EN IEC 60601-2-1:2021
(Main)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
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
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.
Medizinische elektrische Geräte - Teil 2-1: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektronenbeschleunigern im Bereich von 1 MeV bis 50 MeV
Appareils électromédicaux - Partie 2-1: Exigences particulières pour la sécurité de base et les performances essentielles des accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV
L'IEC 60601-2-1:2020 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ACCELERATEURS D'ELECTRONS, désignés ci-après sous le terme APPAREILS EM, dans la gamme de 1 MeV à 50 MeV, et utilisés pour le TRAITEMENT des PATIENTS. NOTE 1 Même si les ACCELERATEURS D'ELECTRONS utilisés pour le TRAITEMENT des PATIENTS sont toujours des APPAREILS EM, ils sont parfois désignés par le terme APPAREIL DE RADIOTHERAPIE EXTERNE (EBE) dans le présent document. L'utilisation du terme EBE ne supprime pas les exigences relatives aux APPAREILS EM; l'objet est de préciser que l'APPAREIL EM examiné est l'EBE et non un autre APPAREIL EM qui peut faire partie de la configuration du système. La présente norme particulière, associée à des ESSAIS DE TYPE et à des ESSAIS SUR LE SITE, s'applique à la fabrication et à certains aspects de l'installation des ACCELERATEURS D'ELECTRONS et de leurs appareils utilisés pour améliorer la précision, l'exactitude et le ciblage volumétrique pendant la délivrance du TRAITEMENT – qui sont destinés à la RADIOTHERAPIE en médecine, y compris ceux dont la sélection et l'AFFICHAGE des PARAMETRES DE TRAITEMENT peuvent être contrôlés automatiquement par des SOUS-SYSTEMES ELECTRONIQUES PROGRAMMABLES (SSEP), – qui, en CONDITIONS NORMALES et en UTILISATION NORMALE, fournissent un FAISCEAU DE RAYONNEMENT composé d'un RAYONNEMENT X ou d'un RAYONNEMENT ELECTRONIQUE dont: • l'ENERGIE NOMINALE est comprise dans la gamme de 1 MeV à 50 MeV, • les DEBITS DE DOSE ABSORBEE maximaux sont compris entre 0,001 Gy × s–1et 1 Gy × s–1 mesurés à l'ERP de la SOURCE DE RAYONNEMENT, et • les DISTANCES DE TRAITEMENT DE REFERENCE (DTR) sont comprises entre 0,5 m et 2 m de la SOURCE DE RAYONNEMENT; et – qui sont destinés à • une UTILISATION NORMALE, sous la responsabilité de l'ORGANISME RESPONSABLE par des PERSONNES QUALIFIEES dûment agréées ou qui ont les compétences nécessaires pour une utilisation médicale particulière, pour des applications cliniques SPECIFIEES, • être entretenus selon les recommandations données dans les INSTRUCTIONS D'UTILISATION, et • être vérifiés périodiquement par une PERSONNE QUALIFIEE selon un programme d'ASSURANCE QUALITE portant sur le contrôle des performances et de l'étalonnage. L'IEC 60601-2-1:2020 annule et remplace la troisième édition parue en 2009 et l'Amendement 1:2014. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) harmonisation par rapport aux nouvelles normes collatérales pertinentes; b) ajout de l'interface et du contrôle informatiques; c) ajout des nouvelles technologies de RADIOTHERAPIE, notamment • le DECLENCHEMENT DU FAISCEAU, et • la RADIOTHERAPIE ADAPTATIVE.
Medicinska električna oprema - 2-1. del: Posebne zahteve za osnovno varnost in bistvene lastnosti elektronskih pospeševalnikov v območju od 1 MeV do 50 MeV (IEC 60601-2-1:2020)
General Information
Relations
Overview - EN IEC 60601-2-1:2021 (IEC 60601-2-1:2020)
EN IEC 60601-2-1:2021 specifies particular requirements for the basic safety and essential performance of medical electrical equipment (ME equipment) that are electron accelerators used for radiotherapy. It applies to external beam equipment (EBE) delivering X‑radiation or electron radiation with nominal energies from 1 MeV to 50 MeV, maximum absorbed dose rates between 0.001 Gy·s⁻¹ and 1 Gy·s⁻¹, and reference treatment distances (RTDs) from 0.5 m to 2 m. This edition (aligned to IEC 60601-2-1:2020) updates the previous edition and adds coverage for computer interfaces, beam gating and adaptive radiotherapy.
