IEC 60601-2-17:2013
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
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English - French
27-11-2013
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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
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
for ME EQUIPMENT
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 A (informative) - General guidance and rationale
Bibliography
Index of defined terms used in this particular standard
IEC 60601-2-17:2013 applies to the basic safety and essential performance of automatically-controlled Brachytherapy Afterloading Medical Equipment. This standard does not specify requirements for sealed radioactive sources. This third edition cancels and replaces the second edition, published in 2004. Consideration has been given to new IEC standards, amendments to existing IEC standards, developments in technology and clinical usage, and various hazards encountered and envisaged since the preparation of the first and second editions. This edition constitutes a technical revision which brings this standard in line with IEC 60601-1:2005+A1:2012 and its collateral standards.
| DevelopmentNote |
Stability Date: 2019. (10/2017)
|
| DocumentType |
Standard
|
| Pages |
92
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| SN EN 60601-2-17:2015 | Identical |
| NBN EN 60601 2-17 : 1996 | Identical |
| NEN EN IEC 60601-2-17 : 2015 | Identical |
| AS/NZS IEC 60601.2.17:2015 | Identical |
| PN EN 60601-2-17 : 2015 | Identical |
| VDE 0750-2-17 : 2016 | Identical |
| IS 13450 : Part 2 : Sec 17 : 2018 | Identical |
| BS EN 60601-2-17:2015 | Identical |
| UNE-EN 60601-2-17:2005 | Identical |
| CEI EN 60601-2-17 : 2016 | Identical |
| EN 60601-2-17:2015 | Identical |
| NF EN 60601-2-17 : 2015 | Identical |
| UNE-EN 60601-2-17:2015 | Identical |
| CSA C22.2 No. 601.2.17 :1994 | Identical |
| BS 5724-2.17(1990) : 1990 AMD 9281 | Identical |
| SN EN 60601-2-17 : 1996 AMD 1 1996 | Identical |
| CSA C22.2.601.2.17A : 2001 | Identical |
| PNE-FprEN 60601-2-17 | Identical |
| NEN 10601-2-17 : 1996 AMD 1 1996 | Identical |
| DIN EN 60601-2-17 : 2016 | Identical |
| GOST R IEC 60601-2-17 : 2010 | Identical |
| NFC 74 210 : 1992 | Identical |
| DIN 6853-1 : 92 AMD 1 98 | Corresponds |
| 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) |
| 12/30242781 DC : 0 | BS EN 61331-2 - PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 2: TRANSLUCENT PROTECTIVE PLATES |
| UNE-EN 61331-2:2015 | Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates |
| 16/30216785 DC : 0 | BS EN 62667 - MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS |
| CEI EN 62274 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
| 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 |
| BS EN 61331-2:2014 | Protective devices against diagnostic medical X-radiation Translucent protective plates |
| 02/564070 DC : DRAFT SEP 2002 | BS EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE SAFETY OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
| BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
| I.S. EN 61331-2:2014 | PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 2: TRANSLUCENT PROTECTIVE PLATES |
| IEC 60601-2-8:2010+AMD1:2015 CSV | Medical electrical equipment - Part 2-8: Particular requirements forthe basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV |
| I.S. EN 62274:2005 | MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
| 14/30311404 DC : DRAFT AUG 2014 | BS EN 60601-2-8 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-8: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF THERAPEUTIC X-RAY EQUIPMENT OPERATING IN THE RANGE 10 KV TO 1 MV |
| BS EN 60601-2-8 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-8: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF THERAPEUTIC X-RAY EQUIPMENT OPERATING IN THE RANGE 10 KV TO 1 MV |
| 07/30143885 DC : 0 | BS ISO 21439 - CLINICAL DOSIMETRY - BETA RADIATION SOURCES FOR BRACHYTHERAPY |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| BS ISO 21439:2009 | Clinical dosimetry. Beta radiation sources for brachytherapy |
| BS EN 62274:2005 | Medical electrical equipment. Safety of radiotherapy record and verify systems |
| BS EN IEC 62667:2018 | Medical electrical equipment. Medical light ion beam equipment. Performance characteristics |
| I.S. EN IEC 62667:2018 | MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS |
| 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) |
| EN IEC 62667:2018 | Medical electrical equipment - Medical light ion beam equipment - Performance characteristics |
| I.S. EN 60601-2-8:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-8: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF THERAPEUTIC XRAY EQUIPMENT OPERATING IN THE RANGE 10 KV TO 1 MV |
| EN 60601-2-8:2015/A1:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-8: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF THERAPEUTIC X-RAY EQUIPMENT OPERATING IN THE RANGE 10 KV TO 1 MV (IEC 60601-2-8:2010/A1:2015) |
| IEC 62274:2005 | Medical electrical equipment - Safety of radiotherapy record and verify systems |
| IEC 61331-2:2014 | Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates |
| ISO/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| 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 ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| UNI EN ISO 11073-10406 : 2013 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) |
| ISO 21439:2009 | Clinical dosimetry — Beta radiation sources for brachytherapy |
| EN 62274:2005 | Medical electrical equipment - Safety of radiotherapy record and verify systems |
| EN 61331-2:2014 | Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates |
| 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 61005:2014 | Radiation protection instrumentation - Neutron ambient dose equivalent (rate) meters |
| IEC 60601-2-8:2010+AMD1:2015 CSV | Medical electrical equipment - Part 2-8: Particular requirements forthe basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV |
| IEC 62083:2009 | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| 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 60601-2-1:2009+AMD1:2014 CSV | Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
| IEC 61217:2011 | Radiotherapy equipment - Coordinates, movements and scales |
| IEC 60601-2-11:2013 | Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment |
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