EN 60601-2-8:2015/A1:2016
Current
The latest, up-to-date edition.
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)
08-01-2016
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 SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
and ME SYSTEMS
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 therapeutic X-RAY EQUIPMENT with NOMINAL X-RAY TUBE VOLTAGES in the range 10 kV to 1 MV when connected to alternating current SUPPLY MAINS, hereafter referred to as ME EQUIPMENT.
| Committee |
TC 62
|
| DevelopmentNote |
To be read in conjunction with EN 60601-1. (05/2001) Supersedes HD 395.2.8. (06/2005)
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN 60601 2-8 : 2015 AMD 1 2016 | Identical |
| BS EN 60601-2-8 : 2015 | Identical |
| UNE EN 60601-2-8 : 2001 | Identical |
| PN EN 60601-2-8 : 2015 AMD 1 2016 | Identical |
| NEN EN IEC 60601-2-8 : 2015 AMD 1 2016 | Identical |
| CEI EN 60601-2-8 : 2016 | Identical |
| SN EN 60601-2-8 : 2015 + A1 2016 | Identical |
| NBN EN 60601 2-8 : 2015 AMD 1 2016 | Identical |
| VDE 0750-2-8 : 2016 | Identical |
| DIN EN 60601-2-8 : 2016 | Identical |
| IEC 60601-2-8:2010+AMD1:2015 CSV | Identical |
| I.S. EN 60601-2-8:2015 | Identical |
| IEC 60601-2-8:2010/AMD1:2015 | Identical |
| BS EN 60601-2-8:2015+A1:2016 | Identical |
| UNE-EN 60601-2-8:2001 | Identical |
| PNE-EN 60601-2-8:2010/FprA1 | Identical |
| CEI EN 60731 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY |
| I.S. EN 60601-2-17:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
| BS EN 60731:2012 | Medical electrical equipment. Dosimeters with ionization chambers as used in radiotherapy |
| CEI EN 60601-2-17 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLYCONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
| BS EN 60601-2-17:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment |
| I.S. EN 60731:2012 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY (IEC 60731:2011 (EQV)) |
| EN 60731:2012 | Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| EN 60601-2-17:2015 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment |
| EN 61217:2012 | Radiotherapy equipment - Coordinates, movements and scales |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| 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 60601-2-17:2013 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment |
| IEC 61217:2011 | Radiotherapy equipment - Coordinates, movements and scales |
| ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
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