IEC 60601-2-63:2012/AMD1:2017

Amendment 1 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

Amendement 1 - Appareils électromédicaux - Partie 2-63: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires extra-oraux

General Information

• Status: Published
• Publication Date: 06-Jul-2017
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 39 - TC 62/SC 62B/WG 39
• Current Stage: PPUB - Publication issued
• Start Date: 07-Jul-2017
• Completion Date: 07-Jul-2017

Relations

• Amends: IEC 60601-2-63:2012 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-63 ®
Edition 1.0 2017-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-63: Particular requirements for the basic safety and essential performance
of dental extra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-63: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X dentaires extra-oraux

IEC 60601-2-63:2012-09/AMD1:2017-07(en-fr)

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IEC 60601-2-63 ®
Edition 1.0 2017-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –

Part 2-63: Particular requirements for the basic safety and essential performance

of dental extra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-63: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à rayonnement X dentaires extra-oraux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-4454-8

– 2 – IEC 60601-2-63:2012/AMD1:2017
© IEC 2017
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:
FDIS Report on voting
62B/1049/FDIS 62B/1058/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 this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website 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.
_____________
INTRODUCTION TO AMENDMENT 1
The purpose of this first amendment to IEC 60601-2-63:2012 is to introduce changes to
reference the Amendment 1 (2012) to IEC 60601-1:2005. As neither IEC 60601-2-63:2012 nor
this amendment refers to specific elements of IEC 60601-1-2, the introduction of a dated
reference to the latter document has been removed.
_____________
201.1 Scope, object and related standards
Replace the text of the existing footnote by the following:

The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
201.1.3 Collateral standards
Replace the existing second sentence of the second paragraph by the following:

© IEC 2017
1 2 3
IEC 60601-1-8, IEC 60601-1-10 , IEC 60601-1-11 and IEC 60601-1-12 do not apply
201.2 Normative references
Delete, under "Replacement", the existing reference to IEC 60601-1-2:2007.
Replace, under "Replacement", the existing reference to IEC 60601-1-3 by the following:
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral Standard: Radiation protection in diagnostic
X-ray equipment
IEC 60601-1-3:2008/AMD1:2013
Add, under "Addition", the following new reference:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
201.3 Terminology and definitions
Replace, under "Amendment", "IEC 60601-1:2005" by "IEC 60601-1:2005 and IEC 60601-
1:2005/AMD1:2012".
ESSENTIAL PERFORMANCE requirements
201.4.3.101 Additional
Replace the existing title of this subclause by the following:
201.4.3.101 Additional potential ESSENTIAL PERFORMANCE requirements
202 Electromagnetic compatibility – Requirements and tests
Replace the first sentence of this subclause by the following:
IEC 60601-1-2 applies, except as follows.
202.101 Immunity testing of ESSENTIAL PERFORMANCE
Replace the existing first paragraph by the following new paragraph:
The MANUFACTURER may minimize the test requirements of the additional potential ESSENTIAL
PERFORMANCE requirements listed in Table 201.101 to a practical level through the RISK
MANAGEMENT PROCESS.
Replace the last paragraph by the following new paragraphs:
ME EQUIPMENT being tested shall not be modified to perform this immunity test.
Compliance is checked by the inspection of RISK MANAGEMENT FILE.
203 Radiation protection in diagnostic X-ray equipment
Replace, in the first sentence, "IEC 60601-1-3:2008 applies" by "IEC 60601-1-3:2008 and
IEC 60601-1-3:2008/AMD1:2013 apply".
___________
IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers
IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment
IEC 60601-1-12, Medical electrical equipment – Part 1-12: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment

– 4 – IEC 60601-2-63:2012/AMD1:2017
© IEC 2017
203.6.4.3.102.2 *Accuracy of X-RAY TUBE VOLTAGE
Replace, in the first sentence, "10 %" by "± 10 %".
203.6.4.3.102.3 Accuracy of X-RAY TUBE CURRENT
Replace, in the first sentence, "20 %" by "± 20 %".
203.6.4.3.102.4 *Accuracy of IRRADIATION TIME
Replace, in the first sentence, "(5 % + 50 ms)" by "± (5 % + 50 ms)".

Bibliography
Replace, in reference [34], “IEC 60601-2-43:2010” by "IEC 60601-2-43”.
Add, at the end of the existing list, the following new references:
[38] IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for the
development of physiologic closed-loop controllers
[39] IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare
environment
[40] IEC 60601-1-12, Medical electrical equipment – Part 1-12: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems intended for use in the emergency
medical services environment
© IEC 2017
Index of defined terms used in this particular standard
Replace, in the note, "IEC 60601-1:2005" by "IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012".
Replace the references to the following terms:
ESSENTIAL PERFORMANCE IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.27
HAND-HELD IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.37
HAZARD IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.39
INTENDED USE IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.44
MAINS PART IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.49
MANUFACTURER IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.55
MOBILE IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.65
NORMAL USE IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.71
PATIENT IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.76
PROCEDURE IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.88
PROCESS IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.89
RISK IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.102
RISK MANAGEMENT IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.107
RISK MANAGEMENT FILE IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.108
SINGLE FAULT CONDITION IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.116
TRANSPORTABLE IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.130

Add the following new reference to the existing list:
EARTH LEAKAGE CURRENT IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.25

___________
– 6 – IEC 60601-2-63:2012/AMD1:2017
© IEC 2017
AVANT-PROPOS
Le présent amendement a été établi par le sous-comité 62B: Appareils d'imagerie de
diagnostic, du comité d'études 62 de l'IEC: Équipements électriques dans la pratique
médicale.
Le texte de cet amendement est issu des documents suivants:
FDIS Rapport de vote
62B/1049/FDIS 62B/1058/RVD
Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant
abouti à l'approbation de cet amendement.
...