Amendment 1 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Amendement 1 - Appareils électromédicaux - Partie 2-33: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à résonance magnétique utilisés pour le diagnostic médical

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Status
Published
Publication Date
22-Apr-2013
Current Stage
PPUB - Publication issued
Start Date
23-Apr-2013
Completion Date
23-Apr-2013
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IEC 60601-2-33:2010/AMD1:2013 - Amendment 1 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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IEC 60601-2-33
Edition 3.0 2013-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –

Part 2-33: Particular requirements for the basic safety and essential performance

of magnetic resonance equipment for medical diagnosis
Appareils électromédicaux –

Partie 2-33: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à résonance magnétique utilisés pour le diagnostic
médical
IEC 60601-2-33:2010/A1:2013
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 60601-2-33
Edition 3.0 2013-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –

Part 2-33: Particular requirements for the basic safety and essential performance

of magnetic resonance equipment for medical diagnosis
Appareils électromédicaux –

Partie 2-33: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à résonance magnétique utilisés pour le diagnostic
médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX G
ICS 11.040.55 ISBN 978-2-83220-751-2

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: 3 ----------------------
– 2 – 60601-2-33 Amend.1 © IEC:2013
FOREWORD

This amendment has been prepared by subcommittee 62B: Diagnostic imaging equipment, 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
62B/884/CDV 62B/904/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.
_____________
---------------------- Page: 4 ----------------------
60601-2-33 Amend.1 © IEC:2013 – 3 –
INTRODUCTION
This amendment has been published to adapt IEC 60601-2-33:2010 to the technical
corrections introduced by Amendment 1 (2012) to IEC 60601-1:2005.
201.1 Scope, object and related standards
In the footnote, replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
201.1.1 Scope
Replace the existing fourth paragraph with the following:

The standard does not formulate specific requirements for MR EQUIPMENT or MR SYSTEMS used

in INTERVENTIONAL MR EXAMINATIONS.
201.1.3 Collateral standards
Replace the second paragraph with the following:

IEC 60601-1-2:2007 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-10,

IEC 60601-1-11 and IEC 60601-1-12 do not apply. All other published collateral standards in

the IEC 60601-1 series apply as published.
201.2 Normative references
Replace the existing reference to IEC 60601-1:2005 by the following:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance
Amendment 1:2012
Replace the existing reference to NEMA MS 4:2006 by the following:

NEMA MS 4:2010, Acoustic noise measurement procedure for diagnostic magnetic resonance

imaging (MRI) devices
201.3 Terms and definitions
Replace the existing reference to IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
---------------------- Page: 5 ----------------------
– 4 – 60601-2-33 Amend.1 © IEC:2013
Table 201.101 – List of symbols
Delete the 14th row, containing the symbol t .
SAR
201.4.3 ESSENTIAL PERFORMANCE
Replace the existing Note 101 with the following:

NOTE 101 For the functions of the MR EQUIPMENT covered by this standard no specific ESSENTIAL PERFORMANCE

requirements have been identified. Other functions of the MR EQUIPMENT may constitute ESSENTIAL PERFORMANCE.

See the general standard for requirements to the RISK MANAGEMENT FILE of the MANUFACTURER to cover the analysis

of ESSENTIAL PERFORMANCE of the MR EQUIPMENT.
201.5.7 Humidity preconditioning treatment
Replace the existing paragraph by the following:

For those MR SYSTEMS and MR EQUIPMENT that are to be used only in controlled environments,

as to be specified in the technical description, no humidity preconditioning is required.

NOTE A controlled environment is not the same as CONTROLLED ACCESS AREA.
201.7 ME EQUIPMENT identification, marking and documents
Add the following subclause:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.13 Physiological effects (safety signs and warning statements)
Addition:

Applicable safety signs ISO 7010-W005 and ISO 7010-W006 shall be placed at the entrance

of the CONTROLLED ACCESS AREA. The safety signs may be accompanied by text explaining that

the magnetic field is always on, but that EMF emission is restricted to the situation when the

MR EQUIPMENT is scanning.

For MR EQUIPMENT that does not require a CONTROLLED ACCESS AREA, the need for and location

of the safety signs shall be described in the RISK MANAGEMENT FILE by the MANUFACTURER.

Information shall be provided in the instructions for use concerning specific physiological

effects related to MR EQUIPMENT.
201.7.9.2 Instructions for use
Add the following new subclause:
201.7.9.2.17 ME EQUIPMENT emitting radiation
Addition:

NOTE The instructions for use in 201.7.9.2.101 and the compatibility technical specification sheet in the technical

description in 201.7.9.3.101 provide detailed information concerning electromagnetic fields of the MR EQUIPMENT.

---------------------- Page: 6 ----------------------
60601-2-33 Amend.1 © IEC:2013 – 5 –
201.7.9.2.101 Instructions for use for MR EQUIPMENT
* d) Exposure of the PATIENT and MR WORKER to excessive acoustic noise
In the first dashed item of the second paragraph, replace NEMA MS 4:2005 by
NEMA MS 4:2010.
Replace the existing text of Note 1 with the following:
NOTE 1 An applicable safety sign is ISO 7010-M003 (2011).
* u) Scanning of pregnant PATIENTs
Add the following new text at the end of the subclause:

Attention shall be drawn to the fact that the fetus is considered as part of the general public,

and that it is especially sensitive to potential thermal events during the first trimester. The

RESPONSIBLE ORGANIZATION should be advised to avoid scanning patients in the first trimester

or with unknown pregnancy status.

NOTE Pregnancy status is part of the RIS information. It is recommended that feedback via the user interface be

provided to the OPERATOR during examination setup to validate the pregnancy status. The MR EQUIPMENT may

enforce scanning in NORMAL OPERATING MODE unless the pregnancy status is NO.
v) Scanning of PATIENTS with elevated body CORE TEMPERATURE.
Replace the existing text of the paragraph by the following:

The instructions for use shall describe that the MR EQUIPMENT provides the operating modes to

enable the OPERATOR to limit the body CORE TEMPERATURE rise of the PATIENT to avoid undue

heat stress an
...

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