Key topics and technical requirements
- Scope and safety objectives: Defines requirements addressing both BASIC SAFETY and ESSENTIAL PERFORMANCE for electron accelerators used in patient treatment.
- Type tests and site tests: Requirements for manufacture verification (type testing) and installation checks (site testing) to ensure performance and safety in clinical settings.
- Radiation protection: Limits and controls for unwanted or excessive radiation, stray X‑radiation, beam characteristics and flattening within the radiation field.
- Control and interfaces: Requirements for programmable electronic subsystems (PESS), computer interfaces, data transfer, verification of treatment parameters, and latency/accuracy considerations.
- New technologies: Specific guidance for beam gating (synchronizing beam delivery with patient motion) and adaptive radiotherapy (offline, online, and real‑time workflows).
- Usability and documentation: Marking, instructions for use, maintenance recommendations, alarm systems, and human factors/usability considerations.
- Quality assurance (QA) & calibration: Expectations for regular QA, calibration checks and operation by qualified personnel under a responsible organization.
Practical applications and users
Who uses this standard:
- Manufacturers of electron accelerators and associated subsystems - to design, test and CE/market equipment compliant with EN IEC 60601-2-1.
- Medical physicists and clinical engineers - for acceptance testing, commissioning, QA programs, and site tests.
- Hospital biomedical engineering teams - for maintenance, calibration and safe operation procedures.
- Regulatory bodies and test laboratories - for conformity assessment, certification and auditing of radiotherapy equipment.
Why it matters:
- Ensures patient and staff safety, consistent treatment accuracy, and reliable integration of modern control systems (PESS, imaging, gating, adaptive workflows) into radiotherapy practice.
Related standards
Relevant collateral and particular standards referenced include:
- IEC 60601-1 (general requirements for basic safety and essential performance)
- IEC 60601-1-2 (EMC)
- IEC 60601-2-68 (image‑guided radiotherapy equipment)
- IEC 61217 (radiotherapy coordinates, movements and scales)
- IEC 62366-1 (usability)
Keywords: EN IEC 60601-2-1:2021, electron accelerators, radiotherapy safety, beam gating, adaptive radiotherapy, medical electrical equipment, PESS, type tests, site tests, QA.
Frequently Asked Questions
EN IEC 60601-2-1:2021 is a standard published by CLC. Its full title is "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". This standard covers: 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.
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.
EN IEC 60601-2-1:2021 is classified under the following ICS (International Classification for Standards) categories: 11.040.60 - Therapy equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN IEC 60601-2-1:2021 has the following relationships with other standards: It is inter standard links to EN 60601-2-1:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN IEC 60601-2-1:2021 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/295. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN 60601-2-1:2015
Medicinska električna oprema - 2-1. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti elektronskih pospeševalnikov v območju od 1 MeV do 50 MeV
(IEC 60601-2-1:2020)
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 (IEC
60601-2-1:2020)
Medizinische elektrische Geräte - Teil 2-1: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Elektronenbeschleunigern im
Bereich von 1 MeV bis 50 MeV (IEC 60601-2-1:2020)
Appareils électromédicaux - Partie 2-1: Exigences particulières de sécurité de base et de
performances essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à
50 MeV (IEC 60601-2-1:2020)
Ta slovenski standard je istoveten z: EN IEC 60601-2-1:2021
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60601-2-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2021
ICS 11.040.60 Supersedes EN 60601-2-1:2015 and all of its
amendments and corrigenda (if any)
English Version
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
(IEC 60601-2-1:2020)
Appareils électromédicaux - Partie 2-1: Exigences Medizinische elektrische Geräte - Teil 2-1: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des accélérateurs d'électrons dans la gamme wesentlichen Leistungsmerkmale von
de 1 MeV à 50 MeV Elektronenbeschleunigern im Bereich von 1 MeV bis 50
(IEC 60601-2-1:2020) MeV
(IEC 60601-2-1:2020)
This European Standard was approved by CENELEC on 2020-12-02. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-1:2021 E
European foreword
The text of document 62C/770/FDIS, future edition 4 of IEC 60601-2-1, prepared by SC 62C
"Equipment for radiotherapy, nuclear medicine and radiation dosimetry" of IEC/TC 62 "Electrical
equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN IEC 60601-2-1:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-01-16
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-07-16
document have to be withdrawn
This document supersedes EN 60601-2-1:2015 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
Endorsement notice
The text of the International Standard IEC 60601-2-1:2020 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-1-3:2008 NOTE Harmonized as EN 60601-1-3:2008 (not modified)
IEC 60601-1-3:2008/A1:2013 NOTE Harmonized as EN 60601-1-3:2008/A1:2013 (not modified)
IEC 60601-1-9:2007 NOTE Harmonized as EN 60601-1-9:2008 (not modified)
IEC 60601-1-9:2007/A1:2013 NOTE Harmonized as EN 60601-1-9:2008/A1:2013 (not modified)
IEC 60601-1-10:2007 NOTE Harmonized as EN 60601-1-10:2008 (not modified)
IEC 60601-1-10:2007/A1:2013 NOTE Harmonized as EN 60601-1-10:2008/A1:2015 (not modified)
IEC 60601-2-11:2013 NOTE Harmonized as EN 60601-2-11:2015 (not modified)
IEC 60601-2-17:2013 NOTE Harmonized as EN 60601-2-17:2015 (not modified)
IEC 60601-2-64:2014 NOTE Harmonized as EN 60601-2-64:2015 (not modified)
IEC 60976:2007 NOTE Harmonized as EN 60976:2007 (not modified)
IEC 62083:2009 NOTE Harmonized as EN 62083:2009 (not modified)
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified)
IEC 62680-2-1:2015 NOTE Harmonized as EN 62680-2-1:2015 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
The Annex ZA of EN 60601-1:2006/A1:2013 applies with the following replacements:
Publication Year Title EN/HD Year
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements
and tests
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral standard:
Usability
+ A1 2013 + A1 2015
The Annex ZA of EN 60601-1:2006/A1:2013 applies with the following additions:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: General EN 60601-1 2006
requirements for basic safety and essential
performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
IEC 60601-2-68 2014 Electrical medical equipment - Part 2-68: EN 60601-2-68 2015
Particular requirements for the basic safety
and essential performance of X-ray-based
image-guided radiotherapy equipment for use
with electron accelerators, light ion beam
therapy equipment and radionuclide beam
therapy equipment
IEC 61000-4-3 - Electromagnetic compatibility (EMC) - Part 4-3 EN IEC 61000-4-3 -
: Testing and measurement techniques -
Radiated, radio-frequency, electromagnetic
field immunity test
Publication Year Title EN/HD Year
IEC 61217 2011 Radiotherapy equipment - Coordinates, EN 61217 2012
movements and scales
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
CISPR 11 - Industrial, scientific and medical equipment - EN 55011 -
Radio-frequency disturbance characteristics -
Limits and methods of measurement
IEC 60601-2-1 ®
Edition 4.0 2020-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
Appareils électromédicaux –
Partie 2-1: Exigences particulières pour la sécurité de base et les performances
essentielles des accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-8942-6
– 2 – IEC 60601-2-1:2020 © IEC 2020
CONTENTS
FOREWORD . 5
INTRODUCTION . 8
201.1 Scope, object and related standards . 9
201.1.1 Scope . 9
201.1.2 Object . 10
201.1.3 Collateral standards . 10
201.1.4 Particular standards . 11
