C41 医用超声、激光、高频仪器设备 标准查询与下载

GB 10152-1997 B型超声诊断设备

本标准规定了B型超声诊断设备的定义、要求、试验方法、检验规则以及标志、包装、贮存和运输。 本标准适用于频率范围在2～7.5MHz以内，采用B型成像方式的通用超声诊断设备（以下简称设备），该产品主要用于医学临床诊断。

B mode ultrasonic diagnostic equipment

GB 9706.9-1997 医用电气设备 医用超声诊断和监护设备专用安全要求

增加： 本标准规定了由2.1.124条所定义的医用超声诊断和监护设备的专用安全要求。本标准的适用范围不包括超声治疗设备，但与治疗设备联系在一起、利用超声对人体组织的成像设备应包括在内。

Medical electrical equipment--Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

GB/T 15261-1994 超声仿人体组织材料声学特性的测量方法

本标准规定了超声仿人体组织材料的声学特性参数及测量方法。 本标准适用于该材料标准样品密度及在1～10MHz频率范围内声速、声衰减系数的测量。

Methods of measuring the acoustic characteristics of ultrasonically tissue-mimicking materials

GB/T 15214-1994 医用B型超声诊断设备可靠性试验要求和方法

本标准规定了医用B型超声诊断设备可靠性试验的基本要求和试验方法。 本标准适用于失效规律服从指数分布的医用B型超声诊断设备的可靠性试验。

Requirements and methods of reliability test for medical B mode ultrasonic diagnostic equipment

GB 9706.7-1994 医用电气设备 超声治疗设备专用安全要求

本标准规定了医用超声治疗设备（如2.1.101的定义，以下简称设备）的安全要求。 本标准不适用于由超声波驱动的器械（如外科、齿科用设备）或用聚焦超声波粉碎结块（如肾结石或囊肿等）及超声肿瘤热疗设备。

Medical electrical equipment-Particular requirements for the safety of ultrasonic therapy equipment

YY/T 0773-2023 眼科B型超声诊断仪通用技术条件

本文件规定了眼科B型超声诊断仪的要求和试验方法。本文件适用于眼科B型超声诊断仪，其超声标称频率范围通常在10MHz～50MHz。

General technical conditions for ophthalmic B-mode ultrasonic diagnostic instruments

YY/T 0767-2023 彩色超声影像设备通用技术要求

本文件规定了彩色超声影像设备的要求，描述了相应的试验方法。本文件适用于彩色超声影像设备。

General technical requirements for color ultrasound imaging equipment

YY/T 1919-2023 超声造影成像性能试验方法

本文件描述了超声成像设备超声造影成像性能的试验条件和试验方法。本文件适用于具备造影功能的超声成像设备。本文件不适用于采用胃肠助显剂进行信号增强的超声成像设备。

Test methods for contrast-enhanced ultrasound imaging performance

YY 1289-2022 激光治疗设备 眼科激光光凝仪

本文件规定了眼科激光光凝仪的术语和定义、产品组成、要求、试验方法等内容。本文件适用于临床上进行眼底激光光凝治疗的设备。

Laser treatment equipment Ophthalmic laser photocoagulation device

YY/T 0642-2022 超声 声场特性 确定医用诊断超声场热和机械指数的试验方法

Test method for determining the thermal and mechanical indices of ultrasonic fields for medical diagnostic ultrasonic fields

DB32/T 4272-2022 医用超声测量用水处理指南

本文件提出了医用超声测量用水的基本要求、脱气处理、去离子处理、去微生物处理和去悬浮微粒 处理的建议。 本文件适用于医用超声测量用水的处理过程。

Guidelines for Water Treatment for Medical Ultrasonic Measurements

YY/T 0937-2022 超声仿组织体模的技术要求

Technical requirements for ultrasonic tissue-mimicking phantoms

YY/T 0593-2022 超声经颅多普勒血流分析仪

Transcranial doppler ultrasound system

NF C74-350*NF EN IEC 60601-2-50:2021 医疗用电气设备. 第2-50部分: 对于婴儿光照疗法设备的基本安全性和性能的特殊要求

Medical electrical equipment - Part 2-50 : particular requirements for the basic safety and essential performance of infant phototherapy equipmen

YY/T 1767-2021 超声 功率测量 高强度治疗超声（HITU）换能器和系统

Ultrasound Power Measurement High Intensity Therapeutic Ultrasound (HITU) Transducers and Systems

YY 9706.262-2021 医用电气设备 第2-62部分：高强度超声治疗（HITU）设备的基本安全和基本性能专用要求

Medical electrical equipment Part 2-62: Specific requirements for basic safety and essential performance of high-intensity therapeutic ultrasound (HITU) equipment

T/CSBME 024-2021 超声诊断设备可靠性试验方法

本文件规定了超声诊断设备可靠性试验的基本方法。 本文件适用于超声诊断设备的可靠性试验。

Reliability test methods for ultrasonic diagnostic equipment

ISO 23864:2021 焊接无损检测. 超声检测. 自动全聚焦技术(TFM)和相关技术的使用

This document specifies the application of the TFM technique and related technologies for semi- or fully automated ultrasonic testing of fusion- welded joints in metallic materials of minimum thickness 3,2 mm. NOTE Unless stated otherwise, in this document ‘TFM” and ‘TFM technique” refer to the TFM technique as defined in ISO 23243, and to all related technologies, see for example ISO 23865 and ISO 23243. This document is applicable to components with welds fabricated using metals which have isotropic (constant properties in all directions) and homogeneous conditions. This includes welds in low carbon alloy steels and common aerospace grade aluminium and titanium alloys, provided they are homogeneous and isotropic. This document applies to full penetration welded joints of simple geometry in plates, pipes and vessels. This document specifies four testing levels (A, B, C, D), each corresponding to a different probability of detection of imperfections. Guidance on the selection of testing levels is provided. Coarse-grained metals and austenitic welds can be tested when the provisions of this document have been taken into account. This document gives provisions on the specific capabilities and limitations of the TFM technique for the detection, locating, sizing and characterization of discontinuities in fusion-welded joints. The TFM technique can be used as a stand-alone approach or in combination with other non-destructive testing (NDT) methods for manufacturing, in-service and post-repair tests. This document includes assessment of indications for acceptance purposes based on either amplitude (equivalent reflector size) and length or height and length. This document does not include acceptance levels for discontinuities. The following two typical testing techniques for welded joints are referred to in this document: a) side scanning, where the probe(s) is (are) positioned adjacent to the weld cap, typically using wedges. Side scanning can be performed from one side or both sides of the weld; b) top scanning where the probe is positioned on top of weld cap with a flexible, conformable delay line or using immersion technique, or using contact technique after removing the weld cap. Semi-automated testing encompasses a controlled movement of one or more probes along a fixture (guidance strip, ruler, etc.), whereby the probe position is measured with a position sensor. The scan is performed manually. In addition, fully automated testing includes mechanized propulsion.  1 

Non-destructive testing of welds - Ultrasonic testing - Use of automated total focusing technique (TFM) and related technologies

YY/T 1751-2020 激光治疗设备 半导体激光鼻腔内照射治疗仪

Laser treatment equipment semiconductor laser intranasal irradiation therapy instrument

YY/T 1749-2020 基于外部振动的肝组织超声弹性测量设备

Ultrasonic elasticity measurement device of liver tissue based on external vibration