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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
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 02-08-2021
Publisher: National Standards Authority of Ireland
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.Only cited Standards give presumption of conformance to New Approach Directives/Regulations.Dates of withdrawal of national standards are available from NSAI.
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 201.101 * ELECTRONIC IMAGING DEVICES (e.g. EPID) 201.102 Date and time format 201.103 EXTERNAL MONITORING DEVICES201.104 * LATENCY 201.105 Interfaces 201.106 TREATMENT PLAN retrieval 201.107 Recording of TREATMENT delivery201.108 ADAPTIVE RADIOTHERAPY 201.109 Imaging dose delivery 201.110 Operation of ME EQUIPMENT from outside the facility 206 USABILITY Annexes Annex B (informative) Sequence of testingAnnex AA (informative) Particular guidance and rationale Annex BB (informative) Electronic imaging devices (e.g. epid) Annex CC (informative) Latency and accuracy of dose delivery between CONTROL POINTSAnnex DD (informative) Radiobiology considerations Bibliography
This part of IEC 60601 applies 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.
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