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BS EN IEC 60601-2-1:2021 – TC

BS EN IEC 60601-2-1:2021 – TC

$280.87

Tracked Changes. Medical electrical equipment – Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

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BSI 2021 278
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IEC 60601-2-1:2020 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. NOTE 1 While ELECTRON ACCELERATORS used for TREATMENT of PATIENTS are always ME EQUIPMENT, there are times in this document where they are referred to as EXTERNAL BEAM EQUIPMENT (EBE). Usage of EBE does not remove the requirements placed on the ME EQUIPMENT but is meant to clarify that the ME EQUIPMENT being discussed is the EBE and not some other ME EQUIPMENT that may be part of the system configuration. This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies to the manufacture and some installation aspects of ELECTRON ACCELERATORS and their included equipment used to increase the precision, accuracy and volumetric targeting of the TREATMENT delivery – intended for RADIOTHERAPY in medical practice, including those in which the selection and DISPLAY of TREATMENT PARAMETERS can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), – that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION or ELECTRON RADIATION having • NOMINAL ENERGY in the range 1 MeV to 50 MeV, • maximum ABSORBED DOSE RATES between 0,001 Gy x s–1 and 1 Gy x s–1 at the ERP from the RADIATION SOURCE, and • REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION SOURCE; and – intended to be • for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS appropriately licensed or having the required skills for a particular medical application, for particular SPECIFIED clinical purposes, • maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and • subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED PERSON. IEC 60601-2-1:2020 cancels and replaces the third edition published in 2009 and Amendment 1:2014. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with the new relevant collateral standards; b) addition of computer interface and control; c) addition of new technologies in RADIOTHERAPY, including • BEAM GATING, and• ADAPTIVE RADIOTHERAPY.

PDF Catalog

PDF Pages PDF Title
160 undefined
163 Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
165 English
CONTENTS
168 FOREWORD
171 INTRODUCTION
172 201.1 Scope, object and related standards
175 201.2 Normative references
201.3 Terms and definitions
182 Figures
Figure 201.101 – Flattened area within the radiation field
Tables
Table 201.101 – Dimensions defining the flattened area according to Figure 201.101
184 201.4 General requirements
201.5 General requirements for testing me equipment
185 201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
189 Table 201.102 – Data required in the technical description to support Clause 201.10 site test compliance
191 Table 201.103 – Clauses and subclauses in this particular standard that require the provision of information in the accompanying documentation, instructions for use and the technical description
194 201.8 Protection against electrical hazards from me equipment
195 201.9 Protection against mechanical hazards of me equipment and me systems
202 201.10 Protection against unwanted and excessive radiation hazards
222 Figure 201.102 – Limits of stray X-radiation during electron irradiation
223 Table 201.105 – Limits of relative surface dose during X-irradiation (see Figure 201.103)
224 Figure 201.103 – Limits of relative surface dose during X-irradiation
227 Figure 201.104 – Elevation view – Application of leakage radiation requirements
230 Figure 201.105 – 24 measurement points for averaging leakage radiation during X-radiation
232 Figure 201.106 – Limits of leakage radiation through the beam limiting devices during electron irradiation
234 Figure 201.107 – Measurement points for averaging leakage radiationduring electron irradiation
236 Figure 201.108 – 24 measurement points for averaging leakage radiation outside area M
237 Figure 201.109 – Me equipment movements and scales
243 201.11 Protection against excessive temperatures and other hazards
201.12 Accuracy of controls and instruments and protection against hazardous outputs
244 201.13 Hazardous situations and fault conditions for me equipment
245 201.15 Construction of me equipment
246 201.17 Electromagnetic compatibility of me equipment and me systems
247 201.101 * Electronic imaging devices (e.g. epid)
201.102 Date and time format
250 201.105 Interfaces
252 201.106 Treatment plan retrieval
201.107 Recording of treatment delivery
255 201.109 Imaging dose delivery
201.110 Operation of me equipment from outside the facility
257 Annexes
258 Annex B (informative)Sequence of testing
B.1 General
259 Annex AA (informative)Particular guidance and rationale
AA.1 General guidance
Table AA.1 – Items of consideration in the generation of this document
260 Table AA.2 – Mapping of clauses in edition 3.1 to clauses in this document (excluding Clause 201.10)
262 Table AA.3 – New clauses in this document
263 Table AA.4 – Mapping of clauses in edition 3.1 to clauses in this document (Clause 201.10)
264 AA.2 Rationale for particular clauses and subclauses
265 Figure AA.1 – Closed-loop control dose delivery system
Figure AA.2 – Dynamic dose-positioning
267 Annex BB (informative)Electronic imaging devices (e.g. epid)
BB.1 General guidance
BB.2 Electronic imaging devices (e.g. epid) (Clause 201.101 of IEC 60601‑2‑1:2009)
269 Annex CC (informative)Latency and accuracy of dose delivery between control points
Figure CC.1 – Diagram to measure the beam gating latency at disabling irradiation
270 Figure CC.2 – Diagram to measure the beam gating latency at enabling irradiation
Figure CC.3 – Beam hold and beam restart response times
271 Annex DD (informative)Radiobiology considerations
272 Bibliography
274 Index of defined terms

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BS EN IEC 60601-2-1:2021 - TC
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