I.S. EN 60601-2-1:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
Hardcopy , PDF
05-08-2021
English
01-01-2015
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
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
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
206 Usability
Annexes
Annex B (informative) - Sequence of testing
Annex I (informative) - ME SYSTEMS aspects
Bibliography
Index of defined terms
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 electron accelerators in the range 1 MeV to 50 MeV, used for treatment of patients.
| DevelopmentNote |
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 |
156
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| DIN EN 60601-2-1 : 2016 | Identical |
| BS EN 60601-2-1:2015 | Identical |
| EN 60601-2-1:2015 | Identical |
| SN EN 60601-2-1 : 1998 | Identical |
| UNE-EN 60601-2-1:2017 | Identical |
| NF EN 60601-2-1 : 2016 | Identical |
| EN 61217:2012 | Radiotherapy equipment - Coordinates, movements and scales |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| IEC 60976:2007 | Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| IEC TR 60977:2008 | Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics |
| IEC 61217:2011 | Radiotherapy equipment - Coordinates, movements and scales |
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