IEC 60601-2-65:2012/AMD1:2017

Amendment 1 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

Specifies the requirements for testing items of equipment intended for use on railway vehicles which are subsequently subjected to vibrations and chock owing to the nature of railway operational environment.

Amendement 1 - Appareils électromédicaux - Partie 2-65: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires intra-oraux

Spécifie les prescriptions d'essai des matériels destinés à être utilisés sur les véhicules ferroviaires soumis à des vibrations et à des chocs dus à la nature de l'environnement d'exploitation ferroviaire.

General Information

• Status: Published
• Publication Date: 16-May-2017
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 45.060 - Railway rolling stock
• 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: 03-May-2017
• Completion Date: 17-May-2017

Relations

• Amends: IEC 60601-2-65:2012 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-65 ®
Edition 1.0 2017-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-65: Particular requirements for the basic safety and essential performance
of dental intra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X dentaires intra-oraux

IEC 60601-2-65:2012-09/AMD1:2017-05(en-fr)

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IEC 60601-2-65 ®
Edition 1.0 2017-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –

Part 2-65: Particular requirements for the basic safety and essential performance

of dental intra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à rayonnement X dentaires intra-oraux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-4260-5

– 2 – IEC 60601-2-65:2012/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:
CDV Report on voting
62B/1006/CDV 62B/1039/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 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 60601-2-65:2012 is to introduce changes to
reference the Amendment 1 (2012) to IEC 60601-1:2005. As neither IEC 60601-2-65:2012 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:
1)
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

© IEC 2017
201.1.3 Collateral standards
Replace the existing second sentence of the second paragraph by the following:
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 Terms and definitions
Replace, under "Amendment", "IEC 60601-1:2005" by "IEC 60601-1:2005 and IEC 60601-
1:2005/AMD1:2012".
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
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.

__________
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 60601-2-65:2012/AMD1:2017
© IEC 2017
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
MA
...