SIST EN IEC 60601-2-1:2021

SLOVENSKI STANDARD
SIST EN IEC 60601-2-1:2021
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
SIST EN IEC 60601-2-1:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN IEC 60601-2-1:2021

---------------------- Page: 2 ----------------------
SIST EN IEC 60601-2-1:2021


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

---------------------- Page: 3 ----------------------
SIST EN IEC 60601-2-1:2021
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)
2

---------------------- Page: 4 ----------------------
SIST EN IEC 60601-2-1:2021
EN IEC 60601-2-1:2021 (E)
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
3

---------------------- Page: 5 ----------------------
SIST EN IEC 60601-2-1:2021
EN IEC 60601-2-1:2021 (E)
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

4

---------------------- Page: 6 ----------------------
SIST EN IEC 60601-2-1:2021



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




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

---------------------- Page: 7 ----------------------
SIST EN IEC 60601-2-1:2021
– 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

---------------------- Page: 8 ----------------------
SIST EN IEC 60601-2-1:2021
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

---------------------- Page: 9 ----------------------
SIST EN IEC 60601-2-1:2021
– 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

---------------------- Page: 10 ----------------------
SIST EN IEC 60601-2-1:2021
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,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
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
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
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
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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.

---------------------- Page: 11 ----------------------
SIST EN IEC 60601-2-1:2021
– 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
...