{"id":408063,"date":"2024-10-20T05:28:48","date_gmt":"2024-10-20T05:28:48","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iec-60601-2-12021\/"},"modified":"2024-10-26T09:57:21","modified_gmt":"2024-10-26T09:57:21","slug":"bs-en-iec-60601-2-12021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iec-60601-2-12021\/","title":{"rendered":"BS EN IEC 60601-2-1:2021"},"content":{"rendered":"

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 \u2013 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), \u2013 that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION or ELECTRON RADIATION having \u2022 NOMINAL ENERGY in the range 1 MeV to 50 MeV, \u2022 maximum ABSORBED DOSE RATES between 0,001 Gy x s\u20131 and 1 Gy x s\u20131 at the ERP from the RADIATION SOURCE, and \u2022 REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION SOURCE; and \u2013 intended to be \u2022 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, \u2022 maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and \u2022 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 \u2022 BEAM GATING, and\u2022 ADAPTIVE RADIOTHERAPY.<\/p>\n

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2<\/td>\nundefined <\/td>\n<\/tr>\n
5<\/td>\nAnnex ZA(normative)Normative references to international publicationswith their corresponding European publications <\/td>\n<\/tr>\n
7<\/td>\nEnglish
CONTENTS <\/td>\n<\/tr>\n
10<\/td>\nFOREWORD <\/td>\n<\/tr>\n
13<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
14<\/td>\n201.1 Scope, object and related standards <\/td>\n<\/tr>\n
17<\/td>\n201.2 Normative references
201.3 Terms and definitions <\/td>\n<\/tr>\n
24<\/td>\nFigures
Figure 201.101 \u2013 Flattened area within the radiation field
Tables
Table 201.101 \u2013 Dimensions defining the flattened area according to Figure 201.101 <\/td>\n<\/tr>\n
26<\/td>\n201.4 General requirements
201.5 General requirements for testing me equipment <\/td>\n<\/tr>\n
27<\/td>\n201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents <\/td>\n<\/tr>\n
31<\/td>\nTable 201.102 \u2013 Data required in the technical description to support Clause 201.10 site test compliance <\/td>\n<\/tr>\n
33<\/td>\nTable 201.103 \u2013 Clauses and subclauses in this particular standard that require the provision of information in the accompanying documentation, instructions for use and the technical description <\/td>\n<\/tr>\n
36<\/td>\n201.8 Protection against electrical hazards from me equipment <\/td>\n<\/tr>\n
37<\/td>\n201.9 Protection against mechanical hazards of me equipment and me systems <\/td>\n<\/tr>\n
44<\/td>\n201.10 Protection against unwanted and excessive radiation hazards <\/td>\n<\/tr>\n
64<\/td>\nFigure 201.102 \u2013 Limits of stray X-radiation during electron irradiation <\/td>\n<\/tr>\n
65<\/td>\nTable 201.105 \u2013 Limits of relative surface dose during X-irradiation (see Figure 201.103) <\/td>\n<\/tr>\n
66<\/td>\nFigure 201.103 \u2013 Limits of relative surface dose during X-irradiation <\/td>\n<\/tr>\n
69<\/td>\nFigure 201.104 \u2013 Elevation view \u2013 Application of leakage radiation requirements <\/td>\n<\/tr>\n
72<\/td>\nFigure 201.105 \u2013 24 measurement points for averaging leakage radiation during X-radiation <\/td>\n<\/tr>\n
74<\/td>\nFigure 201.106 \u2013 Limits of leakage radiation through the beam limiting devices during electron irradiation <\/td>\n<\/tr>\n
76<\/td>\nFigure 201.107 \u2013 Measurement points for averaging leakage radiationduring electron irradiation <\/td>\n<\/tr>\n
78<\/td>\nFigure 201.108 \u2013 24 measurement points for averaging leakage radiation outside area M <\/td>\n<\/tr>\n
79<\/td>\nFigure 201.109 \u2013 Me equipment movements and scales <\/td>\n<\/tr>\n
85<\/td>\n201.11 Protection against excessive temperatures and other hazards
201.12 Accuracy of controls and instruments and protection against hazardous outputs <\/td>\n<\/tr>\n
86<\/td>\n201.13 Hazardous situations and fault conditions for me equipment <\/td>\n<\/tr>\n
87<\/td>\n201.15 Construction of me equipment <\/td>\n<\/tr>\n
88<\/td>\n201.17 Electromagnetic compatibility of me equipment and me systems <\/td>\n<\/tr>\n
89<\/td>\n201.101 * Electronic imaging devices (e.g. epid)
201.102 Date and time format <\/td>\n<\/tr>\n
92<\/td>\n201.105 Interfaces <\/td>\n<\/tr>\n
94<\/td>\n201.106 Treatment plan retrieval
201.107 Recording of treatment delivery <\/td>\n<\/tr>\n
97<\/td>\n201.109 Imaging dose delivery
201.110 Operation of me equipment from outside the facility <\/td>\n<\/tr>\n
99<\/td>\nAnnexes <\/td>\n<\/tr>\n
100<\/td>\nAnnex B (informative)Sequence of testing
B.1 General <\/td>\n<\/tr>\n
101<\/td>\nAnnex AA (informative)Particular guidance and rationale
AA.1 General guidance
Table AA.1 \u2013 Items of consideration in the generation of this document <\/td>\n<\/tr>\n
102<\/td>\nTable AA.2 \u2013 Mapping of clauses in edition 3.1 to clauses in this document (excluding Clause 201.10) <\/td>\n<\/tr>\n
104<\/td>\nTable AA.3 \u2013 New clauses in this document <\/td>\n<\/tr>\n
105<\/td>\nTable AA.4 \u2013 Mapping of clauses in edition 3.1 to clauses in this document (Clause 201.10) <\/td>\n<\/tr>\n
106<\/td>\nAA.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
107<\/td>\nFigure AA.1 \u2013 Closed-loop control dose delivery system
Figure AA.2 \u2013 Dynamic dose-positioning <\/td>\n<\/tr>\n
109<\/td>\nAnnex 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\u20112\u20111:2009) <\/td>\n<\/tr>\n
111<\/td>\nAnnex CC (informative)Latency and accuracy of dose delivery between control points
Figure CC.1 \u2013 Diagram to measure the beam gating latency at disabling irradiation <\/td>\n<\/tr>\n
112<\/td>\nFigure CC.2 \u2013 Diagram to measure the beam gating latency at enabling irradiation
Figure CC.3 \u2013 Beam hold and beam restart response times <\/td>\n<\/tr>\n
113<\/td>\nAnnex DD (informative)Radiobiology considerations <\/td>\n<\/tr>\n
114<\/td>\nBibliography <\/td>\n<\/tr>\n
116<\/td>\nIndex of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment – Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2021<\/td>\n120<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":408071,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[144,2641],"product_tag":[],"class_list":{"0":"post-408063","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-60","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/408063","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/408071"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=408063"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=408063"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=408063"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}