IEC 60601-2-63:2012/AMD1:2017
(Amendment)Amendment 1 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
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
- 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
- Effective Date
- 05-Sep-2023
Overview
IEC 60601-2-63:2012/AMD1:2017 is the first amendment to the international standard IEC 60601-2-63, which specifies the particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment. Published by the International Electrotechnical Commission (IEC), this amendment updates referenced standards and clarifies test and performance requirements, ensuring enhanced medical electrical equipment safety and reliability in dental radiology environments.
This amendment aligns IEC 60601-2-63 with the 2012 amendment to IEC 60601-1:2005, the general standard for medical electrical equipment. The update improves compliance clarity, removes superseded references, and refines test parameters related to electromagnetic compatibility, radiation protection, and equipment performance accuracy.
Key Topics
Scope Alignment: Incorporates references to IEC 60601-1:2005 and its Amendment 1 (2012) to maintain consistency across medical electrical equipment standards.
Collateral Standards Update: Clarifies that IEC 60601-1-8, IEC 60601-1-10, IEC 60601-1-11, and IEC 60601-1-12 are not applicable within this particular standard’s scope.
Normative References: Replaces outdated references, specifically updating IEC 60601-1-3 to include Amendment 1:2013 for radiation protection in diagnostic X-ray equipment, reflecting current best practices.
Terminology Revisions: Updates definitions to reference the amended IEC 60601-1:2005 standard, streamlining vocabulary such as essential performance, manufacturer, patient, risk, and single fault condition.
Electromagnetic Compatibility (EMC): Specifies that IEC 60601-1-2 applies with specific exceptions and allows manufacturers to minimize immunity testing of essential performance via risk management processes.
Radiation Protection Requirements: Enhances test descriptions and tolerance limits for key performance parameters including X-ray tube voltage, current, and irradiation time, establishing precision benchmarks with ±10% and ±20% accuracy where applicable.
Risk Management: Emphasizes the importance of the risk management process and maintenance of risk management files to verify compliance, reinforcing safety oversight.
Applications
Dental Radiology Equipment Manufacturers: Utilize this standard amendment to ensure dental extra-oral X-ray equipment meets international safety and performance benchmarks.
Medical Device Compliance and Testing Laboratories: Apply the updated EMC and radiation protection requirements during certification and quality assurance testing.
Healthcare Facilities and Dental Clinics: Benefit from improved safety standards incorporated into equipment, enhancing patient safety and diagnostic reliability.
Regulatory Bodies: Reference the amended standard when developing regulations and guidelines pertaining to dental X-ray equipment.
Risk Management Teams: Leverage the enhanced requirements to analyze and minimize potential hazards associated with medical electrical equipment operation.
Related Standards
IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 - General requirements for basic safety and essential performance of medical electrical equipment, foundational to all IEC 60601 series standards.
IEC 60601-1-2 - Collateral standard for electromagnetic disturbances requirements applicable with noted exceptions.
IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013 - Radiation protection collateral standard, specifying protection measures in diagnostic X-ray equipment.
IEC 60601-1-10, IEC 60601-1-11, IEC 60601-1-12 - Collateral standards for physiologic closed-loop controllers, home healthcare environments, and emergency medical services environments, respectively (not applicable per amendment).
IEC 60601-2-43 - Particular requirements for basic safety and essential performance of X-ray equipment, relevant for comparative understanding with general radiology equipment.
This amendment ensures that dental extra-oral X-ray equipment complies with evolving safety and performance requirements, integrating the latest medical electrical equipment standards. Adherence optimizes patient protection, equipment reliability, and regulatory compliance in the dynamic field of diagnostic dental imaging.
Frequently Asked Questions
IEC 60601-2-63:2012/AMD1:2017 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "Amendment 1 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment". This standard covers: Amendment 1 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
Amendment 1 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
IEC 60601-2-63:2012/AMD1:2017 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
IEC 60601-2-63:2012/AMD1:2017 has the following relationships with other standards: It is inter standard links to IEC 60601-2-63:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
IEC 60601-2-63:2012/AMD1:2017 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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 – Co
...
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