IEC 60601-2-1:1998/AMD1:2002

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

General Information

• Status: Published
• Publication Date: 07-May-2002
• ICS: 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: 14-Oct-2009

Relations

• Amends: IEC 60601-2-1:1998 - Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
• Effective Date: 05-Sep-2023
• Revised: 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

Standards Content (Sample)

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
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– 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• withdrawn;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 limit the leakage to an average of 0,75 %.

60601-2-1 Amend. 1  IEC:2002(E) – 3 –

Page 87
29.3.1.1 X-radiation
Replace the existing text of this subclause by the following:

Measurements of LEAKAGE RADIATION through all combinations of BLDs shall be made with any

residual aperture shielded by at least two TENTH-VALUE LAYERS OF X-RADIATION absorbing

7)
material . For non-overlapping BLDs, measurements shall be made at minimum RADIATION

FIELD size.
Adjustable or interchangeable BLDs shall be provided. Where any set or combinations of
BLDs (including any multi-element BLDs) can overlap, these requirements shall apply to each
independent set or combination measured together at the same time:
a) each BLD (excluding those multi-element BLDs for which c) applies) shall attenuate X-
RADIATION such that anywhere in the area M, excepting the residual rectangular RADIATION
FIELD, the ABSORBED DOSE due to leakage RADIATION does not exceed 2 % of the maximum
ABSORBED DOSE measured on the REFERENCE AXIS at NTD in a 10 cm × 10 cm RADIATION
FIELD;
b) for RADIATION FIELDS of any size, the average ABSORBED DOSE D , due to LEAKAGE
LX
RADIATION through the BLDs, including multi-element BLDs, in the area M, shall not
exceed 0,75 % of the maximum ABSORBED DOSE on the REFERENCE AXIS at NTD in a
10 cm × 10 cm RADIATION FIELD. If this limit is exceeded when areas of greater than
300 cm at NTD are protected by multi-element BLDs, the conditions under which the limit
is exceeded and the extent to which the limit is ex
...