EN 61676:2002/A1:2009
(Amendment)Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
Medizinische elektrische Geräte - Geräte für die nicht-invasive Messung der Röntgenröhrenspannung in der diagnostischen Radiologie
Appareils électromédicaux - Instruments de dosimétrie pour la mesure non invasive de la tension du tube radiogène dans la radiologie de diagnostic
Medicinska električna oprema - Dozimetrijska oprema za posredno merjenje napetosti rentgenske elektronke v diagnostični radiologiji (IEC 61676:2002/A1:2008)
General Information
Relations
Overview
EN 61676:2002/A1:2009 is a European standard developed by CLC (European Committee for Electrotechnical Standardization) that specifies requirements for medical electrical equipment-specifically dosimetric instruments used for the non-invasive measurement of X-ray tube voltage in diagnostic radiology. This standard aligns with the International Electrotechnical Commission's IEC 61676:2002/A1:2008 publication and includes an amendment (A1) approved in 2009. It establishes guidelines and performance criteria to ensure accurate, reliable, and consistent measurements critical for diagnostic radiology applications.
Key Topics
- Non-invasive Dosimetry: Focus on instruments measuring X-ray tube voltage without direct contact or interference, promoting safety and operational efficiency.
- Measurement Ranges and Limits: Defines minimum rated range of use, intrinsic errors, and limits of variation to ensure precision in varying clinical settings.
- Influence Quantities: Addresses factors affecting measurement accuracy such as voltage waveform, anode angle, filtration, dose rate, irradiation time, field size, detector-focal distance, angle of incidence, rotation, temperature, humidity, power supply, and electromagnetic compatibility.
- Additional Tungsten Filtration: Introduces the concept of simulating tube aging's spectral changes by accounting for additional tungsten filtration (0 μm to 10 μm W), highlighting the importance of adapting measurements to the X-ray tube's wear status.
- Performance Testing: Details procedures to verify compliance with rated ranges and conditions, including new test methods addressing the effect of tube aging on measurement validity.
- Environmental and Operational Conditions: Sets reference and test conditions such as temperature (15 °C to 35 °C), relative humidity, and power supply variations to standardize measurement accuracy in clinical environments.
Applications
- Diagnostic Radiology Departments: EN 61676:2002/A1:2009 ensures that dosimetric instruments used in hospitals and clinics provide accurate X-ray tube voltage measurements, essential for patient safety and image quality.
- Quality Assurance Programs: Facilitates routine testing and calibration of radiology equipment by specifying performance and testing criteria, thus supporting regulatory compliance.
- Manufacturing of Dosimetric Instruments: Provides manufacturers clear criteria for design, testing, and certification of products intended for X-ray voltage measurement in diagnostic radiology.
- Radiation Safety Monitoring: Helps medical physicists and radiation safety officers monitor and control X-ray exposure to optimize diagnostic outcomes while minimizing unnecessary radiation doses.
- Maintenance and Equipment Lifecycle Management: The inclusion of tube aging effects through tungsten filtration simulation aids in planning maintenance schedules and replacement decisions for X-ray tubes.
Related Standards
- IEC 61676:2002 - The core international standard on which EN 61676 is based, covering dosimetric instruments for X-ray tube voltage measurement.
- IEC 61000 Series - Standards on electromagnetic compatibility, referenced in EN 61676 to ensure dosimetric instruments are resilient to electrical disturbances.
- Radiation Measurement Standards (ICS 17.240) - Provides a broader context on radiation measurement techniques applicable to diagnostic equipment.
- Diagnostic Radiology Equipment Standards (ICS 11.040.50) - Includes standards governing radiographic equipment performance in which EN 61676 instruments operate.
Keywords: EN 61676:2002/A1:2009, dosimetric instruments, X-ray tube voltage measurement, diagnostic radiology, non-invasive measurement, medical electrical equipment, radiation dosimetry, tungsten filtration, tube aging, IEC 61676, CENELEC standards, electromagnetic compatibility, quality assurance, diagnostic imaging equipment.
Frequently Asked Questions
EN 61676:2002/A1:2009 is a amendment published by CLC. Its full title is "Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology". This standard covers: Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
EN 61676:2002/A1:2009 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment; 11.040.55 - Diagnostic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 61676:2002/A1:2009 has the following relationships with other standards: It is inter standard links to EN IEC 61676:2023, EN 61676:2002. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 61676:2002/A1:2009 is associated with the following European legislation: EU Directives/Regulations: 2004/108/EC, 2004/108/EU, 2014/30/EU, 93/42/EEC; Standardization Mandates: M/432. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN 61676:2002/A1:2009 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CLC standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2009
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Medical electrical equipment - Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2002/A1:2008)
Medizinische elektrische Geräte - Geräte für die nicht-invasive Messung der
Röntgenröhrenspannung in der diagnostischen Radiologie (IEC 61676:2002/A1:2008)
Appareils électromédicaux - Instruments de dosimétrie pour la mesure non invasive de la
tension du tube radiogène dans la radiologie de diagnostic (IEC 61676:2002/A1:2008)
Ta slovenski standard je istoveten z: EN 61676:2002/A1:2009
ICS:
11.040.50 Radiografska oprema Radiographic equipment
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 61676/A1
NORME EUROPÉENNE
April 2009
EUROPÄISCHE NORM
ICS 11.040.50; 11.040.55
English version
Medical electrical equipment -
Dosimetric instruments used for non-invasive measurement
of X-ray tube voltage in diagnostic radiology
(IEC 61676:2002/A1:2008)
Appareils électromédicaux - Medizinische elektrische Geräte -
Instruments de dosimétrie Geräte für die nicht-invasive Messung
pour la mesure non invasive der Röntgenröhrenspannung
de la tension du tube radiogène in der diagnostischen Radiologie
dans la radiologie de diagnostic (IEC 61676:2002/A1:2008)
(CEI 61676:2002/A1:2008)
This amendment A1 modifies the European Standard EN 61676:2002; it was approved by CENELEC on
2009-03-01. 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 Central Secretariat 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
Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: avenue Marnix 17, B - 1000 Brussels
© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61676:2002/A1:2009 E
Foreword
The text of document 62C/445/CDV, future amendment 1 to IEC 61676:2002, prepared by SC 62C,
Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment
in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC
as amendment A1 to EN 61676:2002 on 2009-03-01.
The following dates were fixed:
– latest date by which the amendment has to be
implemented at national level by publication of
an identical national standard or by endorsement (dop) 2009-12-01
– latest date by which the national standards conflicting
with the amendment have to be withdrawn (dow) 2012-03-01
__________
Endorsement notice
The text of amendment 1:2008 to the International Standard IEC 61676:2002 was approved by
CENELEC as an amendment to the European Standard without any modification.
__________
IEC 61676
Edition 1.0 2008-11
INTERNATIONAL
STANDARD
AMENDMENT 1
Medical electrical equipment – Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
D
ICS 11.040.50; 11.040.55 ISBN 2-8318-1019-6
– 2 – 61676 Amend. 1 © IEC:2008
FOREWORD
This amendment has been prepared by subcommittee 62C, Equipment for radiotherapy,
nuclear medicine and radiation dosimetry, of IEC technical committee 62, Electrical equipment
in medical practice.
The text of this amendment is based on the following documents:
Enquiry draft Report on voting
62C/445/CDV 62C/452/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.
NOTE In this amendment, a new influence quantity “Additional tungsten filtration (tube aging)” has been
introduced.
The committee has
...
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