11.040.50 射线照相设备 标准查询与下载

T/CAME 6-2019 PET/MR质量控制检测规范

1.范围，2.规范性引用文件，3.术语和定义，4.检测项目及技术要求，5.PET检测方法，6.MRI检测方法，7.PET/MR图像配准精度检测方法

Specification of quality control for PET/MR

T/CAME 10-2019 正电子发射X射线计算机断层成像系统（PET/CT）图像融合软件临床应用质量检测技术规范

本标准规定了正电子发射X射线计算机断层成像系统的检测条件、技术要求、检测方法及评价、检测周期、检测记录与结果处理。

Specification for clinical application quality testing in image fusion software of positron emission tomography and computed tomography（PET/CT）

T/CAME 7-2019 X射线计算机断层摄影装置（CT）心血管成像软件临床应用质量检测技术规范

本标准规定了X 射线计算机断层摄影装置（CT）心血管成像软件临床应用的检测条件、技术要求、检测方法及评价、检测周期、检测记录与结果处理。

Specification for clinical application quality testing in cardiovascular imaging software of X-ray computed tomography

T/CAME 4-2019 MRI质量控制体模技术规范

1.范围，2.规范性引用文件，3.术语和定义，4.MRI体模的技术要求，5.MRI体模的测试方法，附录A（资料性附录）有源磁共振功能成像（fMRI）质量控制体模，附录B（规范性附录）磁共振功能成像（fMRI）的质量控制测试方法

Technical specification for MRI quality control phantom

YY/T 0448-2019 超声多普勒胎儿心率仪

Ultrasound Doppler Fetal Heart Rate Monitor

IEC TR 62926:2019 医用电气系统.实时自适应放射治疗用自适应外束放射治疗系统的安全集成和操作指南

This document provides guidelines for safe integration and operation of an adaptive external-beam RADIOTHERAPY system (AEBRS) for intra-fractionally moving rigid TARGET VOLUMEs@ where required equipment can be sourced from one or several MANUFACTURERs. In particular it addresses guidelines to help ensure safe integration and operation for the PATIENT@ OPERATOR@ other persons and sensitive devices in the vicinity. In this document@ the word ??system?? is hereafter used to refer to an AEBRS. This document specifies the safety guidelines for a MANUFACTURER or RESPONSIBLE ORGANIZATION who integrates the AEBRS for intra-fractionally moving rigid TARGET VOLUMEs. If a RESPONSIBLE ORGANIZATION integrates an AEBRS@ then it takes the role of MANUFACTURER and will be referred to as a MANUFACTURER throughout this document. This document includes reference models of the AEBRS for intra-fractionally moving rigid TARGET VOLUMEs and HAZARDs which@ at a minimum@ are considered during the RISK ANALYSIS. Although TARGET VOLUMES and OARs can deform during motion@ adaptations in response to deformations of the TARGET VOLUME are out of the scope of this document. The scope is limited to rigid TARGET VOLUMEs exhibiting intra-fractional movements@ both translational and rotational. While technical HAZARDs are discussed in this document@ the RESPONSIBLE ORGANIZATION is reminded that clinical judgement is always employed when determining clinical usability and reviewing TREATMENT PARAMETER changes. This document does not specifically address HAZARD mitigations for each of the HAZARDs mentioned in the document; however@ some mitigations are given as examples in Clauses 4 and 5. All guidelines in this document are intended to be implemented in accordance with the general standard IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012@ with special attention to 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

Medical electrical system - Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy

BS EN IEC 62464-1:2019 用于医学成像的磁共振设备 确定基本图像质量参数

What is BS EN IEC 62464‑1- Determination of essential image quality parameters about?    BS EN IEC 62464 is a standard that discusses m agnetic resonance equipment for medical imaging. BS EN IEC 62464‑1 provides the best industry guidance on the determination of essential image quality parameters to ensure high-quality magnetic resonance equipment.   BS EN IEC 62464‑1 is the first part of a multi-part series that specifies measurement procedures for the determination of many essential image quality parameters for magnetic resonance equipment . Measurement procedures as addressed under BS EN IEC 62464‑1

Magnetic resonance equipment for medical imaging. Determination of essential image quality parameters

IEC TR 61948-4:2019 核医学仪器常规试验第4部分:放射性核素校准器

This part of IEC 61948 covers the ROUTINE TESTING of RADIONUCLIDE CALIBRATORS used in nuclear medicine. Such devices utilise ionisation chambers of the well type and a direct readout in units of ACTIVITY. Requirements and specific methods to determine performance parameters are described in IEC 61303. These methods are primarily designed for ACCEPTANCE TESTING

