SIST EN 60601-2-1:2015

Medical electrical equipment -- Part 2-1: Particular requirements for basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

This standard 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. This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of ELECTRON ACCELERATORS - intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), - that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of XRADIATION and/or ELECTRON RADIATION having - NOMINAL ENERGY in the range 1 MeV to 50 MeV, - maximum ABSORBED DOSE RATES between 0,001 Gy × s-1 and 1 Gy × s-1 at 1 m from the RADIATION SOURCE, - NORMAL TREATMENT DISTANCES (NTDs) between 0,5 m and 2 m from the RADIATION SOURCE, and - intended to be - for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular specified clinical purposes, e.g. STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, - maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, - subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.

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: Règles particulières pour la sécurité de base et les performances essentielles des accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV

La CEI 60601-2-1:2009 s'applique à la sécurité de base et aux performances essentielles des accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV, et utilisés pour le traitement des patients. La présente norme particulière décrit les exigences auxquelles il convient que les fabricants se conforment dans la conception et la construction des accélérateurs d'électrons utilisés en radiothérapie; elle ne vise pas à définir des exigences de performances optimales. Son objet est d'identifier les caractéristiques de conception reconnues actuellement comme essentielles pour la sécurité de fonctionnement de tels appareils électromédicaux. Elle fixe des limites de détérioration des performances des appareils électromédicaux qui seraient la conséquence d'une condition de défaut, pour lesquelles un verrouillage doit entrer en action pour empêcher l'appareil em de continuer à fonctionner. Cette troisième édition annule et remplace la deuxième édition publiée en 1998 et son Amendement 1 (2002). Elle constitue une révision technique. Cette troisième édition aborde les questions suivantes non traitées dans les éditions antérieures:  - l'alignement avec les nouvelles normes collatérales pertinentes;  - les nouvelles technologies en radiothérapie, y compris la radiochirurgie stéréotaxique (SRT) et la radiothérapie stéréotaxique (SRS), la radiothérapie de conformation avec modulation d'intensité de dose (IMRT), les dispositifs d'imagerie numérique et la radiothérapie cinétique (thérapie dynamique).

Medicinska električna oprema - 2-1. del: Posebne zahteve za osnovno varnost in bistvene lastnosti elektronskih pospeševalnikov v območju od 1 MeV do 50 MeV

Ta standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ELEKTRONSKIH POSPEŠEVALNIKOV (v nadaljevanju »ELEKTROMEDICINSKA OPREMA«) v razponu od 1 MeV do 50 MeV za zdravljenje PACIENTOV. Ta standard z vključenimi TIPSKIMI PRESKUSI in PRESKUSI NA MESTU UPORABE se uporablja za proizvodnjo in določene vidike namestitve ELEKTRONSKIH POSPEŠEVALNIKOV (ki so namenjeni za RADIOTERAPIJO v okviru zdravljenja ljudi in pri katerih lahko PROGRAMLJIVI ELEKTRONSKI PODSISTEMI (PESS) samodejno nadzirajo izbiro in PRIKAZ parametrov delovanja), ki v OBIČAJNIH RAZMERAH in pri OBIČAJNI UPORABI oddajajo SEVALNE SNOPE RENTGENSKIH in/ali ELEKTRONSKIH ŽARKOV in vključujejo: – NOMINALNO ENERGIJO v razponu od 1 MeV do 50 MeV, – največje HITROSTI ABSORBIRANE DOZE od 0,001 Gy × s-1 do 1 Gy × s-1 na razdalji 1 m od VIRA SEVANJA, – OBIČAJNE RAZDALJE ZA ZDRAVLJENJE (NTD) od 0,5 m do 2 m od VIRA SEVANJA ter so predvideni za OBIČAJNO UPORABO, pri čemer jih morajo pod vodstvom ustrezno licenciranih ali KVALIFICIRANIH OSEB upravljati UPRAVLJAVCI z zahtevanimi veščinami za določeno medicinsko uporabo, za določene opredeljene klinične namene (npr. STACIONARNA RADIOTERAPIJA ali RADIOTERAPIJA S PREMIČNIM ŽARKOM), in morajo biti vzdrževani v skladu s priporočili, podanimi v NAVODILIH ZA UPORABO, ter predmet rednih pregledov zagotavljanja kakovosti, delovanja in umerjanja, ki jih opravi KVALIFICIRANA OSEBA.

