iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
IEC

IEC 60336:2005

(Main)

Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots

Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots

Applies to focal spots in medical diagnostic X-ray tube assemblies or medical use, operating at X-ray tube voltages up to and including 200 kV. Describes the test methods for evaluating focal spot characteristics and the means for indicating compliance. The contents of the corrigendum of May 2006 have been included in this copy.

Appareils électromédicaux - Gaines équipées pour diagnostic médical - Caractéristiques des foyers

S'applique aux foyers des gaines équipées à usage médical, pour diagnostic médical, fonctionnant à des potentiels d'accélération de tubes radiogènes inférieurs ou égaux à 200 kV. Décrit les méthodes d'essai pour l'évaluation des caractéristiques des foyers et les moyens d'indiquer la conformité. Le contenu du corrigendum de mai 2006 a été pris en considération dans cet exemplaire.

General Information

Status
Published
Publication Date
19-Apr-2005
ICS
01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
11.040.50 - Radiographic equipment
Technical Committee
SC 62B - Medical imaging equipment, software, and systems
Drafting Committee
MT 32 - TC 62/SC 62B/MT 32
Current Stage
DELPUB - Deleted Publication
Start Date
19-Jan-2018
Completion Date
17-Dec-2020
Ref Project

Relations

Revised
IEC 60336:2020 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
Effective Date
05-Sep-2023

Buy Standard

IEC 60336:2005 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spotsIEC 60336:2005 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
PreviousNext
Standard
IEC 60336:2005 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
English and French language
77 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

NORME CEI
INTERNATIONALE
IEC



60336
INTERNATIONAL


Quatrième édition
STANDARD

Fourth edition
2005-04

Appareils électromédicaux –
Gaines équipées pour diagnostic médical –
Caractéristiques des foyers

Medical electrical equipment –
X-ray tube assemblies for medical diagnosis –
Characteristics of focal spots


Numéro de référence
Reference number
CEI/IEC 60336:2005

---------------------- Page: 1 ----------------------
Numérotation des publications Publication numbering
Depuis le 1er janvier 1997, les publications de la CEI As from 1 January 1997 all IEC publications are
sont numérotées à partir de 60000. Ainsi, la CEI 34-1 issued with a designation in the 60000 series. For
devient la CEI 60034-1. example, IEC 34-1 is now referred to as IEC 60034-1.
Editions consolidées Consolidated editions
Les versions consolidées de certaines publications de la The IEC is now publishing consolidated versions of its
CEI incorporant les amendements sont disponibles. Par publications. For example, edition numbers 1.0, 1.1
exemple, les numéros d’édition 1.0, 1.1 et 1.2 indiquent and 1.2 refer, respectively, to the base publication,
respectivement la publication de base, la publication de the base publication incorporating amendment 1 and
base incorporant l’amendement 1, et la publication de the base publication incorporating amendments 1
base incorporant les amendements 1 et 2. and 2.
Informations supplémentaires Further information on IEC publications
sur les publications de la CEI
Le contenu technique des publications de la CEI est The technical content of IEC publications is kept
constamment revu par la CEI afin qu'il reflète l'état under constant review by the IEC, thus ensuring that
actuel de la technique. Des renseignements relatifs à the content reflects current technology. Information
cette publication, y compris sa validité, sont dispo- relating to this publication, including its validity, is
nibles dans le Catalogue des publications de la CEI available in the IEC Catalogue of publications
(voir ci-dessous) en plus des nouvelles éditions, (see below) in addition to new editions, amendments
amendements et corrigenda. Des informations sur les and corrigenda. Information on the subjects under
sujets à l’étude et l’avancement des travaux entrepris consideration and work in progress undertaken by the
par le comité d’études qui a élaboré cette publication, technical committee which has prepared this
ainsi que la liste des publications parues, sont publication, as well as the list of publications issued,
également disponibles par l’intermédiaire de: is also available from the following:
• Site web de la CEI (www.iec.ch) • IEC Web Site (www.iec.ch)
• Catalogue des publications de la CEI • Catalogue of IEC publications
Le catalogue en ligne sur le site web de la CEI The on-line catalogue on the IEC web site
(www.iec.ch/searchpub) vous permet de faire des (www.iec.ch/searchpub) enables you to search by a
recherches en utilisant de nombreux critères, variety of criteria including text searches,
comprenant des recherches textuelles, par comité technical committees and date of publication. On-
d’études ou date de publication. Des informations en line information is also available on recently
ligne sont également disponibles sur les nouvelles issued publications, withdrawn and replaced
publications, les publications remplacées ou retirées, publications, as well as corrigenda.
ainsi que sur les corrigenda.
• IEC Just Published • IEC Just Published
Ce résumé des dernières publications parues This summary of recently issued publications
(www.iec.ch/online_news/justpub) est aussi dispo- (www.iec.ch/online_news/justpub) is also available
nible par courrier électronique. Veuillez prendre by email. Please contact the Customer Service
contact avec le Service client (voir ci-dessous) Centre (see below) for further information.
pour plus d’informations.
• Service clients • Customer Service Centre
Si vous avez des questions au sujet de cette If you have any questions regarding this
publication ou avez besoin de renseignements publication or need further assistance, please
supplémentaires, prenez contact avec le Service contact the Customer Service Centre:
clients:
Email: custserv@iec.ch Email: custserv@iec.ch
Tél: +41 22 919 02 11 Tel: +41 22 919 02 11
Fax: +41 22 919 03 00 Fax: +41 22 919 03 00
.

