IEC 60601-2-33:2010/AMD1:2013
(Amendment)Amendment 1 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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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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
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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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX G
ICS 11.040.55 ISBN 978-2-83220-751-2
– 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.
_____________
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.
– 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.
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 and prevent local tissue damage in the body of the PATIENT. Applicable limit values
can be found in Table 201.104.
201.7.9.3 Technical description
Add the following subclause:
201.7.9.3.1 General
Replacement of the eighth dashed item of the first paragraph and Note 2:
– information pertaining to any necessary recurrent BASIC SAFETY testing including details of
the means, methods and recommended frequency.
201.7.9.3.101 Technical description of MR EQUIPMENT
b) Compatibility technical specification sheet
Replace, in the second bullet point of the second dashed item, the value 0,02 m by 0,05 m
– 6 – 60601-2-33 Amend.1 © IEC:2013
* 201.8.7.3 Allowable values
Reletter additional item e) as item aa).
201.9.8.3.3 Dynamic forces due to loading from persons
Delete this subclause.
201.12 Accuracy of controls and instruments and protection against hazardous
outputs
201.12.4 Protection against hazardous output
Add the following new subclauses:
201.12.4.1 Intentional exceeding of safety limits
Addition:
NOTE The second level controlled operating mode covers all relevant requirements for MR EQUIPMENT.
201.12.4.2 Indication relevant to safety
Addition:
NOTE All relevant requirements for MR EQUIPMENT are covered in 201.12.4.101
Annex AA – Particular guidance and rational
AA.1 Rationale for particular clauses and subclauses
Add the following rationale:
Concerning 201.9.8.3.3 – Dynamic forces due to loading from persons (deleted)
Subclause 201.9.8.3.3 was introduced in the third edition of this standard. However the
rational for this subclause in IEC 60601-1:2005 states that the requirement regarding the
dynamic load test is only applicable for chairs and tables where dynamic load can be
expected such as chairs for dental surgical procedures, X-ray tables, and many other similar
types of ME EQUIPMENT. For patient tables used with MR or CT, it is not applicable, as the
dynamic loading caused by a PATIENT is negligible.
Bibliography
Replace existing reference [166] with the following:
[166] ISO 7010:2011, Graphical symbols – Safety colors and safety signs – Registered
safety signs
_____________
– 8 – 60601-2-33 Amend.1 © CEI:2013
AVANT-PROPOS
Le présent amendement a été établi par le sous-comité 62B: Appareils d'imagerie de
diagnostic, du comité d'études 62 de la CEI: Équipements électriques dans la pratique
médicale.
Le texte de cet amendement est issu des documents suivants:
CDV Rapport de vote
62B/884/CDV 62B/904/RVC
Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant
abouti à l'approbation de cet amendement.
Le comité a décidé que le contenu de cet amendement et de la publication de base ne sera
pas modifié avant la date de stabilité indiquée sur le site web de la CEI sous
"http://webstore.iec.ch" dans le
...
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