I.S. EN IEC 60601-2-1:2021
Current
The latest, up-to-date edition.
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
English
02-08-2021
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.
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 DEVICES
201.104 * LATENCY
201.105 Interfaces
201.106 TREATMENT PLAN retrieval
201.107 Recording of TREATMENT delivery
201.108 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 testing
Annex 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 POINTS
Annex DD (informative) Radiobiology considerations
Bibliography
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