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

IEC TR 61948-4:2019 RLV 核医学仪器常规试验第4部分:放射性核素校准器

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

JIS T 60601-2-63:2019 医疗电气设备. 第2-63部分: 牙科口腔外X射线设备基本安全性和基础性能详细要求

Medical electrical equipment -- Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

YY/T 1635-2018 多道生理记录仪

multi-channel physiological recorder

YY/T 1625-2018 移动式X射线计算机体层摄影设备专用技术条件

Special technical conditions for mobile X-ray computed tomography equipment

YY/T 0865.2-2018 超声 水听器 第2部分：40MHz以下超声场用水听器的校准

Ultrasonic hydrophones Part 2: Calibration of hydrophones for ultrasonic fields below 40 MHz

IEC 62464-1:2018 医学成像磁共振00716716设备 - 第1部分:基本图像质量参数的确定

This part of IEC 62464 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 ?C quality assessment in the ACCEPTANCE TEST@ and ?C quality assurance in the CONSTANCY TEST. Required levels of performance for ACCEPTANCE TESTS are not provided for all tests. This document does not address ?C image quality assessment of MR EQUIPMENT with a static magnetic field intensity greater than 8 Tesla@ if not otherwise stated@ ?C image quality affected by MR-compatibility issues@ ?C special diagnostic procedures such as flow imaging@ perfusion@ diffusion@ radiotherapy and image-guided therapy applications@ and ?C 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 ?C MANUFACTURERS@ who can demonstrate compliance by performing ACCEPTANCE and CONSTANCY TESTS as described by this document@ ?C test houses@ who can confirm performance of MR EQUIPMENT using methods described in this document@ ?C regulatory authorities@ who can reference this document@ and ?C 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 ?C SIGNAL TO NOISE RATIO@ ?C UNIFORMITY@ ?C SLICE THICKNESS in 2-D scanning@ ?C 2-D GEOMETRIC DISTORTION@ ?C SPATIAL RESOLUTION@ and ?C 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. NOTE None of the methods found in this document have been extensively tested at a static magnetic field intensity above 3 T. Initial tests indicate the methods function correctly when appropriate TEST DEVICE fillers are used.

Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters

DB31/T 1116-2018 18F-FDG PET/CT肿瘤显像报告要素规范

本标准规定了氟[18]-脱氧葡萄糖正电子发射断层显像/X线计算机断层显像仪（18F-FDG positron emission tomography/x-ray computed tomography, 简称18F-FDG PET/CT）肿瘤显像报告内容的基本信息、简要病史、采集信息、影像描述、对比及报告结论等基本要素规范。 本标准适用于本市配置PET/CT的医疗机构所出具的18F-FDG PET/CT肿瘤显像报告（以下简称报告）。

18F-FDG PET/CT tumor imaging report element specification

YY/T 0449-2018 超声多普勒胎儿监护仪

Ultrasound Doppler fetal monitor

YY/T 0590.1-2018 医用电气设备 数字X射线成像装置特性 第1-1部分：量子探测效率的测定 普通摄影用探测器

YY/T 0590的本部分规定了数字X射线成像装置量子探测效率(DQE)的测定方法。在制造商规定的医疗应用范围内的工作条件下量子探测效率(DQE)是照射量和空间频率的函数。 本部分适用于那些产生用于医疗诊断的数字格式影像的数字X射线成像装置。本部分的适用范围限于用于单次曝光成像的数字X射线摄影装置，例如CR系统、基于硒材料的成像系统，平板探测器，光学耦合CCD成像系统以及数字X射线影像增强器。 本部分不适用于： —乳腺摄影和牙科摄影用数字X射线成像装置； —计算机体层摄影设备； —对人体进行扫描成像的X线系统； —动态成像设备(在该系统中一系列影像被采集到，例如透视和心脏成像)。 上述设备不包括在本部分中是因为他们的许多参数(如辐射质量、几何关系、时间依赖性等)与常规的X射线摄影有很大区别，这些参数由已经完成的用于其他主题的各自的标准来规范，如同IEC和ISO中对感光速度和对比度的单独规定。

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency

YY/T 0609-2018 医用诊断X射线管组件通用技术条件

本标准规定了医用诊断X射线管组件的分类、要求及试验方法。 本标准适用于医用诊断X射线管组件（以下简称X射线管组件）。该产品供医用诊断X射线设备配套使用。

General specifications of medical diagnostic X-ray tube assemblies

YY/T 0741-2018 数字化摄影X射线机专用技术条件

Special technical conditions for digital photography X-ray machines

KS C IEC 61675-2-2018 放射性核素成像装置 - 特性和测试条件 - 第2部分:单光子发射计算机断层扫描仪

Radionuclide imaging devices — Characteristics and test conditions — Part 2: Gamma cameras for planar, wholebody, and SPECT imaging