iTeh Standards logo
EURUSD
Your shopping cart is empty.
IEC

IEC 60336:2020/COR1:2022

(Corrigendum)

Corrigendum 1 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics

Corrigendum 1 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics

Corrigendum 1 - Appareils électromédicaux - Gaines équipées pour diagnostic médical - Dimensions des foyers et caractéristiques connexes

General Information

Status
Published
Publication Date
20-Jun-2022
ICS
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
PPUB - Publication issued
Start Date
21-Jun-2022
Completion Date
12-Aug-2022
Ref Project

Relations

Corrects
IEC 60336:2020 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
Effective Date
05-Sep-2023
IEC 60336:2020/COR1:2022 - Corrigendum 1 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics Released:6/21/2022IEC 60336:2020/COR1:2022 - Corrigendum 1 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics Released:6/21/2022
PreviousNext
Standard
IEC 60336:2020/COR1:2022 - Corrigendum 1 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics Released:6/21/2022
English and French language
2 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)


 IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
____________
IEC 60336 IEC 60336
Edition 5.0  2020-12 Édition 5.0  2020-12

Medical electrical equipment – X-ray tube Appareils électromédicaux – Gaines équipées
assemblies for medical diagnosis – pour diagnostic médical –
Focal spot dimensions and related Dimensions des foyers et caractéristiques
characteristics connexes
CO RRI G E NDUM 1
E.6.2 Fifth edition technical details E.6.2 Informations techniques
concernant la cinquième édition
Add, after the second paragraph of item
b) in bold, the following new item c): Ajouter, après le second alinéa de
l'élément b) en gras, le nouvel élément c)
LIT CAMERA and PINHOLE CAMERA
c) S
suivant:
As in the fourth edition, FOCAL SPOT SLIT
c) CAMERA A FENTE et CAMERA A STENOPE
are used to determine THE
RADIOGRAMS
NOMINAL FOCAL SPOT VALUES, and a FOCAL Tout comme dans la quatrième édition,
SPOT PINHOLE RADIOGRAM is used for les RADIOGRAMMES A FENTE sont utilisés
information about the intensity pour déterminer les VALEURS NOMINALES
distribution of the FOCAL SPOT. DU FOYER et un RADIOGRAMME A STENOPE
est utilisé pour s’informer de la répartition
FOYER.
d’intensité d’un
IEC 60336:2020-12/COR1:2022-06(en-fr)

– 2 – IEC 60336:2020/COR1:2022
 IEC 2022
As it is mathematically straight forward to Étant donné qu’il est facile de calculer
calculate exactly FOCAL SPOT SLIT mathématiquement et de manière exacte
RADIOGRAMS from a FOCAL SPOT PINHOLE les RADIOGRAMMES
...

Questions, Comments and Discussion

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

Loading comments...

This May Also Interest You

IEC
IEC 62570:2025(Main)
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
This document specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.
MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination.

  • Standard
    18 pages
    English language
    sale 15% off
  • Standard
    27 pages
    French language
    sale 15% off
  • Standard
    45 pages
    English and French language
    sale 15% off
IEC
IEC 61223-3-8:2024(Main)
Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy

IEC 61223-3-8:2024 applies to evaluation of the imaging performance and related quality control parameters of X‑ray equipment for radiography and radioscopy that conform to IEC 60601-2-54:2022 or IEC 60601-2-43:2022.
This document applies to the evaluation of the imaging performance of the entire imaging chain from image acquisition, image processing and image display.
This document applies to acceptance tests and constancy tests, which are part of the quality assurance program in medical imaging departments and are intended to be performed by or under the responsibility of the responsible organization. A detailed discussion of the position of these tests within the medical radiological equipment lifecycle is provided in Clause A.2. The methods included rely mainly on non-invasive measurements that use appropriate test equipment and are performed after the installation is completed in accordance with the manufacturer’s installation instructions.
IEC 60601-2-54:2022 and IEC 60601-2-43:2022 require information to be provided to the responsible organization with respect to quality control. This document provides guidance to manufacturers regarding the acceptance and constancy tests for the X‑ray equipment in a manufacturer supplied quality control manual. Annex G provides guidance for such a manual.

  • Standard
    199 pages
    English and French language
    sale 15% off
IEC
IEC 62220-2-1:2023(Main)
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 2-1: Determination of dual-energy subtraction efficiency - Detectors used for dual-energy radiographic imaging