201.2 Normative references . 12
201.3 Terms and definitions . 12
201.4 General requirements . 21
201.5 General requirements for testing ME EQUIPMENT . 21
201.5.1 TYPE TESTS . 21
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 22
201.7 ME EQUIPMENT identification, marking and documents . 22
201.7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts . 23
201.7.4 Marking of controls and instruments . 23
201.7.9 ACCOMPANYING DOCUMENTS. 25
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 31
201.8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 31
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 32
201.9.7 Pressure vessels and parts subject to pneumatic and hydraulic pressure . 38
201.9.8 MECHANICAL HAZARDS associated with support systems . 38
201.10 Protection against unwanted and excessive RADIATION HAZARDS . 39
201.10.2 Alpha, beta, gamma, neutron and other particle RADIATION . 39
201.10.101 ME EQUIPMENT intended to produce therapeutic X-RADIATION and
ELECTRON RADIATION . 39
201.11 Protection against excessive temperatures and other HAZARDS . 80
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 80
201.12.3 ALARM SYSTEMS . 80
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 81
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 81
201.14.101 PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS) . 81
201.15 Construction of ME EQUIPMENT . 82
201.16 ME SYSTEMS . 82
201.16.2 ACCOMPANYING DOCUMENTS of an ME SYSTEM . 82
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 83
201.17.101 Additional requirements . 83
201.17.102 Radio-frequency EMISSIONS . 83
201.17.103 IMMUNITY to radio-frequency electromagnetic fields . 83
201.101 * ELECTRONIC IMAGING DEVICES (e.g. EPID) . 84
201.102 Date and time format . 84
201.103 EXTERNAL MONITORING DEVICES . 84
201.103.1 Selection, VERIFICATION, and DISPLAY of EXTERNAL MONITORING DEVICES . 84
201.103.2 BEAM GATING . 85
IEC 60601-2-1:2020 © IEC 2020 – 3 –
201.104 * LATENCY . 86
201.105 Interfaces . 87
201.105.1 Correctness of data transfer . 87
201.105.2 VERIFICATION of data coherence and selection of TREATMENT
PARAMETERS . 87
201.105.3 Interface data requirements . 88
201.106 TREATMENT PLAN retrieval . 89
201.107 Recording of TREATMENT delivery. 89
201.108 ADAPTIVE RADIOTHERAPY . 90
201.108.1 OFFLINE ADAPTIVE RADIOTHERAPY . 90
201.108.2 ONLINE ADAPTIVE RADIOTHERAPY . 91
201.108.3 REAL-TIME ADAPTIVE RADIOTHERAPY . 91
201.109 Imaging dose delivery . 92
201.110 Operation of ME EQUIPMENT from outside the facility . 92
206 USABILITY . 93
206.101 Usability of ELECTRON ACCELERATORS . 93
Annexes . 94
Annex B (informative) Sequence of testing. 95
B.1 General . 95
Annex AA (informative) Particular guidance and rationale . 96
AA.1 General guidance . 96
AA.1.1 Overview . 96
AA.1.2 Mapping of the clauses in IEC 60601‑2‑1:2009 and
IEC 60601‑2‑1:2009/AMD1:2014 (edition 3.1) to this document
(edition 4.0) . 96
AA.2 Rationale for particular clauses and subclauses . 101
Annex BB (informative) Electronic imaging devices (e.g. epid) . 104
BB.1 General guidance . 104
BB.2 ELECTRONIC IMAGING DEVICES (e.g. EPID) (Clause 201.101 of
IEC 60601‑2‑1:2009) . 104
BB.2.1 Image coordinates and orientation (201.101.1 of IEC 60601-2-1:2009) . 104
BB.2.2 Image scale factor (201.101.2 of IEC 60601-2-1:2009) . 104
BB.2.3 Image field of view and alignment (201.101.3 of IEC 60601-2-1:2009) . 104
BB.2.4 EID PATIENT clearance (201.101.4 of IEC 60601-2-1:2009) . 104
BB.2.5 Artefacts (201.101.5 of IEC 60601-2-1:2009) . 104
Annex CC (informative) Latency and accuracy of dose delivery between CONTROL
................................................................................................................................. 106
POINTS
Annex DD (informative) Radiobiology considerations . 108
Bibliography . 109
Index of defined terms . 111
Figure 201.101 – Flattened area within the RADIATION FIELD . 19
Figure 201.102 – Limits of STRAY X-RADIATION during ELECTRON IRRADIATION . 59
Figure 201.103 – Limits of RELATIVE SURFACE DOSE during X-IRRADIATION . 61
