BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Hardcopy , PDF
29-12-2021
English
31-10-2016
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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
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, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for treatment of PATIENTS.
| Committee |
CH/62/3
|
| DevelopmentNote |
Supersedes 01/561347 DC, 95/563441 DC, BS 5724-2.1(1989) and BS 5724-2.1:SUPP1(1991). (08/2003) 1998 Edition along with it's amendment remains active & will be withdrawn on 15/09/2018. Supersedes BS 5724-2.1(1998), 08/30168475 DC & 11/30253577 DC. (11/2015)
|
| DocumentType |
Standard
|
| Pages |
70
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60601-2-1:2009+AMD1:2014 CSV | Identical |
| I.S. EN 60601-2-1:2015 | Identical |
| SN EN 60601-2-1 : 1998 | Identical |
| DIN EN 60601-2-1 : 2016 | Identical |
| UNE-EN 60601-2-1:2017 | Identical |
| EN 60601-2-1:2015 | Identical |
| NF EN 60601-2-1 : 2016 | Identical |
| BS 5724-3.1:Supplement No. 1:1990 | Medical electrical equipment. Particular requirements for performance Methods of declaring functional performance characteristics of medical electron accelerators in the range 1 MeV to 50 MeV. Guide to functional performance values |
| 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 TR 60977:2008 | Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| IEC 61217:2011 | Radiotherapy equipment - Coordinates, movements and scales |
| EN 60976:2007 | Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
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