11.040.50 射线照相设备 标准查询与下载



共找到 1767 条与 射线照相设备 相关的标准,共 118

Rotational type 60Co teletherapy apparatus

ICS
11.040.50
CCS
发布
20180615
实施
20180615

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy; Amendment 2

ICS
11.040.50
CCS
C43
发布
2018-06-01
实施
2018-07-10

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

ICS
11.040.50
CCS
C43
发布
2018-06-01
实施

本标准规定了乳腺X射线机(以下简称乳腺机)的术语、分类、要求和试验方法。 本标准适用于使用具有X射线胶片增感屏,采用接触式和放大式操作的乳腺摄影X射线机,该机专供医疗单位作乳腺X射线摄影之用。 本标准不适用于数字成像装置、活组织检查板和立体定位装置等专用附件。

Particular specifications for mammographic X-ray equipment

ICS
11.040.50
CCS
C43
发布
2018-04-01
实施
2018-04-01

1.1 This practice establishes the minimum requirements for radiographic examination of metallic and nonmetallic materials using digital detector arrays (DDAs). 1.2 The stated requirements of this specification are based on the use of an X-ray generating source. Additionally, some of the tests and requirements may not be applicable to X-ray energy levels >450kV. 1.3 The requirements in this practice are intended to control the quality of radiographic examinations obtained using DDAs and are not intended to establish acceptance criteria for parts or materials. 1.4 This practice covers the radiographic examination with DDAs including DDAs described in Practice E2597/E2597M such as a device that contains a photoconductor attached to a Thin Film Transistor (TFT) read out structure, a device that has a phosphor coupled directly to an amorphous silicon read-out structure, and devices where a phosphor is coupled to a CMOS (complementary metal–oxide–semiconductor) array, or a CCD (charge coupled device) crystalline silicon read-out structure. 1.5 The requirements of this practice and Practice E2737 shall be used together. The requirements of Practice E2737 will provide the baseline evaluation and long term stability test procedures for the DDA system. The user of the DDA system shall establish a written procedure that addresses the specific requirements and tests to be used in their application and shall be approved by the Cognizant Radiographic Level 3 before examination of production hardware. This practice also requires the user to perform a system qualification suitable for its intended purpose and to issue a system qualification report (see 9.1). 1.6 The DDA shall be selected for an NDT application based on knowledge of the technology described in Guide E2736, and of the selected DDA properties provided by the manufacturer in accordance with Practice E2597/E2597M. 1.7 Techniques and applications employed with DDAs are diverse. This practice is not intended to be limiting or restrictive. Refer to Guides E94/E94M, E1000, and E2736, Terminology E1316, Practices E747 and E1025, and Federal Standards 21-CFR-1020.40 and 29-CFR-1910.96 for a list of documents that provide additional information and guidance. 1.8 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 Radiographic Examination Using Digital Detector Arrays

ICS
11.040.50
CCS
发布
2018-02-01
实施

1.1 The image quality and the resolution of X-ray images highly depend on the characteristics of the focal spot. The imaging qualities of the focal spot are based on its two dimensional intensity distribution as seen from the imaging place. 1.2 This test method provides instructions for determining the effecting size (dimensions) of mini and micro focal spots of industrial X-ray tubes. It is based on the European standard, EN 12543–5, Non-destructive testing Characteristics of focal spots in industrial X-ray systems for use in non-destructive testing Part 5: Measurement of the effective focal spot size of mini and micro focus X-ray tubes. 1.3 This standard specifies a method for the measurement of effective focal spot dimensions from 5 up to 300 µm of X-ray systems up to and including 225 kV tube voltage, by means of radiographs of edges. Larger focal spots should be measured using Test Method E1165 Standard Test Method for Measurement of Focal Spots of Industrial X-Ray Tubes by Pinhole Imaging. 1.4 The same procedure can be used at higher kilovoltages by agreement, but the accuracy of the measurement may be poorer. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. 1.7 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 Test Method for Measurement of the Effective Focal Spot Size of Mini and Micro Focus X-ray Tubes

ICS
11.040.50
CCS
发布
2018-02-01
实施

1.1 This practice describes the evaluation of DDA systems for industrial radiology. It is intended to ensure that the evaluation of image quality, as far as this is influenced by the DDA system, meets the needs of users, and their customers, and enables process control and long term stability of the DDA system. 1.2 This practice specifies the fundamental parameters of Digital Detector Array (DDA) systems to be measured to determine baseline performance, and to track the long term stability of the DDA system. 1.3 The DDA system performance tests specified in this practice shall be completed upon acceptance of the system from the manufacturer and at intervals specified in this practice to monitor long term stability of the system. The intent of these tests is to monitor the system performance for degradation and to identify when an action needs to be taken when the system degrades by a certain level. 1.4 The use of the gages provided in this standard is mandatory for each test. In the event these tests or gages are not sufficient, the user, in coordination with the cognizant engineering organization (CEO) may develop additional or modified tests, test objects, gages, or image quality indicators to evaluate the DDA system. Acceptance levels for these ALTERNATE tests shall be determined by agreement between the user, CEO and manufacturer. 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 Digital Detector Array Performance Evaluation and Long-Term Stability

ICS
11.040.50
CCS
发布
2018-02-01
实施

Standard Practice for Radiographic Examination Using Digital Detector Arrays

ICS
11.040.50
CCS
发布
2018-02-01
实施

Special technical conditions for mobile C-arm X-ray machines

ICS
11.040.50
CCS
C43
发布
2018-01-19
实施
2019-01-01

This part of IEC 61948 describes test methods for POSITRON EMISSION TOMOGRAPHS (PET). As part of QUALITY CONTROL, this document is defining ROUTINE TESTS to be performed by the user of POSITRON EMISSION TOMOGRAPHS to maintain proper operation conditions. The results of these ROUTINE TESTS are compared to the REFERENCE DATA determined during or after ACCEPTANCE TEST. Methods used for ACCEPTANCE TESTS are described in IEC 61675-1:2013. In addition, today a POSITRON EMISSION TOMOGRAPH often includes X-RAY EQUIPMENT for COMPUTED TOMOGRAPHY (CT). For this document, PET/CT hybrid devices are considered to be state of the art, dedicated POSITRON EMISSION TOMOGRAPHS not including the X-ray component being special cases only. QUALITY CONTROL tests specific to only the CT component of the PET/CT are described in IEC 61223-2-6. The CT SCANNER also is subject to a TYPE TEST according to IEC 60601-1 and applicable collateral and particular standards.

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

ICS
11.040.50
CCS
C43
发布
2018-01-01
实施

Medical electrical equipment-Guidelines for implementation of DICOM in radiotherapy

ICS
11.040.50
CCS
发布
20171229
实施
20171229

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

ICS
11.040.50
CCS
发布
2017-12-29
实施

Medical electrical equipment-Dosimeters with ionization chambers as used in radiotherapy

ICS
11.040.50
CCS
发布
2017-12-29
实施

Medical electrical equipment — Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

ICS
11.040.50
CCS
发布
2017-12-29
实施

Medical electrical equipment — Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

ICS
11.040.50
CCS
发布
2017-12-29
实施

Vaginal specula

ICS
11.040.50
CCS
发布
2017-12-29
实施

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

ICS
11.040.50
CCS
发布
2017-12-29
实施

Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis

ICS
11.040.50
CCS
发布
2017-12-29
实施

Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis

ICS
11.040.50
CCS
发布
2017-12-29
实施

Tonsilotomes

ICS
11.040.50
CCS
发布
2017-12-29
实施



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