IEC 62220-2-1:2023 describes the performance metrics associated with DUAL-ENERGY IMAGING capable DIGITAL X-RAY IMAGING DEVICES meant for medical applications and specifies the methods for their determination. These metrics can be used to analyse TISSUE-SUBTRACTED IMAGES and to evaluate dose performance, noise characteristics, and tissue-subtraction efficacy of DIGITAL X-RAY IMAGING DEVICES. The described methods indicate the procedures to obtain MULTI-SPECTRAL PRIMARY DATA and to compute their derived TISSUE-SUBTRACTED IMAGES.
The intended users of this document are MANUFACTURERS and well-equipped test laboratories. This document is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for single or multiple exposure dual-energy radiographic imaging based on, for example, CR systems, direct and indirect flat panel-detector based systems.
This document excludes and is not applicable to:
– DIGITAL X-RAY IMAGING DEVICES intended to be used in mammography or in dental RADIOGRAPHY;
– slot scanning DIGITAL X-RAY IMAGING DEVICES;
– COMPUTED TOMOGRAPHY or CONE-BEAM COMPUTED TOMOGRAPHY;
– photon-energy discriminating devices such as photon counting X-RAY IMAGING DEVICES;
– devices for dynamic imaging (where series of images are acquired, as in fluoroscopy or cardiac imaging).
– DIGITAL X-RAY IMAGING DEVICES intended to be used with RADIOTHERAPY beams.

  • Standard
    43 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-43:2022(Main)
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

IEC 60601-2-43:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular:
- equipment for RADIOTHERAPY;
- equipment for COMPUTED TOMOGRAPHY;
- ACCESSORIES intended to be introduced into the PATIENT;
- mammographic X RAY EQUIPMENT;
- dental X RAY EQUIPMENT.
INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this document.
If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant.
IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.
IEC 60601-2-43:2022 cancels and replaces the second edition published in 2010, Amendment 1:2017 and Amendment 2:2019. This edition constitutes a technical revision.
This edition includes editorial and technical changes to reflect the IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-54:2022. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows:
a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER as in IEC 60601-2-54:2022;
b) several terms and definitions that are moved from IEC TR 60788:2004 to 201.3 of IEC 60601-2-54:2022 are also referenced from IEC 60601-2-54:2022.
c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares;
d) the former subclause 201.11.101 “Protection against excessive temperature of X-RAY TUBE ASSEMBLIES” is removed since covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017, and the former subclause 201.11.102 is renumbered as 201.11.101, as in IEC 60601-2-54:2022;
e) to adopt changes in subclause 7.8.1 “Colours of indicator lights” in IEC 60601 1:2005/AMD2:2020, clarification of requirements is provided in 201.7.8.1 to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT, as in IEC 60601-2-54:2022;
f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL CONDITIONS and SINGLE FAULT CONDITIONS.

  • Standard
    192 pages
    English language
    sale 15% off
  • Standard
    126 pages
    English and French language
    sale 15% off
IEC
IEC 60806:2022(Main)
Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis

IEC 60806:2022 is applicable to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES.
This document specifies a method for the determination of the greatest geometrically symmetrical RADIATION FIELD at a specified distance from the FOCAL SPOT for which the percentage AIR KERMA RATE along the major axes of the RADIATION FIELD does not fall below a permitted value.
In case multiple FOCAL SPOTS are not super-imposed, each FOCAL SPOT has its own REFERENCE AXIS. Then the maximum RADIATION FIELD can be given for each FOCAL SPOT separately.
IEC 60806:2022 cancels and replaces the first edition published in 1984. This edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous edition:
a) addition of solid state detectors as they have become more common since the first edition of 1984.

  • Standard
    21 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-54:2022(Main)
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

IEC 60601-2-54:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this document. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this document. The scope of this document also excludes radiotherapy simulators. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. IEC 60601-2-54:2022 edition cancels and replaces the first edition published in 2009, Amendment 1:2015 and Amendment 2:2018. This edition constitutes a technical revision. This edition includes editorial and technical changes to reflect the IEC 60601 1:2005/AMD2:2020. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows:
a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER;
b) terms and definitions taken exclusively from IEC TR 60788:2004 and which are specifically applicable in this document have been moved to 201.3;
c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares;
d) the subclause 201.11.101 “Protection against excessive temperatures of X-ray tube assemblies” has been removed from this document as its requirements are sufficiently and clearly covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017;
e) to adopt changes which are introduced with respect to indicator lights in 7.8.1 of the IEC 60601-1:2005/AMD2:2020 clarification of requirements is provided to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT;
f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS. CONDITIONS.

  • Standard
    243 pages
    English language
    sale 15% off
  • Standard
    161 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-45:2011/AMD2:2022(Amendment)
Amendment 2 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
  • Standard
    17 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-45:2011(Main)
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

IEC 60601-2-45:2011 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment.

  • Standard
    105 pages
    English language
    sale 15% off
  • Standard
    103 pages
    English and French language
    sale 15% off
  • Standard
    206 pages
    English and French language
    sale 15% off
  • Standard
    228 pages
    English and French language
    sale 15% off
IEC
IEC 62985:2019/COR1:2022(Corrigendum)
Corrigendum 1 - Methods for calculating size specific dose estimates (SSDE) for computed tomography
  • Standard
    1 page
    English and French language
    sale 15% off
IEC
IEC 61223-3-5:2019/COR1:2022(Corrigendum)
Corrigendum 1 - Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment
  • Standard
    1 page
    English and French language
    sale 15% off