Figure 201.104 – Elevation view – Application of LEAKAGE RADIATION requirements . 64
Figure 201.105 – 24 measurement points for averaging LEAKAGE RADIATION during X-
RADIATION . 67
– 4 – IEC 60601-2-1:2020 © IEC 2020
Figure 201.106 – Limits of LEAKAGE RADIATION through the BEAM LIMITING DEVICES during
ELECTRON IRRADIATION . 69
Figure 201.107 – Measurement points for averaging LEAKAGE RADIATION during
ELECTRON IRRADIATION . 71
Figure 201.108 – 24 measurement points for averaging LEAKAGE RADIATION
outside area M . 73
Figure 201.109 – ME EQUIPMENT movements and scales . 74
Figure AA.1 – Closed-loop control dose delivery system . 102
Figure AA.2 – Dynamic dose-positioning . 102
Figure CC.1 – Diagram to measure the BEAM GATING LATENCY at disabling IRRADIATION . 106
Figure CC.2 – Diagram to measure the BEAM GATING LATENCY at enabling IRRADIATION . 107
Figure CC.3 – BEAM HOLD and beam restart response times . 107
Table 201.101 – Dimensions defining the flattened area according to Figure 201.101 . 19
Table 201.102 – Data required in the technical description to support Clause 201.10
SITE TEST compliance . 26
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 . 28
Table 201.105 – Limits of RELATIVE SURFACE DOSE during X-IRRADIATION (see Figure
201.103) . 60
Table AA.1 – Items of consideration in the generation of this document . 96
Table AA.2 – Mapping of clauses in edition 3.1 to clauses in this document (excluding
Clause 201.10) . 97
Table AA.3 – New clauses in this document . 99
Table AA.4 – Mapping of clauses in edition 3.1 to clauses in this document
(Clause 201.10) . 100
IEC 60601-2-1:2020 © IEC 2020 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
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Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-1 has been prepared by subcommittee 62C: Equipment for
radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62:
Electrical equipment in medical practice.
This fourth edition 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.
– 6 – IEC 60601-2-1:2020 © IEC 2020
The text of this International Standard is based on the following documents:
FDIS Report on voting
62C/770/FDIS 62C/785/RVD
Full information on the voting for the approval of this document can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
• requirements and definitions: roman type;
• test specifications: italic type;
• informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
• TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
• "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
• "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb:
• "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
• "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
• "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
IEC 60601-2-1:2020 © IEC 2020 – 7 –
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of users of this document is drawn to the fact that equipment MANUFACTURERs and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.
– 8 – IEC 60601-2-1:2020 © IEC 2020
INTRODUCTION
The use of ELECTRON ACCELERATORS for RADIOTHERAPY purposes may expose PATIENTS to
danger if the ME EQUIPMENT fails to deliver the required dose distribution to the PATIENT, or if the
ME EQUIPMENT design fails to meet the requirements of BASIC SAFETY and ESSENTIAL
PERFORMANCE. The ME EQUIPMENT may also cause danger to persons in the vicinity if the
ME EQUIPMENT itself fails to contain the RADIATION adequately or if there are inadequacies in the
design of the TREATMENT ROOM.
This particular standard establishes requirements to be complied with by MANUFACTURERS in the
design and construction of ELECTRON ACCELERATORS for use in RADIOTHERAPY; it does not
attempt to define their optimum performance requirements. Its purpose is to identify those
features of design that are regarded, at the present time, as essential for the safe operation of
such ME EQUIPMENT. It places limits on the degradation of ME EQUIPMENT performance beyond
which it can be presumed that a fault condition exists and where an INTERLOCK then operates
to prevent continued operation of the ME EQUIPMENT.
