C41 医用超声、激光、高频仪器设备 标准查询与下载

BS EN 62127-2:2007 超音波学.水听器.第2部分:超音波场小于40MHz的校准

This part of IEC 62127 specifies: ? absolute hydrophone calibration methods; ? relative (comparative) hydrophone calibration methods. Recommendations and references to accepted literature are made for the various relative and absolute calibration methods in the frequency range covered by this standard. This standard is applicable to ? hydrophones used for measurements made in water and in the ultrasonic frequency range up to 40 MHz; NOTE 1 Although some physiotherapy medical applications of medical ultrasound are developing which operate in the frequency range 40 kHz to 100 kHz, the primary frequency range of diagnostic imaging remains above 2 MHz. It has recently been established that, even in the latter case, the hydrophone response at substantially lower frequencies can influence measurements made of key acoustic parameters [1]. ? hydrophones employing circular piezoelectric sensor elements, designed to measure the pulsed wave and continuous wave ultrasonic fields generated by ultrasonic equipment; NOTE 2 Some hydrophones can have non-circular active elements, arising from slight deviations from a circular structure caused, for example by electrode structure, or conversely, the active elements can actually be squares. The clauses within this standard remain valid, although, in these cases, special attention should be paid to the directional response and to the effective radii of the active element through various axes of rotation. ? hydrophones with or without a hydrophone pre-amplifier.

Ultrasonics — Hydrophones — Part 2: Calibration for ultrasonic fields up to 40 MHz

YY/T 0642-2008 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

本标准适用于1MHz至15MHz频率范围内的医用诊断超声场。 本标准规定了： —相关于诊断超声场热和非热的参数； —理论组织-等效模型中，由超声吸收引起的，相关于温升的辐照参数的确定方法； —与某些非热效应相关的辐照参数的确定方法。

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

YY/T 0644-2008 超声外科手术系统基本输出特性的测量和公布

本标准规定了： —超声波外科手术系统的主要非热输出特性； —输出特性的测量方法； —设备制造商应公布的特性参数。 本标准所适用的设备需同时满足下列a)、b)和c)的要求： a) 工作在20kHz至60kHz频率范围内； b) 用于对人体组织的破碎或切割（不管这些作用是否与组织的去除或凝固相关）； c) 声波通过专门设计的波导将能量传递到外科手术部位。 本标准不适用于： —由体外引入压力脉冲，经由液体煤质和人体软组织进行聚焦的碎石设备； —作为治疗过程某一部分的外科装置（温热疗系统）； —声学应用部位不在纵向振动治疗头尖端且因此不符合本标准使用的单级模型的外科装置。

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

YY/T 0643-2008 超声脉冲回波诊断设备性能测试方法

本标准定义了描述测量脉冲回波医用诊断系统性能的参数，并给出了测试方法。 本标准适用于在0.5MHz～25MHz超声频率范围内采用单阵元换能器的超声诊断设备。 本标准不适用于多普勒超声系统。

Methods of measuring the performance of ultrasonic plus-echo diagnostic equipment

YY/T 0108-2008 超声诊断设备M模式试验方法

本标准规定了超声诊断设备M模式的术语和定义、测试条件以及试验方法。 本标准适用于超声标称频率在2.0MHz～15.0MHz范围内，具备M模式功能的超声诊断设备。

Testing methods for M-mode of ultrasonic diagnostic equipment

NF C74-335*NF EN 60601-2-37:2008 医用电气设备.第2-37部分:医疗用超声波诊断和监测设备的基本安全性和基本性能的详细要求

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

BS DD IEC/TS 62306:2008 超声学.超声波场的特征.在诊断超声波场内测定温度上升用试验对象

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 determining temperature elevation in diagnostic ultrasound fields

BS EN 61157:2007+A1:2013 医疗诊断超声波设备声输出的报告用标准方法

Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment

BS EN 61689:2007 超音波学.物理疗法系统.频率范围0.5MHz～5MHz的超声波场规范和测量方法

This International Standard is applicable to ultrasonic equipment designed for physiotherapy consisting of an ultrasonic transducer generating continuous or quasi-continuous wave ultrasonic energy in the frequency range 0,5 MHz to 5 MHz. This standard only relates to ultrasonic physiotherapy equipment employing a single plane unfocused circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This standard specifies: – methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on reference testing methods; – characteristics to be specified by manufacturers of ultrasonic physiotherapy equipment based on reference testing methods; – guidelines for safety of the ultrasonic field generated by ultrasonic physiotherapy equipment; – methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on routine testing methods; – acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment based on routine testing methods. Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard.

Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz

BS EN 61157:2007 医疗诊断超声波设备声输出的报告用标准方法

This International Standard is applicable to medical diagnostic ultrasonic equipment. – It provides a set of traceable acoustic parameters describing the acoustic fields. – It defines a standard means and format for the reporting of the acoustic output information. – It also describes a reduced dataset recommended for equipment generating low acoustic output levels. NOTE The information tabulated in this standard format can be used for a) exposure planning for biological effects studies; b) exposure data for prospective epidemiological studies conducted using exposure conditions similar to those reported in this standard. In the absence of actual exposure data for retrospective epidemiological studies, the information tabulated in this standard format might also be used with cautionary comment.

Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment

DIN EN 60601-2-22 Bb.1:2007 激光制品的安全性.人类激光束的安全使用指南

Safety of laser products - Guidelines for the safe use of laser beams on humans (IEC/TR 60825-8:2006)

IEC 61157:2007 医疗诊断超声波设备声输出的报告用标准方法

This International Standard is applicable to medical diagnostic ultrasonic equipment. – It provides a set of traceable acoustic parameters describing the acoustic fields. – It defines a standard means and format for the reporting of the acoustic output information. – It also describes a reduced dataset recommended for equipment generating low acoustic output levels. NOTE The information tabulated in this standard format can be used for a) exposure planning for biological effects studies; b) exposure data for prospective epidemiological studies conducted using exposure conditions similar to those reported in this standard. In the absence of actual exposure data for retrospective epidemiological studies, the information tabulated in this standard format might also be used with cautionary comment.

Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment

IEC 60601-2-37:2007 医疗电气设备.第2-37部分:超声波医疗诊断和监测设备的基本安全和基本性能用特殊要求

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of this standard. NOTE See also subclause 4.2 of this standard. This particular standard does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered.

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC 61689:2007 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

This International Standard is applicable to ultrasonic equipment designed for physiotherapy consisting of an ultrasonic transducer generating continuous or quasi-continuous wave ultrasonic energy in the frequency range 0,5 MHz to 5 MHz. This standard only relates to ultrasonic physiotherapy equipment employing a single plane unfocused circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This standard specifies: – methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on reference testing methods; – characteristics to be specified by manufacturers of ultrasonic physiotherapy equipment based on reference testing methods; – guidelines for safety of the ultrasonic field generated by ultrasonic physiotherapy equipment; – methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on routine testing methods; – acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment based on routine testing methods. Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard.

Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz

IEC 60601-2-22:2007 医疗电气设备.第2-22部分:外科、整容、治疗和诊断用激光设备基本安全和基本性能的特殊要求

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a CLASS 3B or CLASS 4 LASER PRODUCT as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as LASER EQUIPMENT. Throughout this International Standard, light emitting diodes (LED) are included whenever the word “laser” is used. NOTE 1 Refer to Definition 3.49 in IEC 60825-1. NOTE 2 Laser products for these applications classified as a CLASS 1, 1M, 2, 2M or CLASS 3R LASER PRODUCT, are covered by IEC 60825-1 and IEC 60601-1. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the General Standard. NOTE See also 4.2 of the General Standard. This standard can also be applied to surgical, cosmetic, therapeutic and diagnostic laser equipment used for compensation or alleviation of disease, injury or disability.

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

DIN EN 61391-1:2007 超音波学.脉冲回波扫描仪.第1部分:校准空间测量系统和系统点传播功能响应测量

Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response (IEC 61391-1:2006); German version EN 61391-1:2006

IEC TS 62462:2007 超音波学.输出试验.超频率音响理疗设备的维护指南

This technical specification describes methods meant to assist users of ultrasound therapy machines in checking the performance of such machines. It is applicable primarily to physiotherapists, general medical practitioners, chiropractors, osteopaths, beauty therapists, sports professionals, biomedical engineers, medical physicists, medical device service agents, commercial testers, test houses or manufacturers. NOTE The titles of all publications referred to informatively in this technical specification are listed in the Bibliography.

Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems

JJG 893-2007 超声多普勒胎心仪超声源检定规程

本规程适用于超声多普勒胎心仪超声源（即超声多普勒胎儿心率仪，以下简称仪器）的首次检定、后续检定和使用中检验。

Verification Regulation of Ultrasonic Source of Ultrasonic Doppler Foetal Meters

YY/T 1084-2007 医用超声诊断设备声输出功率的测量方法

本标准规定了医用超声诊断设备声输出功率的测量方法，其中辐射力天平法为首选方法，在能够确保测量准确度的前提下，也可采用水听器法。 本标准适用于0.5MHz～15MHz频率范围内医用超声诊断设备声输出功率的测量。

Measurement methods of output power for medical diagnostic ultrasonic equipments

YY/T 1085-2007 毫瓦级超声源

本标准规定了毫瓦级超声源的术语和定义、分类、要求及试验方法。 本标准适用于用作医用超声功率标准的毫瓦级超声源（以下简称声源）。该声源由超声换能器和激励源组成，是一种稳定的、已知输出超声声功率的声源。该声源主要用于超声测量实验室对超声声功率测量装置和水听器测量系统有效性的日常比对和核查。

Ultrasonic sources at milliwatt levels