CEI EN 60601-2-17 : 2016
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLYCONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
Hardcopy , PDF
English
01-01-2016
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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 |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-40 (09/2001) 2ED 2006 Edition is valid until 14-04-2018. (02/2016) Italian translation of 3ED 2016 Issued on 01/03/2017. (04/2017)
|
| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Standards | Relationship |
| IEC 60601-2-17:2013 | Identical |
| EN 60601-2-17:2015 | 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 60601-2-11:2015 | Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment |
| 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 60601-2-1:2009+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 |
| 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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