---------------------- Page: 2 ----------------------
NORME CEI
INTERNATIONALE
IEC



60336
INTERNATIONAL


Quatrième édition
STANDARD

Fourth edition

2005-04


Appareils électromédicaux –
Gaines équipées pour diagnostic médical –
Caractéristiques des foyers

Medical electrical equipment –
X-ray tube assemblies for medical diagnosis –
Characteristics of focal spots

 IEC 2005 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publicatio
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

IEC
IEC 61223-3-6:2020(Main)
Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation

IEC 61223-3-6:2020 applies to the performance of MAMMOGRAPHIC X-RAY EQUIPMENT when used in MAMMOGRAPHIC TOMOSYNTHESIS modes of operation, with respect to image quality and dose.
Excluded from the scope of this document are:
- MAMMOGRAPHIC X-RAY EQUIPMENT modes of operation other than MAMMOGRAPHIC TOMOSYNTHESIS;
- 2D images synthesised from the tomosynthesis images;
- reconstructive TOMOGRAPHY other than MAMMOGRAPHIC TOMOSYNTHESIS;
- CT SCANNERS covered by IEC 61223-3-5.
IEC 61223-3-6:2020 defines
a) the essential parameters which describe the acceptability criteria of MAMMOGRAPHIC TOMOSYNTHESIS modes of operation of MAMMOGRAPHIC X-RAY EQUIPMENT with regard to image quality and dose,
b) the methods of testing whether measured quantities related to those parameters comply with specified tolerances, and
c) CONSTANCY TEST frequency when required.
This document is intended to be applied along with the acceptability criteria included in IEC 61223-3-2 or equivalent protocol for 2D mammography which are also relevant for MAMMOGRAPHIC TOMOSYNTHESIS modes of operation.
These methods mainly rely on non-invasive measurements that use appropriate test equipment and are performed during or after the installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST. Tests required by a higher level of compliance take precedence over similar tests with a lower level of compliance.
When the results of the ACCEPTANCE TEST are in compliance with the expected values, the BASELINE VALUES for the subsequent CONSTANCY TESTS are established.

  • Standard
    108 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-43:2010/AMD2:2019(Amendment)
Amendment 2 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
  • Standard
    33 pages
    English and French language
    sale 15% off
IEC
IEC 61223-3-5:2019(Main)
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment

IEC 61223-3-5:2019 applies to CT SCANNERS that conform to IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD1:2012AMD2:2016.
IEC 60601-2-44 and this document
• defines the essential parameters which describe the performance of CT SCANNERS with regard to image quality, RADIATION OUTPUT and PATIENT positioning; the list of parameters to be tested can be found in section 4.3,
• defines the methods of testing the essential parameters, and
• evaluates compliance with the tolerances of the parameters SPECIFIED by the ACCOMPANYING DOCUMENTS.
The methods defined in IEC 60601-2-44 and this document rely on non-invasive measurements, using appropriate test equipment, performed during or after installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST report.
This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on a CT SCANNER. The aim of the ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The CONSTANCY TESTS are performed to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA and to enable the early recognition of changes in the properties of components of the EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning.
This document also contains requirements associated with ACCEPTANCE and CONSTANCY TESTING for the ACCOMPANYING DOCUMENTS of the CT SCANNER.
This document does not apply to
• aspects of mechanical and electrical safety, and
• aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and are directly affecting image quality, RADIATION OUTPUT and PATIENT positioning.
IEC 61223-3-5:2019 cancels and replaces the first edition published in 2004, and the second edition of IEC 61223-2-6 published in 2006. This edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous edition and to IEC 61223-2-6:
1) modification of the RADIATION protection and control;
2) modification of the acceptance testing;
3) introduction of constancy testing.
The contents of the corrigendum of June 2022 have been included in this copy.

  • Standard
    126 pages
    English and French language
    sale 15% off
IEC
IEC 62985:2019(Main)
Methods for calculating size specific dose estimates (SSDE) for computed tomography

IEC 62985:2019 applies to
– CT SCANNERS that are able to display and report CTDIVOL in accordance with
IEC 60601-2-44, and
– RADIATION dose index monitoring software (RDIMS)
for the purpose of calculating, displaying and recording the SIZE SPECIFIC DOSE ESTIMATE (SSDE) and its associated components.
Specifically, this document provides standardized methods and requirements for calculating, displaying, or recording of SSDE, SSDE(z), WATER EQUIVALENT DIAMETER (DW), and DW(z), where z represents a specific longitudinal position of the scanned object.
This document provides a method of determining a reference WATER EQUIVALENT DIAMETER, DW,REF(z), using CT scans of two cylindrical water PHANTOMS and one or more anthropomorphic PHANTOM(S), which conform to the specifications defined in this document. The method of calculating the WATER EQUIVALENT DIAMETER that is implemented by the MANUFACTURER, DW,IMP(z), is tested and validated against DW,REF(z) using the TEST OBJECTS and methods defined within this document. This document also describes the methods for calculating SSDE and DW, which represent the average values of SSDE(z) and DW(z) over the RECONSTRUCTION LENGTH.
The contents of the corrigendum of June 2022 have been included in this copy.

