IEC 60601-2-43:2010+AMD1:2017 CSV
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
22-10-2019
IEC 60601-2-43:2010+AMD1:2017+AMD2:2019 CSV
IEC 60601-2-43:2022
IEC 60601-2-43:2022 RLV
English - French
31-05-2017
IEC 60601-2-43:2010+A1:2017 establishes particular basic safety and essential performance requirements for the design and manufacture of X ray equipment for radioscopically guided interventional procedures. It specifies information which is to be provided with such interventional X-ray equipment for the assistance of the responsible organization and operator in managing the radiation risk and equipment failure risk arising from these procedures which could affect patients or staff. This second edition cancels and replaces the first edition published in 2000. This particular standard has been revised to provide a complete set of safety requirements for X-ray equipment for radioscopically guided interventional procedures, based on the third edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a system standard for X-ray equipment designed for the use during interventional procedures using X-ray imaging, whether of prolonged or normal duration. This consolidated version consists of the second edition (2010) and its amendment 1 (2017). Therefore, no need to order amendment in addition to this publication.
Committee |
TC 62/SC 62B
|
DevelopmentNote |
Supersedes IEC 60601-2-32. (11/2012) Stability Date: 2019. (06/2017)
|
DocumentType |
Standard
|
Pages |
227
|
PublisherName |
International Electrotechnical Committee
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Status |
Superseded
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SupersededBy | |
Supersedes |
Standards | Relationship |
NBR IEC 60601-2-43 : 2012 ERRATA 1 2013 | Identical |
VDE 0750-2-43 : 2011 | Identical |
NBN EN 60601 2-43 : 2010 | Identical |
NF EN 60601-2-43 : 2011 | Identical |
DIN EN 60601-2-43 : 2011 | Identical |
BS EN 60601-2-43:2010 | Identical |
NEN EN IEC 60601-2-43 : 2010 C11 2014 | Identical |
GOST R IEC 60601-2-43 : 2013 | Identical |
OVE/ONORM EN 60601-2-43 : 2011 | Identical |
BIS IS 13450-2-43 : 2016 | Identical |
UNE-EN 60601-2-43:2010 | Identical |
JIS Z 4751-2-43:2021 | Identical |
CAN/CSA C22.2 No. 60601.2.43 : 2011(R2016) | Identical |
UNE-EN 60601-2-43:2002 | Identical |
CSA C22.2 No. 60601.2.43 : 2011 | Identical |
PN EN 60601-2-43 : 2010 AC 2014 | Identical |
EN 60601-2-43:2010/A1:2018 | Identical |
16/30342390 DC : 0 | BS EN 60601-2-63:2015/AMENDMENT 1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT |
BS EN 61910-1:2014 | Medical electrical equipment. Radiation dose documentation Radiation dose structured reports for radiography and radioscopy |
06/30107360 DC : 0 | IEC 60601-1-3 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT |
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 |
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 60601-2-46:2016 | Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
EN 62494-1:2008 | Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography |
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 60601-2-54:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
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)) |
I.S. EN 62494-1:2008 | MEDICAL ELECTRICAL EQUIPMENT - EXPOSURE INDEX OF DIGITAL X-RAY IMAGING SYSTEMS - PART 1: DEFINITIONS AND REQUIREMENTS FOR GENERAL RADIOGRAPHY |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
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 |
I.S. EN 60601-1-3:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT |
EN 60601-1-3 : 2008 AMD 11 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013) |
NEMA XR 31:2016 | Standard Attributes on X-ray Equipment for Interventional Procedures |
NEMA XR 27:2013 | X-ray Equipment for Interventional Procedures User Quality Control Mode |
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 ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
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 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 |
I.S. EN 61910-1:2014 | MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION -PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY |
I.S. EN ISO 11073-10418:2014 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01) |
IEC 61910-1:2014 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
UNE-EN 60601-2-54:2010 | Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
16/30342393 DC : 0 | BS EN 60601-2-65:2013/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT |
BS EN 62494-1:2008 | Medical electrical equipment. Exposure index of digital X-ray imaging systems Definitions and requirements for general radiography |
PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
I.S. EN ISO 11073-10406:2012 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012) |
17/30341818 DC : 0 | BS EN 60601-2-54 ED 1.0/A2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
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 |
IEC PAS 61910-1:2007 | Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy |
IEC 60601-2-54:2009+AMD1:2015 CSV | Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy |
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 |
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 |
ISO/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
IEC 62494-1:2008 | Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography |
BS EN 60601-1-3 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008) |
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) |
EN ISO 11073-10406:2012 | Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012) |
CEI EN 62494-1 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - EXPOSURE INDEX OF DIGITAL X-RAY IMAGING SYSTEMS - PART 1: DEFINITIONS AND REQUIREMENTS FOR GENERAL RADIOGRAPHY |
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 |
UNI EN ISO 11073-10406 : 2013 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) |
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 |
BS EN 60601-2-54:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
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 |
EN 60601-2-54:2009/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
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 60601-1:2005+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 61910-1:2014 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
NEMA XR 24-2008 (R2014) | PRIMARY USER CONTROLS FOR INTERVENTIONAL ANGIOGRAPHY X-RAY EQUIPMENT |
IEC 60601-2-54:2009+AMD1:2015 CSV | Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy |
IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
IEC 62220-1:2003 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
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 TR 62348:2012 | Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition |
IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
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