BS EN 60601-2-17:2015
Current
The latest, up-to-date edition.
Medical electrical equipment Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
Hardcopy , PDF
English
06-30-2015
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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
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZ (informative) - Coverage of Essential
Requirements of EU Directives
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE Of automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT, hereafter referred to as ME EQUIPMENT.
| Committee |
CH/62/3
|
| DevelopmentNote |
Renumbers and supersedes BS 5724-2.17(1990) 1996 Version incorporates amendment 9281 to BS 5724-2.17(1990) Supersedes 02/564070 DC (05/2004) 2004 Edition remains active & will be withdrawn on 14/04/2018. Supersedes 10/30206488 DC. (06/2015) Supersedes BS 5724-2.17:SUPP1(1996). (08/2015)
|
| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| Standards | Relationship |
| UNE-EN 60601-2-17:2005 | Identical |
| SN EN 60601-2-17 : 1996 AMD 1 1996 | Identical |
| I.S. EN 60601-2-17:2015 | Identical |
| IEC 60601-2-17:2013 | Identical |
| EN 60601-2-17:2015 | Identical |
| NF EN 60601-2-17 : 2015 | Identical |
| BS 5724-2.17(1990) : 1990 AMD 9281 | Identical |
| 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) |
| EN 61217:2012 | Radiotherapy equipment - Coordinates, movements and scales |
| EN 60601-2-11:2015 | Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment |
| EN 60601-2-28:2010 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| IEC 60601-1:2005+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 |
| EN 61005:2017 | 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 |
| EN 62083:2009 | MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| 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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