  • Standard
    42 pages
    English and French language
    sale 15% off
IEC
IEC 62464-1:2018(Main)
Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters

IEC 62464-1:2018 specifies measurement procedures for the determination of many essential image quality parameters for MR EQUIPMENT. Measurement procedures as addressed in this document are suitable for
– quality assessment in the ACCEPTANCE TEST, and
– quality assurance in the CONSTANCY TEST.
Required levels of performance for ACCEPTANCE TESTS are not provided for all tests.
This document does not address
– image quality assessment of MR EQUIPMENT with a static magnetic field intensity greater than 8 Tesla, if not otherwise stated,
– image quality affected by MR-compatibility issues,
– special diagnostic procedures such as flow imaging, perfusion, diffusion, radiotherapy and image-guided therapy applications, and
– TYPE TESTS.
The scope of this document is also limited to measuring image quality characteristics in images acquired on TEST DEVICES, not in PATIENT images.
The measurement procedures specified in this document are directed to
– MANUFACTURERS, who can demonstrate compliance by performing ACCEPTANCE and CONSTANCY TESTS as described by this document,
– test houses, who can confirm performance of MR EQUIPMENT using methods described in this document,
– regulatory authorities, who can reference this document, and
– RESPONSIBLE ORGANISATIONS who want to perform ACCEPTANCE and CONSTANCY TESTS using methods described in this document.
The essential image quality parameters and measurement methodologies defined in this document are
– SIGNAL TO NOISE RATIO,
– UNIFORMITY,
– SLICE THICKNESS in 2-D scanning,
– 2-D GEOMETRIC DISTORTION,
– SPATIAL RESOLUTION, and
– GHOSTING ARTEFACTS.
Each of these procedures can be performed standalone or in combination with any of the other procedures.
This document describes the preferred measurement procedures. It also describes alternative normative methods in Annex A. The preferred test methods may be substituted with these alternative normative methods. If necessary, other methods not described in this document can be used, provided those other test methods are documented and validated against the methods described in the document: it means an analysis is done by comparison to the original method that demonstrates a similar, or better, level of sensitivity to the same parameter of interest and a similar, or better, level of robustness against unrelated parameters. All methods will produce quantitative results.
The rationale to the preferred and alternate methods, and their pitfalls, are described in Annex B.
This document also presents requirements for CONSTANCY TESTS suitable for MR EQUIPMENT quality assurance programs concerning essential image quality parameters. There are no preferred CONSTANCY TEST methods, to provide flexibility in using existing automated procedures where available, but suggested examples of test methods can be found in Annex A. This document places an emphasis on consistently repeatable, automated measuring tools that facilitate trend analysis and the frequent quick testing of a small set of important parameters that are sensitive to the overall operating characteristics of the MR EQUIPMENT.
IEC 62464-1:2018 cancels and replaces the first edition published in 2007. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) the tests have been revised to comply with the technical progress;
b) the range of B0 was increased from 4 T to 8 T.

  • Standard
    178 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-54:2009/AMD2:2018(Amendment)
Amendment 2 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
  • Standard
    33 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-63:2012(Main)
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 applies to the basic safety and essential performance of dental extra-oral X-ray equipment, hereafter also called ME equipment. The scope includes ME systems containing such ME equipment. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental extra-oral x-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental extra-oral x-ray equipment. Components and their functions are addressed as far as necessary. The scope of this standard is restricted to X-ray equipment where:
- the x-ray tube assembly contains the high-voltage transformer assembly; and
- the geometrical relations between the X-ray source, the anatomical object being imaged in the patient, and the X-ray image receptor, are preset in the design and cannot be arbitrarily altered by the operator during intended use.

  • Standard
    95 pages
    English language
    sale 15% off
  • Standard
    92 pages
    English and French language
    sale 15% off
  • Standard
    193 pages
    English and French language
    sale 15% off
IEC
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
  • Standard
    9 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-43:2010/AMD1:2017(Amendment)
Amendment 1 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
  • Standard
    17 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-44:2009/AMD2:2016(Amendment)
Amendment 2 - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

Details the particular specification for light polyvinyl chloride sheathed cables of rated voltage of 300/500 V.[
]This consolidated version consists of the second edition (1992) and its amendment 1 (1997). Therefore, no need to order amendment in addition to this publication.

  • Standard
    8 pages
    English and French language
    sale 15% off