IEC 60601-2-45:2011+AMD1:2015 CSV
Current
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, English - French
Published date
18-06-2015
Publisher
IEC 60601-2-45:2011+A1:2015 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment. This consolidated version consists of the third edition (2011) and its amendment 1 (2015). 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: 2017. (06/2015)
|
| DocumentType |
Standard
|
| Pages |
105
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| JIS Z 4751-2-45:2017 | Identical |
| GOST R IEC 60601-2-45 : 2014 | Identical |
| NBN EN 60601 2-45 : 2011 AMD 1 2015 | Identical |
| NEN EN IEC 60601-2-45 : 2011 AMD 1 2015 | Identical |
| I.S. EN 60601-2-45:2011 | Identical |
| AS/NZS IEC 60601.2.45:2015 | Identical |
| PN EN 60601-2-45 : 2011 AMD 1 2015 | Identical |
| DIN EN 60601-2-45 : 2017-01 | Identical |
| VDE 0750-2-45 : 2017-01 | Identical |
| UNE-EN 60601-2-45:2011/A1:2015 | Identical |
| BS 5724-2.45(1999) : 1999 | Identical |
| BS EN 60601-2-45 : 2011 | Identical |
| EN 60601-2-45:2011/A1:2015 | Identical |
| NF EN 60601 2-45 : 2011 AMD 1 2015 | Identical |
| UNE-EN 60601-2-45:2002 | Identical |
| GOST IEC 60601-2-45 : 2011 | Identical |
| BS EN 62220-1-2:2007 | Medical electrical equipment. Characteristics of digital X-ray imaging devices Determination of the detective quantum efficiency. Detectors used in mammography |
| 17/30362279 DC : 0 | BS EN 61223-3-6 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-6: ACCEPTANCE AND CONSTANCY TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC TOMOSYNTHESIS MODE OF OPERATION OF MAMMOGRAPHIC X-RAY EQUIPMENT |
| 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 |
| CEI EN 62220-1-2 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-2: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN MAMMOGRAPHY |
| 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 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) |
| BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| 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 |
| BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
| 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 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) |
| I.S. EN 61223-3-2:2008 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT |
| IEC 61223-3-2:2007 | Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| 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) |
| I.S. EN 62220-1-2:2007 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-2: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN MAMMOGRAPHY |
| 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 62220-1-2:2007 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
| 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 62220-1-2:2007 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
| 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) |
| BS EN 61223-3-2:2008 | Evaluation and routine testing in medical imaging departments Acceptance tests. Imaging performance of mammographic X-ray equipment |
| 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 |
| 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 |
| 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 61223-3-2:2008 | Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
| 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 |
| ISO 9236-3:1999 | Photography Sensitometry of screen/film systems for medical radiography Part 3: Determination of sensitometric curve shape, speed and average gradient for mammography |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| IEC 62220-1-2:2007 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
| ISO 12052:2017 | Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management |
| IEC 60613:2010 | Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis |
| ISO 4090:2001 | Photography Medical radiographic cassettes/screens/films and hard-copy imaging films Dimensions and specifications |
| 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 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 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 61223-3-2:2007 | Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| IEC 60664-1:2007 | Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests |
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