Clauses 201.10, 201.103, 201.104, 201.105 and 201.108 contain limits beyond which
INTERLOCKS prevent, INTERRUPT or TERMINATE IRRADIATION in order to insure ESSENTIAL
PERFORMANCE is maintained to avoid an unsafe condition. In this document, the information in
Clause 201.10 has either been reorganized or moved to other clauses in order to better reflect
current usage and broaden the applicability of certain clauses to always apply to the
ME EQUIPMENT when IRRADIATION is being produced and not just when a PATIENT is being treated.
Annex AA provides a table showing the relationship between the clauses in IEC 60601-2-1:2009
and IEC 60601-2-1:2009/AMD1:2014 and the clauses in this document.
TYPE TESTS that are performed by the MANUFACTURER, or SITE TESTS, which are not necessarily
performed by the MANUFACTURER, are SPECIFIED for each requirement. It is understood that SITE
TESTS may or may not be required of the MANUFACTURER, per the agreement between the
MANUFACTURER and RESPONSIBLE ORGANIZATION.
Given that before installation a MANUFACTURER cannot provide SITE TEST data, data obtained
from SITE TESTS should be incorporated in the ACCOMPANYING DOCUMENTATION, in the form of a
SITE TEST report, by those who test the ME EQUIPMENT at installation.
IEC 60601-2-1 was first published in 1981. It was amended in 1984 and 1990. A second edition
was published in 1998 and amended in 2002. The third edition was prompted by the need to
align IEC 60601-2-1 with the third edition of the general standard, IEC 60601-1:2005, and was
amended in 2014. This fourth edition is prompted by the need to update IEC 60601-2-1 for the
technology that is in current use as well as to bring it into alignment with IEC 60601-1:2005 and
IEC 60601-2-1/AMD1:2012. This prompted the relabelling and organization of Clause 201.10
as well as the addition of Clauses 201.102 through 201.109.
IEC 60976:2007 and IEC TR 60977:2008 are closely related to the third edition of this
document. The former specifies test methods and reporting formats for performance tests of
ELECTRON ACCELERATORS for use in RADIOTHERAPY with the aim of providing uniform methods
for conducting such tests. The latter is not a performance standard but suggests performance
values, measured per the methods specified in IEC 60976, that could be achievable with
technology available at the time of publication. Until IEC 60976:2007 and IEC TR 60977:2008
are updated to match this document, it is suggested that MANUFACTURERs replace the word
"ISOCENTRE" with "EQUIPMENT REFERENCE POINT" when reading the test methods.
When a stated requirement does not apply to a given piece of equipment because the function
involved does not exist on that equipment, compliance with that requirement is not necessary.
However, when that stated requirement addresses a RISK that could be caused by a
substantially similar function of the equipment, the MANUFACTURER needs to address the RISK
caused by that similar function in the RISK MANAGEMENT FILE.
IEC 60601-2-1:2020 © IEC 2020 – 9 –
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
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
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.
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,
–1 –1
• maximum ABSORBED DOSE RATES between 0,001 Gy × s and 1 Gy × s 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.
___________
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.
– 10 – IEC 60601-2-1:2020 © IEC 2020
NOTE 2 In this particular standard, all references to installation refer to installation in the RESPONSIBLE
ORGANIZATION's premises.
NOTE 3 In this particular standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.
NOTE 4 The limits on maximum ABSORBED DOSE RATES are included for two reasons. The first is due to requirements
related to time in this document. This restriction limits the total dose that could be delivered during a SPECIFIED time
(examples: timer, TIME TO INTERRUPT or TERMINATE, LATENCY). The second is to limit the amount of RADIATION damage
that can occur during the time required to take action (often as a follow up to an INTERRUPTION or TERMINATION OF
IRRADIATION). Wherever requirements were made to limit the amount of dose delivered before action is taken, the
RADIATION damage was considered to be independent of the dose rate and only dependent on the dose. This would
largely hold true if the dose rate stayed within the range stated above.
IEC 61217 gives guidance on the designation of ME EQUIPMENT movements, the marking of
scales, their zero positions and the direction of movement with increasing value (see
201.7.4.101).
