C41 医用超声、激光、高频仪器设备 标准查询与下载

YY/T 1089-2007 单元式脉冲回波超声换能器的基本电声特性和测量方法

本标准规定了单元式脉冲回波超声换能器的术语和定义、基本电声特性及其测量方法。 本标准适用于发收兼用的压电型单元式脉冲回波超声换能器，其有效辐射面的直径不大于 30 mm，工作频率范围为 1MHz～10MHz。

Electroacoustic characteristics and measurement methods of single element pulse-echo ultrasonic transducers

YY/T 1088-2007 在0.5MHz至15MHz频率范围内采用水听器测量与表征医用超声设备声场特性的导则

本标准就 0.5MHz 至 15 MHz 频率范围内采用水听器法对各类医用超声设备声输出进行的实际测量提供了指南。 本标准给出了医用超声设备声输出测量的简化步骤和指南，以及对因使用有限带宽和有限敏感元件尺寸的水听器所引起的限制进行修正的步骤。

Guidance for the measurement and characterization of ultrasonic fields generated by medical ultrasonic equipment using hydrophones in the frequency range 0.5MHz to 15MHz

IEC 60601-2-2:2006 医用电气设备.第2-2部分:高频外科医疗设备的安全性特殊要求

This Particular Standard specifies requirements for the safety of HIGH FREQUENCY SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES used in medical practice, as defined in 2.1.110 and hereinafter referred to as HF SURGICAL EQUIPMENT. HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this Particular Standard. These exemptions are indicated in the relevant requirements.

Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment

IEC 61391-1:2006 超音波学.脉冲反射扫描仪.第1部分:系统点传播功能响应的校准空间测量系统和测量

This International Standard describes methods of calibrating the spatial measurement facilities and point-spread function of ultrasonic imaging equipment in the ultrasonic frequency range 0,5 MHz to 15 MHz. This standard is relevant for ultrasonic scanners based on the pulse-echo principle of the types listed below: − mechanical sector scanners; − electronic phased-array sector scanners; − electronic linear-array scanners; − electronic curved-array sector scanners; − water-bath scanners based on any of the above four scanning mechanisms; − 3D-volume reconstruction systems.

Ultrasonics - Pulse echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response

NF C74-335/A2:2006 医用电气设备.第2-37部分:超声波医疗诊断和监控设备安全的特殊要求

Medical electrical equipment - Part 2-37 : particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.

NF C97-910*NF EN 61846:2006 超声波.压力脉冲碎石器.电磁场特性

Ultrasonics - Pressure pulse lithotripters - Characteristics of fields.

IEC TS 62306:2006 超声波学.野外特性.在诊断超声波场内测定温度上升的试验目标

This Technical Specification is applicable to medical diagnostic ultrasonic fields. This Technical Specification establishes: – the important characteristics and terminology for test objects containing an embedded thermal sensor to determine ultrasonic heating; – requirements for defining particular types of test object for specific applications; – examples of design features which will ensure that the performance specifications are achieved; – validation procedures; – general test methods for using test objects to determine standardised temperature rises. NOTE 1 This Technical Specification specifically relates to test objects which contain an embedded thermal sensor (such as a thermocouple or thermistor). Although it may be possible to use non-embedded methods of temperature determination to achieve the same ends, these are outside of the scope of this Technical Specification. NOTE 2 The test objects specified in this Technical Specification are for the measurement of temperature rise and not for the determination of Thermal Index which is, by definition, an algebraic combination of acoustical field quantities and is therefore not a physically measurable quantity.

Ultrasonics - Field characterisation - Test objects for determination temperature elevation in diagnostic ultrasonic fields

NF C74-338*NF EN 61828:2006 超声.聚焦传感器.定义和传送场的测量方法

Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields.

NF C97-911*NF EN 61847:2006 超声学.外科器械.基本输出特性的测量和标示

Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics.

BS EN 62359:2005 超声波学.场特征.医疗诊断超声场相关热和机械指数测定的试验方法

This International Standard is applicable to medical diagnostic ultrasound fields. This standard establishes – parameters related to thermal and non-thermal aspects of diagnostic ultrasonic fields; – methods for the determination of an exposure parameter relating to temperature rise in theoretical tissue-equivalent models, resulting from absorption of ultrasound; – methods for the determination of an exposure parameter appropriate to certain nonthermal effects. NOTE In this standard where multiples or submultiples of SI units are used this is clearly stated and the usage is self-consistent.

Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

KS C IEC 61847:2005 超声学.外科装置.基本输出特性的测量和标示

이 규격은 외과용 초음파 장치의 다음 사항들을 규정한다.-가장 기본적인 비열적 출력 특

Ultrasonics－Surgical systems－Measurement and declaration of the basic output characteristics

KS C IEC 61846:2005 超音波学.压力脉冲碎石器.声场特性

이 규격은 외용적으로 유도된 압력파를 이용한 결석 쇄석 제거 장비와 초점을 맞춘 역학 에너

Ultrasonics－Pressure pulse lithotripters－Characteristics of fields

KS C IEC 61689:2005 超音波学.物理疗法系统.频率范围0.5MHz~5MHz的现场规范和测量方法

이 규격은 0.5~5 MHz 주파수 영역의 연속 또는 준연속 파장의 초음파 에너지를 발생시

Ultrasonics－Physiotherapy systems－Performance requirements and methods of measurement in the frequency range 0.5 MHz to 5 MHz

YY/T 0111-2005 超声多普勒换能器技术要求和试验方法

本标准规定了超声多普勒换能器的产品分类、要求及试验方法。 本标准适用于医用超声多普勒胎儿诊断及监护设备所配用的压电型超声多普勒换能器，其有效工作面积(包括发射和接收)的半径为3mm～30mm，超声工作频率范围为0.8MHz～8.O MHz。

Technical requirements and test methods for ultrasonic Doppler transducer

YY 0593-2005 超声经颅多普勒血流分析仪

本标准规定了超声经颅多普勒血流分析仪的术语和定义、产品分类、要求、试验方法、检验规则以及标志和使用说明书。 本标准适用于超声经颅多普勒血流分析仪(以下简称TCD仪)。

Ultrasound transcranial Doppler system

YY/T 0163-2005 医用超声测量水听器特性和校准

本标准规定了0.5MHz～10MHz频率范围内，采用压电传感元件测量医用超声设备在水中产生的脉冲的或连续波超声场的水听器的术语和定义、产品分类、要求和校准方法。 本标准适用的水听器是一种已知灵敏度且具有高频宽频带频率响应的水下声接收器。它由圆片形的压电传感元件，声学结构件，外壳，电缆和插头组成。有针形和薄膜形两种主要结构形式。

Characteristics and calibration of hydrophones for medical ultrasonic fields

YY 0107-2005 眼科A型超声测量仪

本标准规定了眼科A型超声测量仪的产品分类、要求、试验方法、检验规则以及使用说明书。 本标准适用于采用A型显示的超声眼科测量仪(以下简称“测量仪”)，该产品主要用于眼科角膜厚度和眼轴长度的测量。

A mode ultrasonic biometer for ophthalmology

YY 0592-2005 高强度聚焦超声(HIFU)治疗系统

本标准规定了高强度聚焦超声(HIFU)治疗系统的术语和定义、分类、要求、试验方法、检验规则以及标志、包装、运输和贮存。 本标准适用于声工作频率范围0.5MHz～2.0MHz体外聚焦的高强度聚焦超声(HIFU)治疗系统(以下简称HIFU治疗系统)。

High intensity focused ultrasound therapy system

IEC 60601-2-37/AMD2:2005 医用电气设备.第2-37部分:超声医疗诊断和监护设备安全性的特殊要求.修改件2

Addition:This Particular Standard specifies particular safety requirements for ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 2.1.145.This standard does not cover ultrasonic therapeutic equipment; however@ equipment used for the imaging of body structures by ultrasound in conjunction with therapeutic modalities is covered.

Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment; Amendment 2

IEC 60601-2-5:2005 医用电气设备.第2-5部分:超声波理疗设备安全性的特殊要求

Addition: This Particular Standard specifies the requirements for safety of ULTRASONIC PHYSIOTHERAPY EQUIPMENT used in medical practice, as defined in 2.1.101. This Particular Standard does not apply to: - EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry); - EQUIPMENT in which focused ULTRASOUND pulse waves are used to destroy conglom-erates such as stones in the kidneys or the bladder (lithotrites) (for information refer to IEC 60601-2-36); - ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ULTRASOUND pulse waves are used.

Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment