
| NF EN 60601-2-41 : 2010 AMD 1 2015 | Identical |
| OVE/ONORM EN 60601-2-41 : 2016 | Identical |
| BS EN 60601-2-41:2009+A1:2015 | Identical |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| I.S. EN 60598-2-25:1996 | LUMINAIRES - PART 2: PARTICULAR REQUIREMENTS - SECTION 25: LUMINAIRES FOR USE IN CLINICAL AREAS OF HOSPITALS AND HEALTH CARE BUILDINGS |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| EN 16372:2014 | Aesthetic surgery services |
| BS EN 16372:2014 | Aesthetic surgery services |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| ISO 9680:2014 | Dentistry Operating lights |
| IEC 60601-2-50:2009+AMD1:2016 CSV | Medical electrical equipment - Part 2-50: Particular requirementsfor the basic safety and essential performance of infant phototherapy equipment |
| EN 60598-2-1:1989 | Luminaires - Part 2: Particular requirements - Section 1: Fixed general purpose luminaires |
| IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| ISO 11664-1:2007 | Colorimetry Part 1: CIE standard colorimetric observers |
| EN 60598-2-9:1989/A1:1994 | Luminaires - Part 2: Particular requirements - Section 9: Photo and film luminaires (non-professional) |
| IEC 60598-2-25:1994 | Luminaires - Part 2: Particular requirements - Section 25: Luminaires for use in clinical areas of hospitals and health care buildings |
| IEC 60598-1:2014+AMD1:2017 CSV | Luminaires - Part 1: General requirements and tests |
| IEC 60598-2-22:2014+AMD1:2017 CSV | Luminaires - Part 2-22: Particular requirements - Luminaires for emergency lighting |
| EN 60598-2-25 : 1994 AMD 1 2004 | LUMINAIRES - PART 2-25: PARTICULAR REQUIREMENTS - LUMINAIRES FOR USE IN CLINICAL AREAS OF HOSPITALS AND HEALTH CARE BUILDINGS |
| EN ISO 9680:2014 | Dentistry - Operating lights (ISO 9680:2014) |
| IEC 60598-2-4:2017 | Luminaires - Part 2-4: Particular requirements - Portable general purpose luminaires |
| EN 60598-2-22:2014/AC:2016-09 | LUMINAIRES - PART 2-22: PARTICULAR REQUIREMENTS - LUMINAIRES FOR EMERGENCY LIGHTING (IEC 60598-2-22:2014/COR2:2016) |
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