EN IEC 60601-2-1:2021

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

• Status: Published
• Publication Date: 15-Jul-2021
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 16-Jul-2021
• Completion Date: 16-Jul-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN IEC 60601-2-1:2021 - 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)

Relations

• Replaces: EN 60601-2-1:2015 - 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
• Effective Date: 07-Jun-2022

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
...