I.S. EN 60601-2-11:2015
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-11: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF GAMMA BEAM THERAPY EQUIPMENT
Hardcopy , PDF
English
01-01-2015
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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 of
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
201.14 PROGRAMMABLE ELECTRICAL MEDICAL
SYSTESM (PEMS)
201.15 Construction of ME EQUIPMENT ME SYSTEMS
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
and ME SYSTEMS 201
Annexes
Annex B (informative) - Sequence of testing
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 GAMMA BEAM THERAPY EQUIPMENT, including MULTI-SOURCE STEREOTACTIC RADIOTHERAPY equipment, hereafter referred to as ME EQUIPMENT.
| DevelopmentNote |
Supersedes I.S. HD 395-2-11. (11/2004) For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
112
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 60601-2-11:2015 | Identical |
| DIN EN 60601-2-11 : 2016 | Identical |
| SN EN 60601-2-11 : 1997 | Identical |
| BS EN 60601-2-11:2015 | Identical |
| UNE-EN 60601-2-11:1999 | Identical |
| EN 61217:2012 | Radiotherapy equipment - Coordinates, movements and scales |
| 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) |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| 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 61217:2011 | Radiotherapy equipment - Coordinates, movements and scales |
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