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IEC 60601-2-54:2009+AMD1:2015 CSV
Superseded
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Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
10-06-2019
English - French
17-04-2015
IEC 60601-2-54:2009+A1:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54. The contents of the corrigenda of March 2010 and June 2011 have been included in this copy. This consolidated version consists of the first edition (2009) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.
Committee |
TC 62/SC 62B
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DevelopmentNote |
Supersedes IEC 60601-2-32. (11/2012) Stability Date: 2018. (04/2015)
|
DocumentType |
Standard
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Pages |
289
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PublisherName |
International Electrotechnical Committee
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Status |
Superseded
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SupersededBy | |
Supersedes |
Standards | Relationship |
UNE-EN 60601-2-54:2010 | Identical |
PN EN 60601-2-54 : 2009 AMD 1 2015 | Identical |
PN-EN 60601-2-54 : 2009 | Identical |
EN 60601-2-54:2009/A1:2015 | Identical |
NF EN 60601-2-54 : 2009 AMD 1 2015 | Identical |
VDE 0750-2-54 : 2016 | Identical |
NEN EN IEC 60601-2-54 : 2009 AMD 1 2015 | Identical |
BS EN 60601-2-54:2009 | Identical |
NBN EN 60601-2-54 : 2009 AMD 1 2015 | Identical |
I.S. EN 60601-2-54:2009 | Identical |
DIN EN 60601-2-54 : 2016 | Identical |
JIS Z 4751-2-54:2021 | Identical |
13/30247422 DC : 0 | BS EN 62220-1-1 - MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN RADIOGRAPHIC IMAGING |
08/30151689 DC : DRAFT JULY 2008 | BS EN 60601-2-43 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
BS EN 61910-1:2014 | Medical electrical equipment. Radiation dose documentation Radiation dose structured reports for radiography and radioscopy |
NF EN 61910-1 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION -PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY |
EN 60601-2-63:2015 | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
NF EN 60601-2-43 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
EN 60601-2-65:2013 | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
PD IEC/TR 60601-4-1:2017 | Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy |
BS EN 60601-2-65:2013 | Medical electrical equipment Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
I.S. EN 60601-2-65:2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT (IEC 60601-2-65:2012 (EQV)) |
IEC 60601-2-43:2010+AMD1:2017 CSV | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
IEC 62220-1-1:2015 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging |
IEC 60601-2-63:2012+AMD1:2017 CSV | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
NEMA XR 31:2016 | Standard Attributes on X-ray Equipment for Interventional Procedures |
NEMA/MITA XR 30:2016 | Quality Control Tools for Digital Projection Radiography |
BS EN 60601-2-43:2010 | Medical electrical equipment Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures |
16/30342399 DC : 0 | BS EN 60601-2-43:2010/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
EN 62220-1-1:2015 | Medical electrical equipment - Characteristics of digital x-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging |
NF EN 60601-2-63 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT |
I.S. EN 60601-2-63:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRAORAL X-RAY EQUIPMENT |
IEC TR 60601-4-1:2017 | Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy |
I.S. EN 61910-1:2014 | MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION -PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY |
EN 60601-2-43:2010/A1:2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES (IEC 60601-2-43:2010/A1:2017) |
IEC 61910-1:2014 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
BS EN 62220-1-1:2015 | Medical electrical equipment. Characteristics of digital x-ray imaging devices Determination of the detective quantum efficiency. Detectors used in radiographic imaging |
PD IEC/TR 60601-4-3:2015 | Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements |
I.S. EN 62220-1-1:2015 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN RADIOGRAPHIC IMAGING |
I.S. EN 60601-2-43:2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
IEC 60601-2-65:2012+AMD1:2017 CSV | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
I.S. EN 60601-2-65:2013/A1:2020 | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intraoral X-ray equipment (IEC 60601-2-65:2012/A1:2017) |
11/30199851 DC : 0 | BS EN 60601-2-63 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT |
13/30258863 DC : 0 | BS EN 61910-1 ED 1.0 - MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION - PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY |
BS EN 60601-2-63:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
CSA C22.2 No. 60601-2-63 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT |
CEI EN 60601-2-65 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT |
CAN/CSA-C22.2 No. 60601-2-65 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT |
EN 61910-1:2014 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
CAN/CSA C22.2 No. 60601.2.43 : 2011(R2016) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
CSA C22.2 No. 60601.2.43 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
IEC 60601-2-7:1998 | Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators |
IEC 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
IEC 60601-1-10:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
ISO 4090:2001 | Photography Medical radiographic cassettes/screens/films and hard-copy imaging films Dimensions and specifications |
IEC 60601-2-28:2017 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
IEC 62220-1:2003 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
IEC 60601-2-28 : 3.0 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
IEC 60580:2000 | Medical electrical equipment - Dose area product meters |
IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
IEC 60601-2-43:2010+AMD1:2017 CSV | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
IEC 60627:2013 | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
IEC 60806:1984 | Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis |
IEC 61267:2005 | Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics |
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