EN 60601-2-1:1998/A1:2002

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

EN following parallel vote

Medizinische elektrische Geräte - Teil 2-1: Besondere Festlegungen für die Sicherheit von Elektronenbeschleunigern im Bereich von 1 MeV bis 50 MeV

Appareils électromédicaux - Partie 2-1: Règles particulières de sécurité pour les accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV

Medicinska električna oprema - 2. del: Posebne varnostne zahteve za elektronske pospeševalnike v območju od 1 MeV do 50 MeV - Dopolnilo A1 (IEC 60601-2-1:1998/A1:2002)

General Information

• Status: Withdrawn
• Publication Date: 06-Jun-2002
• Withdrawal Date: 31-May-2005
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Parallel Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Sep-2018
• Completion Date: 15-Sep-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: 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

Relations

• Replaced By: 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: 28-Jan-2023
• Amends: EN 60601-2-1:1998 - 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: 29-Jan-2023

Standards Content (Sample)

EUROPEAN STANDARD EN 60601-2-1/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM June 2002
ICS 11.040.60
English version
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/A1:2002)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-1: Règles particulières Teil 2-1: Besondere Festlegungen für die
de sécurité pour les accélérateurs Sicherheit von Elektronenbeschleunigern
d'électrons dans la gamme im Bereich von 1 MeV bis 50 MeV
de 1 MeV à 50 MeV (IEC 60601-2-1:1998/A1:2002)
(CEI 60601-2-1:1998/A1:2002)
This amendment A1 modifies the European Standard EN 60601-2-1:1998; it was approved by CENELEC
on 2002-06-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this amendment 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 Central Secretariat or to any CENELEC member.
This amendment 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
Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands,
Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2002 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-1:1998/A1:2002 E

Foreword
The text of document 62C/329/FDIS, future amendment 1 to IEC 60601-2-1:1998, 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 was
approved by CENELEC as amendment A1 to EN 60601-2-1:1998 on 2002-06-01.
The following dates were fixed:
– latest date by which the amendment has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2003-03-01
– latest date by which the national standards conflicting
with the amendment have to be withdrawn (dow) 2005-06-01
__________
Endorsement notice
The text of amendment 1:2002 to the International Standard IEC 60601-2-1:1998 was approved by
CENELEC as an amendment to the European Standard without any modification.
__________
INTERNATIONAL IEC
STANDARD
60601-2-1
AMENDMENT 1
2002-05
Amendment 1
Medical electrical equipment –
Part 2-1:
Particular requirements for the safety
of electron accelerators in the range
1 MeV to 50 MeV
Amendement 1
Appareils électromédicaux –
Partie 2-1:
Règles particulières de sécurité pour les accélérateurs
d’électrons dans la gamme de 1 MeV à 50 MeV
 IEC 2002 Droits de reproduction réservés  Copyright - all rights reserved
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail]  Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale
D
International Electrotechnical Commission
Международная Электротехническая Комиссия
For price, see current catalogue

– 2 – 60601-2-1 Amend. 1  IEC:2002(E)
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:
FDIS Report on voting
62C/329/FDIS 62C/334/RVD
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 the base publication and its amendment will
remain unchanged until 2005. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
_____________
INTRODUCTION
Subclause 29.3.1.1 of IEC 60601-2-1:1998 sets limits to X-ray leakage radiation through
beam limiting devices (BLDs) in the patient plane in order to reduce the detrimental effects on
the patient due to leakage radiation. This clause restricts leakage through the main X and Y
BLDs to a maximum of 2 % and an average of 0,5 %. Multi-element BLDs were assumed to
replace a beam shielding block which attenuated the beam to about 5 %, and this was the
upper limit applied to multi-element BLDs.
With the growth of techniques such as conformal therapy and IMRT, multi-element BLDs
(which allow higher leakage levels) are being used to shield more of the radiation field area
than was the case with conventional techniques using beam blocks. It is now proposed in the
replacement subclause 29.3.1.1 to set a leakage tolerance on the total beam limiting system
(the X and Y BLDs themselves may be single element, multi-element, or a combination of
both) and to
...