🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN IEC 60601-2-1:2021

BS EN IEC 60601-2-1:2021

$215.11

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

Published By Publication Date Number of Pages
BSI 2021 120
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

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
2 undefined
5 Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
7 English
CONTENTS
10 FOREWORD
13 INTRODUCTION
14 201.1 Scope, object and related standards
17 201.2 Normative references
201.3 Terms and definitions
24 Figures
Figure 201.101 – Flattened area within the radiation field
Tables
Table 201.101 – Dimensions defining the flattened area according to Figure 201.101
26 201.4 General requirements
201.5 General requirements for testing me equipment
27 201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
31 Table 201.102 – Data required in the technical description to support Clause 201.10 site test compliance
33 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
36 201.8 Protection against electrical hazards from me equipment
37 201.9 Protection against mechanical hazards of me equipment and me systems
44 201.10 Protection against unwanted and excessive radiation hazards
64 Figure 201.102 – Limits of stray X-radiation during electron irradiation
65 Table 201.105 – Limits of relative surface dose during X-irradiation (see Figure 201.103)
66 Figure 201.103 – Limits of relative surface dose during X-irradiation
69 Figure 201.104 – Elevation view – Application of leakage radiation requirements
72 Figure 201.105 – 24 measurement points for averaging leakage radiation during X-radiation
74 Figure 201.106 – Limits of leakage radiation through the beam limiting devices during electron irradiation
76 Figure 201.107 – Measurement points for averaging leakage radiationduring electron irradiation
78 Figure 201.108 – 24 measurement points for averaging leakage radiation outside area M
79 Figure 201.109 – Me equipment movements and scales
85 201.11 Protection against excessive temperatures and other hazards
201.12 Accuracy of controls and instruments and protection against hazardous outputs
86 201.13 Hazardous situations and fault conditions for me equipment
87 201.15 Construction of me equipment
88 201.17 Electromagnetic compatibility of me equipment and me systems
89 201.101 * Electronic imaging devices (e.g. epid)
201.102 Date and time format
92 201.105 Interfaces
94 201.106 Treatment plan retrieval
201.107 Recording of treatment delivery
97 201.109 Imaging dose delivery
201.110 Operation of me equipment from outside the facility
99 Annexes
100 Annex B (informative)Sequence of testing
B.1 General
101 Annex AA (informative)Particular guidance and rationale
AA.1 General guidance
Table AA.1 – Items of consideration in the generation of this document
102 Table AA.2 – Mapping of clauses in edition 3.1 to clauses in this document (excluding Clause 201.10)
104 Table AA.3 – New clauses in this document
105 Table AA.4 – Mapping of clauses in edition 3.1 to clauses in this document (Clause 201.10)
106 AA.2 Rationale for particular clauses and subclauses
107 Figure AA.1 – Closed-loop control dose delivery system
Figure AA.2 – Dynamic dose-positioning
109 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)
111 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
112 Figure CC.2 – Diagram to measure the beam gating latency at enabling irradiation
Figure CC.3 – Beam hold and beam restart response times
113 Annex DD (informative)Radiobiology considerations
114 Bibliography
116 Index of defined terms

Related products

BS EN IEC 60601-2-1:2021
$215.11