IEC 60976:2007 specifies methods of testing and disclosure of functional performance of
medical ELECTRON ACCELERATORS and is intended to facilitate comparisons of accelerator-based
ME EQUIPMENTs of different manufacture. IEC 60976:2007 contains no safety requirements, and
is not required to show compliance with this document. Until IEC 60976:2007 and
IEC TR 60977:2008 are updated to match this document, it is suggested that MANUFACTURERS
replace the word "ISOCENTRE" with "EQUIPMENT REFERENCE POINT" when reading the test
methods.
IEC TR 62926 provides guidance for integration of ELECTRON ACCELERATORS with other
equipment.
IEC TR 63183 provides guidance on the construction of error and warning messages.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ELECTRON ACCELERATORS in the range 1 MeV to 50 MeV and to
specify tests to check compliance to those requirements.
NOTE The adoption of this document helps to ensure that the ME EQUIPMENT
• maintains PATIENT safety during ME EQUIPMENT movements and failure of the SUPPLY MAINS,
• maintains OPERATOR and general public safety during ME EQUIPMENT NORMAL USE and failure of the SUPPLY MAINS,
• delivers the pre-selected RADIATION TYPE, NOMINAL ENERGY, and ABSORBED DOSE, and
• delivers the RADIATION in accordance with the pre-selected relationship of the RADIATION BEAM to the PATIENT,
without causing unnecessary RISK to the PATIENT, the OPERATOR, other persons or the environment.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014 applies. IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013 apply
as modified in Clause 206. IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013,
IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-9:2007 and
IEC 60601-1-9:2007/AMD1:2013, IEC 60601-1-10:2007 and IEC 60601-1-
10:2007/AMD1:2013, IEC 60601-1-11 and IEC 60601-1-12 do not apply, and all other collateral
standards in the IEC 60601-1 series do not apply.
IEC 60601-2-1:2020 © IEC 2020 – 11 –
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this
particular standard as the general standard. Collateral standards are referred to by their
document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of the
general standard with the prefix "201" (e.g. 201.1 in this document addresses the content of
Clause 1 of the general standard) or applicable collateral standard with the prefix "20x", where
x is the final digit(s) of the collateral standard document number (e.g. 202.4 addresses the
content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 addresses the content of
Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general
standard and applicable collateral standards are specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of the
general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.147, additional definitions in this document are numbered
beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items
aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, for example 202
for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general standard
or applicable collateral standard, although possibly relevant, is not to be applied, a statement
to that effect is given in this particular standard.
– 12 – IEC 60601-2-1:2020 © IEC 2020
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Req
...
The article discusses the EN IEC 60601-2-1:2021 standard, which applies to the basic safety and essential performance of electron accelerators used for treating patients. The standard includes type tests and site tests and applies to the manufacturing and installation of these accelerators. The accelerators are used for radiotherapy, delivering X-radiation or electron radiation with a nominal energy between 1 MeV and 50 MeV. They must be operated by qualified persons under the authority of a responsible organization and maintained according to the instructions for use. The standard replaces a previous edition and includes technical changes such as alignment with new collateral standards, the addition of computer interface and control, and the inclusion of new technologies in radiotherapy such as beam gating and adaptive radiotherapy.