General Information

• Status: Withdrawn
• Publication Date: 09-Nov-2015
• Withdrawal Date: 29-Jul-2024
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 30-Jul-2024
• Due Date: 22-Aug-2024
• Completion Date: 30-Jul-2024
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: 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

Relations

• Replaces: SIST EN 60601-2-1:2002 - Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV (IEC 60601-2-1:1998)
• Effective Date: 01-Dec-2015
• Replaces: SIST EN 60601-2-1:2002/A1:2003 - Medical electrical equipment -- Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV
• Effective Date: 01-Dec-2015
• Replaced By: 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)
• Effective Date: 20-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2015
1DGRPHãþD
SIST EN 60601-2-1:2002
SIST EN 60601-2-1:2002/A1:2003
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLHOHNWURQVNLKSRVSHãHYDOQLNRYYREPRþMXRG0H9GR0H9
Medical electrical equipment -- Part 2-1: Particular requirements for basic safety and
essential performance of electron accelerators in the range 1 MeV to 50 MeV
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: Règles particulières pour la sécurité de base et
les performances essentielles des accélérateurs d'électrons dans la gamme de 1 MeV à
50 MeV
Ta slovenski standard je istoveten z: EN 60601-2-1:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-1

NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2015
ICS 11.040.60 Supersedes EN 60601-2-1:1998
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 60601-2-1:2009 + A1:2014)
Appareils électromédicaux - Partie 2-1: Exigences Medizinische elektrische Geräte - Teil 2-1: Besondere
particulières de sécurité de base et de performances Festlegungen für die Sicherheit einschließlich der
essentielles pour les accélérateurs d'électrons dans la wesentlichen Leistungsmerkmale von
gamme de 1 MeV à 50 MeV Elektronenbeschleunigern
(IEC 60601-2-1:2009 + A1:2014) im Bereich von 1 MeV bis 50 MeV
(IEC 60601-2-1:2009 + A1:2014)
This European Standard was approved by CENELEC on 2015-09-15. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-1:2015 E
European foreword
The text of document 62C/474/FDIS, future edition 3 of IEC 60601-2-1, and the text of document
62C/532/CDV, future IEC 60601-2-1/A1, prepared by SC 62C "Equipment for radiotherapy, nuclear
medicine and radiation dosimetry", of IEC/TC 62 "Electrical equipment in medical practice" were
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-1:2015.
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2016-06-15
national level by publication of an identical national
standard or by endorsement
(dow) 2018-09-15
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-1:1998.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standards IEC 60601-2-1:2009 and IEC 60601-2-1:2009/A1:2014 were
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 60976:2007 NOTE Harmonized as EN 60976:2007 (not modified).
IEC 62366 NOTE Harmonized as EN 62366.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When 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.

Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Addition to Annex ZA of EN 60601-1:2006:
IEC/TR 60788 2004 Medical electrical equipment - Glossary - -
of defined terms
IEC 61217 1996 Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 60601-2-1 ®
Edition 3.1 2014-07
FINAL VERSION
VERSION FINALE
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 de sécurité de base et de performances
essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à
50 MeV
IEC 60601-2-1:2009-10+AMD1:2014-07 CSV(en-fr)

– 2 – IEC 60601-2-1:2009
+AMD1:2014 CSV  IEC 2014
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions. 11
201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 21
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 25
201.11 Protection against excessive temperatures and other HAZARDS . 47
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 47
201.13 HAZARDOUS SITUATIONS and fault conditions . 48
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 48
201.15 Construction of ME EQUIPMENT . 49
201.16 ME SYSTEMS . 49
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 49
206 Usability . 50
Annexes . 60
Annex B (informative) Sequence of testing . 60
Annex I (informative) ME SYSTEMS aspects . 60
Bibliography . 61
Index of defined terms . 62

Figure 201.101 – Limits of STRAY X-RADIATION during ELECTRON IRRADIATION
(201.10.1.2.102.1) . 52
Figure 201.102 – Limits of RELATIVE SURFACE DOSE during X-IRRADIATION

(201.10.1.2.102.2) . 53
Figure 201.103 – Elevation view – Application of LEAKAGE RADIATION requirements
(201.10.1.2.103 and 201.10.1.2.104) . 54
Figure 201.104 – 24 measurement points for averaging LEAKAGE RADIATION during X-
RADIATION (201.10.1.2.103.2.1) . 55
Figure 201.105 – Limits of LEAKAGE RADIATION through the BEAM LIMITING DEVICES during
ELECTRON IRRADIATION (201.10.1.2.103.2.2) . 56
Figure 201.106 – Measurement points for averaging LEAKAGE RADIATION during
ELECTRON IRRADIATION (201.10.1.2.103.2.2) . 57
Figure 201.107 – 24 measurement points for averaging LEAKAGE RADIATION outside
area M (201.10.1.2.103.3). 58
Figure 201.108 – ME EQUIPMENT movements and scales . 59

IEC 60601-2-1:2009 – 3 –
+AMD1:2014 CSV  IEC 2014
Table 201.101 – Colours of indicator lights and their meaning for ME EQUIPMENT . 16
Table 201.102 – Data required in the technical description to support Clause 201.10
SITE TEST compliance . 18
Table 201.103 – Clauses and subclauses in this particular standard that require the
provision of information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and
the technical description . 20
Table 201.104 – Limits of STRAY X-RADIATION during ELECTRON IRRADIATION (see
Figure 201.101) . 40
Table 201.105 – Limits of RELATIVE SURFACE DOSE during X-IRRADIATION (see
Figure 201.102) . 40

– 4 – IEC 60601-2-1:2009
+AMD1:2014 CSV  IEC 2014
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 p
...