SIST EN 60601-2-65:2013/A2:2021

Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (IEC 60601-2-65:2012/A2:2021)

No scope available

Medizinische elektrische Geräte - Teil 2-65: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von intraoralen zahnärztlichen Röntgeneinrichtungen (IEC 60601-2-65:2012/A2:2021)

Appareils élecromédicaux - 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/A2:2021)

Medicinska električna oprema - 2-65. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za intraoralni zobni rentgen - Dopolnilo A2 (IEC 60601-2-65:2012/A2:2021)

General Information

• Status: Published
• Publication Date: 21-Jul-2021
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.060.20 - Dental equipment
• ICS: 13.280 - Radiation protection
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Jul-2021
• Due Date: 05-Sep-2021
• Completion Date: 22-Jul-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 60601-2-65:2013/A2:2021 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

Overview

SIST EN 60601-2-65:2013/A2:2021 is a European standard that specifies particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment. Developed under the scope of medical electrical equipment standards and aligned with IEC 60601-2-65:2012/A2:2021, this amendment A2 brings critical updates focusing on radiation protection, operator safety, and quality control procedures. It targets manufacturers, healthcare providers, and regulatory bodies involved in the design, production, and use of intra-oral dental X-ray devices to ensure high safety standards and reliable performance in clinical settings.

Key Topics

• Basic Safety and Essential Performance
  The standard outlines strict parameters to ensure that dental intra-oral X-ray equipment is safe for both patients and operators while maintaining the device's essential medical imaging functions.

• Quality Control Procedures
  Manufacturers are required to provide device-specific quality control tools, such as phantoms or specialized software, enabling responsible organizations to perform routine safety and performance tests effectively.

• Radiation Protection and Operator Safety
  It emphasizes minimizing operator exposure to ionizing radiation, especially for hand-held equipment operators by:

  • Defining limits for leakage radiation with a maximum air kerma of 0.05 mGy per hour on the device’s surface under loading conditions.
  • Mandating protective shielding with a minimum of 0.25 mm lead equivalence to guard against stray radiation.
  • Including operator warnings about increased exposure risks due to proximity during hand-held device operation.

• Hand-Held Equipment Requirements
  Special provisions ensure hand-held X-ray source assemblies are equipped with safeguards such as:

  • Means to prevent unauthorized initiation (e.g., keys or passwords).
  • Support accessories that allow operation without continuous hand-holding, enabling the operator to maintain a safer distance during irradiation, often through a second activation switch.

• Patient Positioning and Irradiated Area Restriction
  Manufacturers must provide accessories to stabilize the intra-oral image receptor and precisely align the X-ray beam, thereby enhancing image quality and reducing unnecessary radiation exposure.

Applications

• Dental Clinics and Practitioner Use
  The standard directly applies to dental clinics using intra-oral X-ray devices, guaranteeing patient safety during diagnostic imaging and protecting dental practitioners from unsafe radiation exposure.

• Medical Device Manufacturing
  Manufacturers of dental X-ray systems use this standard to design and validate equipment that complies with EU regulations. It ensures devices meet essential performance benchmarks and conform to best practices for radiation safety.

• Regulatory Compliance and Certification
  Compliance with SIST EN 60601-2-65:2013/A2:2021 is often mandatory for market access within CENELEC member countries. Regulatory bodies rely on this standard for certification and auditing of dental X-ray equipment.

• Maintenance and Quality Assurance Programs
  Healthcare facilities implement quality control protocols as stipulated by the standard to maintain optimal equipment functionality and safety throughout the lifecycle of the X-ray units.

Related Standards

• EN 60601-1 – Medical electrical equipment – General requirements for basic safety and essential performance.
• IEC 60601-2-65 – International equivalent standard specifying dental intra-oral X-ray safety and performance requirements.
• EN 13737 – Dental radiographic equipment performance requirements.
• EN 62366 – Medical device usability engineering for safety and effectiveness.
• ISO 13485 – Quality management systems for medical devices – requirements for regulatory purposes.

These complementary standards provide a holistic framework supporting the development, deployment, and assurance of safe, effective medical electrical equipment, specifically targeting intra-oral dental X-ray systems.

---

Keywords: SIST EN 60601-2-65:2013/A2:2021, dental intra-oral X-ray equipment, medical electrical equipment, radiation protection, safety standards, intra-oral imaging, hand-held X-ray devices, operator safety, quality control procedures, CENELEC, IEC 60601-2-65.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2021
Medicinska električna oprema - 2-65. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za intraoralni zobni rentgen - Dopolnilo A2 (IEC 60601-2-
65:2012/A2:2021)
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and
essential performance of dental intra-oral X-ray equipment (IEC 60601-2-
65:2012/A2:2021)
Medizinische elektrische Geräte - Teil 2-65: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von intraoralen zahnärztlichen
Röntgeneinrichtungen (IEC 60601-2-65:2012/A2:2021)
Appareils élecromédicaux - 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/A2:2021)
Ta slovenski standard je istoveten z: EN 60601-2-65:2013/A2:2021
ICS:
11.060.20 Zobotehnična oprema Dental equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-65:2013/A2

NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2021
ICS 11.040.50
English Version
Medical electrical equipment - Part 2-65: Particular requirements
for the basic safety and essential performance of dental intra-
oral X-ray equipment
(IEC 60601-2-65:2012/A2:2021)
Appareils élecromédicaux - Partie 2-65: Exigences Medizinische elektrische Geräte - Teil 2-65: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils à rayonnement X dentaires intra- wesentlichen Leistungsmerkmale von intraoralen
oraux zahnärztlichen Röntgeneinrichtungen
(IEC 60601-2-65:2012/A2:2021) (IEC 60601-2-65:2012/A2:2021)
This amendment A2 modifies the European Standard EN 60601-2-65:2013; it was approved by CENELEC on 2021-06-07. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the
status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-65:2013/A2:2021 E

European foreword
The text of document 62B/1233/FDIS, future IEC 60601-2-65/A2, prepared by SC 62B "Diagnostic
imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-
CENELEC parallel vote and approved by CENELEC as EN 60601-2-65:2013/A2:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-03-07
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-06-07
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 60601-2-65:2012/A2:2021 was approved by CENELEC as
a European Standard without any modification.

IEC 60601-2-65 ®
Edition 1.0 2021-05
INTERNATIONAL
STANDARD
AMENDMENT 2
Medical electrical equipment –

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

performance of dental intra-oral X-ray equipment

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-9630-1

– 2 – IEC 60601-2-65:2012/AMD2:2021
© IEC 2021
FOREWORD
This second 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/1233/FDIS 62B/1238/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 unchan
...