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IEC 60601-2-1:2009/AMD1:2014

(Amendment)

Amendment 1 - 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

Amendment 1 - 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

Amendement 1 - 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

General Information

Status
Published
Publication Date
20-Jul-2014
ICS
01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
11.040.60 - Therapy equipment
Technical Committee
SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
Drafting Committee
WG 1 - TC 62/SC 62C/WG 1
Current Stage
DELPUB - Deleted Publication
Completion Date
28-Oct-2020
Ref Project

Relations

Amends
IEC 60601-2-1:2009 - 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
05-Sep-2023
Revised
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
Effective Date
05-Sep-2023

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IEC 60601-2-1:2009/AMD1:2014 - Amendment 1 - 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 MeVIEC 60601-2-1:2009/AMD1:2014 - Amendment 1 - 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
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IEC 60601-2-1:2009/AMD1:2014 - Amendment 1 - 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
English and French language
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IEC 60601-2-1 ®
Edition 3.0 2014-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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(en-fr)

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IEC 60601-2-1 ®
Edition 3.0 2014-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX E
ICS 11.040.60 ISBN 978-2-8322-1748-1

– 2 – IEC 60601-2-1:2009/AMD1:2014
© IEC 2014
FOREWORD
This amendment has been prepared by subcommittee 62C: Equipment for radiotherapy,
nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment
in medical practice.
The text of this amendment is based on the following documents:
CDV Report on voting
62C/532/CDV 62C/562/RVC
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
_____________
3 Terms and definitions
201.3.227
TYPE TEST
Delete this entry.
201.5.4 Other conditions
Replace the existing text of this subclause with the following:
Item 5.4 a) of the general standard does not apply.
Replacement of item 5.4 d):
d) Where cooling water is required, water as required in the technical description is used.
Addition:
The manufacturer shall state in the ACCOMPANYING DOCUMENTS any additional requirement for
testing.
© IEC 2014
201.7.3.101 RADIATION HEAD
Replace the existing text of this subclause with the following:
Removal of the covers of the RADIATION HEAD shall expose safety sign 10 of Table D.2 of the
general standard, indicating “Follow instructions for use”.

201.8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
Replace the existing text of the addition by the following:
The requirements of 8.4.2 d) of the general standard do not apply where the installation
prevents the test rod or the test pin from being inserted into the openings concerned. The
ACCOMPANYING DOCUMENTS shall state when these conditions apply.

201.9.2.2.5 Continuous activation
Delete the addition.
201.9.2.101 GANTRY, RADIATION HEAD and PATIENT SUPPORT SYSTEM
Add under a) the following new item:
5) For the patient support system, these requirements shall apply when the system is
unloaded and when it is loaded with a distributed mass of 135 kg.
201.10.1.2.101.1.5 Selection of treatment parameters
Replace the existing title by the following:
201.10.1.2.101.1.5 VERIFICATION of data coherence and selection of treatment
parameters
Add the following new item:
c) Consistency, correctness and completeness of the data set imported shall be checked by
the ME EQUIPMENT before it can be accepted for IRRADIATION.
In the case of failure of the consistency, correctness or completeness of the data set being
loaded, IRRADIATION shall not be allowed to commence.
In the case of abnormal TERMINATION OF IRRADIATION the data set necessary to reconstruct
the treatment delivered shall be recorded. (See also 201.10.1.2.101.14).
In the case of restarting after abnormal TERMINATION OF IRRADIATION, the consistency,
correctness and completeness of the data set needed for continuation of IRRADIATION shall
ME EQUIPMENT before it can be accepted for IRRADIATION.
be checked by the
MANUF
...

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