기사 제목: EN IEC 60601-2-1:2021 - 의료용 전기 장비 - Part 2-1: 1 MeV에서 50 MeV까지의 범위 내 전자 가속기의 기본 안전 및 필수적인 성능에 대한 특정 요구 사항 기사 내용: IEC 60601-2-1: 2020은 1 MeV에서 50 MeV의 범위 내에서 환자 치료에 사용되는 전자 가속기의 기본 안전과 필수적인 성능에 적용됩니다. 노트 1에서는 환자 치료용으로 사용되는 전자 가속기는 항상 ME 장비로 취급되지만, 본 문서에서는 이들을 외부 광선 장비 (EBE)라고 칭합니다. EBE의 사용은 ME 장비에 부과된 요구 사항을 제거하지 않지만, ME 장비가 아닌 시스템 구성의 다른 ME 장비를 의미하는 것이 아니라 내용을 명확히 하기 위한 것입니다. 이 특정 표준은 유형 시험과 현장 시험을 포함하여 전자 가속기와 그에 포함된 장비의 제조 및 일부 설치 측면에 적용되며, 치료 정확도, 정확성 및 부피 목표를 향상시키기 위해 사용됩니다. 이는 의료 실습에서 방사선 치료를 위한 것으로, 선택된 치료 매개 변수의 선택 및 표시가 프로그램 가능한 전자 부분 시스템 (PESS)에 의해 자동으로 제어될 수 있습니다. 이러한 장비는 정상 상태 및 정상 사용에서 X-방사선 또는 전자 방사선의 방사 빔을 전송하며, 명시된 충족 조건에서 다음과 같은 특성을 가지고 있어야 합니다: • 1 MeV에서 50 MeV의 범위 내의 명시적 에너지, • 방사선 원천으로부터의 최대 흡수량의 가능한 용량 단위는 0.001 Gy x s -1에서 1 Gy x s -1, • 방사선 원천으로부터의 참조 치료 거리 (RTDs)는 0.5m에서 2m 사이, • 특정한 의료 응용 프로그램에 적합한 라이센스를 소지하거나 요구되는 기술을 가진 QUALIFIED PERSONS에 의해 책임 있는 조직의 권한으로 운영되며, • 별도의 사용 설명서에서 제시된 권고 사항에 따라 유지보수되며, QUALIFIED PERSON에 의해 정기적인 품질 보증 성능 및 보정 검사를 받아야 합니다. IEC 60601-2-1: 2020은 2009 년에 게시된 제 3 판과 개정 1:2014를 취소하고 대체합니다. 이번 판은 기존 판에 비해 중요한 기술적 변화인 다음과 같은 항목을 포함하고 있습니다: a) 새로운 관련 위반 표준과의 일치 b) 컴퓨터 인터페이스 및 제어의 추가 c) 빔 게이팅 및 적응 방사선 치료 등의 신기술을 포함합니다.
記事タイトル：EN IEC 60601-2-1:2021 - 医療電気機器 - Part 2-1: 電子加速器の基本的な安全性と必要な性能に関する特定の要件（1 MeVから50 MeVの範囲内） 記事内容：IEC 60601-2-1: 2020は、1 MeVから50 MeVの範囲内で使用される患者の治療における電子加速器の基本的な安全性と必要な性能に適用されます。注意１では、患者の治療に使用される電子加速器は常に医療用電気機器（ME EQUIPMENT）であるが、本文書では外部線源機器（EBE）として言及される場合があることを説明しています。EBEの使用はME EQUIPMENTに課せられる要件を除去するものではありませんが、ME EQUIPMENTとして議論されているのがEBEであり、システム構成の他のME EQUIPMENTとは異なることを明確にするためです。この特定の標準は、タイプテストと現地テストを含み、電子加速器およびそれに含まれる装置の製造および一部の設置の側面に適用されます。これらの加速器は放射線治療に使用され、1 MeVから50 MeVの範囲のX線または電子線を放射し、通常の条件で、通常の使用で、次の特性を持つ放射線ビームを提供することを意図しています。• 1 MeVから50 MeVの範囲の名目エネルギー、• 放射線源からの吸収される最大線量速度は0.001 Gy x s–1から1 Gy x s–1まで、• 放射線源からの参照治療距離（RTDs）は0.5 mから2 mまで、• 特定の医療応用に適した資格を持ち、特定の臨床目的のために責任ある組織の権限によって運営され、• 使用説明書に記載されている推奨事項に従って保守され、• 資格を持つ者による定期的な品質保証パフォーマンスおよび校正チェックを受けることが求められます。IEC 60601-2-1: 2020は、2009年に発行された第3版と改訂1:2014を取り消し、改訂版となります。本版には、次の主要な技術的変更が含まれています：a）新しい関連する関連規格との整合、b）コンピュータインタフェースと制御の追加、c）ビームゲーティング、およびアダプティブ放射線治療など、放射線治療の新技術の追加などです。
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