11.040.50 射线照相设备 标准查询与下载



共找到 1766 条与 射线照相设备 相关的标准,共 118

Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs

ICS
11.040.50
CCS
发布
2022-03-18
实施

1   Scope and object This part of IEC 61223 applies to dental cone-beam computed tomography x-ray equipment , hereafter also called dental CBCT equipment , that conforms to IEC 60601‑2‑63:2012+AMD1:2017+AMD2:2021. NOTE 1 D ental CBCT equipment is a subset of D ental extra-oral X- ray equipment . NOTE 2 D ental extra-oral x-ray equipment can provide one or more of panoramic , cephalometric , tomosynthesis and D ental CBCT imaging modalities, all of which are in the scope of the IEC 60601‑2‑63 basic safety and performance standard. This document applies to acceptance tests and constancy tests on dental cone-beam computed tomography x-ray equipment . The aim of ...

Evaluation and routine testing in medical imaging departments - Acceptance and constancy tests. Imaging performance of X-ray equipment for dental cone beam computed tomography

ICS
11.040.50
CCS
发布
2022-02-28
实施
2022-02-28

This part of IEC 61223 applies to DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT, hereafter also called DENTAL CBCT EQUIPMENT, that conforms to IEC 60601-2-63:2012 and IEC 60601-2-63:2012/AMD1:2017. NOTE 1 DENTAL CBCT EQUIPMENT is a subset of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. NOTE 2 DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide one or more of PANORAMIC, CEPHALOMETRIC, tomosynthesis and DENTAL CBCT imaging modalities, all of which are in the scope of the IEC 60601-2-63 basic safety and performance standard. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT. The aim of 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 requirements specified in this document are minimal requirements. The MANUFACTURER can establish criteria for the tests described here that exceed the levels contained in this document. CONSTANCY TESTS are performed to ensure that the functional performance of ME EQUIPMENT meets established criteria and to enable the early recognition of changes in the properties of components of the ME EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. This document also contains requirements for the ACCOMPANYING DOCUMENTS associated with ACCEPTANCE AND CONSTANCY TESTING of the DENTAL CBCT EQUIPMENT. This document does not apply to: - aspects of thermal, EMD (electromagnetic disturbances), mechanical and electrical safety; - aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and directly affect image quality, RADIATION OUTPUT and PATIENT positioning. NOTE 3 Such aspects are generally addressed by IEC 60601-1 (all parts). Equipment in the scope of IEC 61223-3-5 is excluded from the scope of this document. DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide modalities which are in the scope of IEC 61223-3-4. In this case, the respective clauses of the IEC 61223-3-4 apply. The object of this document is to establish: - the essential parameters which describe the performance of DENTAL CBCT EQUIPMENT with regard to the image quality, RADIATION OUTPUT and PATIENT positioning; - methods of testing and whether measured quantities related to those parameters comply with the specified requirements. These methods rely on non-invasive measurements performed once the installation or a MAJOR SERVICE ACTION is completed.

Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography

ICS
11.040.50
CCS
发布
2022-02-04
实施
2022-04-11 (7)

1.1 This practice describes the evaluation of Digital Detector Arrays (DDAs), and assures that one common standard exists for quantitative comparison of DDAs so that an appropriate DDA is selected to meet NDT requirements. 1.2 This practice is intended for use by manufacturers or integrators of DDAs to provide quantitative results of DDA characteristics for NDT user or purchaser consumption. Some of these tests require specialized test phantoms to assure consistency among results among suppliers or manufacturers. These tests are not intended for users to complete, nor are they intended for long term stability tracking and lifetime measurements. However, they may be used for this purpose, if so desired. NOTE 1—Further information on application of DDAs is contained in Guide E2736 and Practices E2698 and E2737. 1.3 The results reported based on this practice should be based on a group of at least three individual detectors for a particular model number. 1.4 Units—The values stated in either SI units or inchpound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Practice for Manufacturing Characterization of Digital Detector Arrays

ICS
11.040.50
CCS
发布
2022-01-01
实施

This document applies to acceptance tests on digital mammography equipment. This document does not apply to the subsequent digitalisation of film images. Nor does it apply to mammographic stereotactic devices and special accessories for biopsy.

Image quality assurance in diagnostic X-ray departments - Part 162: Acceptance test of digital mammography installations

ICS
11.040.50
CCS
发布
2022-01-00
实施

This document specifies the concept of an intended series of standards to ensure the material-dependent and equipment-related image quality. It defines 3 levels of quality assurance: 1. Constancy test: Simple testing of the image generating system to maintain a given image qualit

Image quality assurance in diagnostic X-ray departments - Part 1: General

ICS
11.040.50
CCS
发布
2022-01-00
实施

This part of DIN 6868 specifies the performance of the acceptance test on medical X-ray equipment for fluoroscopy and imaging. It includes X-ray equipment for digital subtraction angiography. Also included are devices with integrated digital volume tomography and devices for digi

Image quality assurance in diagnostic X-ray departments - Part 150: Acceptance test of medical radiographic and fluoroscopic X-ray equipment

ICS
11.040.50
CCS
发布
2022-01-00
实施

This document specifies the performance of the acceptance test on dental X-ray equipment for dental digital volume tomography. It applies to equipment with image recording by X-ray image intensifiers and flat detectors. This document does not apply to devices which operate on the

Image quality assurance in diagnostic X-ray departments - Part 161: Acceptance testing of dental radiographic equipment for digital cone-beam computed tomography

ICS
11.040.50
CCS
发布
2022-01-00
实施

This document applies to constancy tests on digital mammography equipment in projection mode. This document specifies a method for testing the constancy of relevant parameters of digital mammography equipment without mechanical or electrical intervention. This document does not a

Image quality assurance in diagnostic X-ray departments - Part 14: Constancy testing of X-ray installations for digital mammography

ICS
11.040.50
CCS
发布
2022-01-00
实施

Nuclear medicine instrumentation — Routine tests —Part 3: Positron emission tomographs

ICS
11.040.50
CCS
发布
2021-12-28
实施

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

ICS
11.040.50
CCS
发布
2021-12-28
实施

Evaluation and routine testing in medical imaging departments —Part 1: General aspects

ICS
11.040.50
CCS
发布
2021-12-28
实施

Nuclear medicine instrumentation — Routine tests —Part 4: Radionuclide calibrators

ICS
11.040.50
CCS
发布
2021-12-28
实施

Nuclear medicine instrumentation — Routine tests —Part 2: Scintillation cameras and single photon emission computed tomography imaging

ICS
11.040.50
CCS
发布
2021-12-28
实施

Stethoscopes

ICS
11.040.50
CCS
发布
2021-12-28
实施

Abdominal speculum

ICS
11.040.50
CCS
发布
2021-12-28
实施

Nuclear medicine instrumentation — Routine tests —Part 2: Scintillation cameras and single photon emission computed tomography imaging

ICS
11.040.50
CCS
发布
2021-12-28
实施

Evaluation and routine testing in medical imaging departments —Part 1: General aspects

ICS
11.040.50
CCS
发布
2021-12-28
实施

Nuclear medicine instrumentation — Routine tests —Part 4: Radionuclide calibrators

ICS
11.040.50
CCS
发布
2021-12-28
实施

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

ICS
11.040.50
CCS
发布
2021-12-28
实施



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