C41 医用超声、激光、高频仪器设备 标准查询与下载

YY/T 0756-2009 光学和光学仪器 激光和激光相关设备 激光光束功率（能量密度分布的试验方法

本标准规定了测量功率(能量)密度分布的方法，并定义了给定平面上激光功率(能量)密度分布函 数的特征参数。 本标准规定的方法适用于检测并描述光学和光学仪器中使用的连续激光和脉冲激光光束特性。

Optics and Optical Instruments Lasers and Laser-related Equipment Laser Beam Power (Test Method for Energy Density Distribution

BS EN 62359:2011 声学.声场特性.与医疗诊断超声场有关的热和机械指数测定的试验方法

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

IEC TS 62558:2011 超声波学.实时脉冲反射波扫描器.仿薄纱材质外圆人造囊仿真模型及其VDR(空鉴别比率)的三维分布定期试验和自动化求值方法

Ultrasonics - Real-time pulse-echo scanners - Phantom with cylindical, artificial cysts in tissue-mimikring material and method for automated evaluation and periodic testing of 3-D distributions of void-detectability ratio (VDR)

IEC 62359:2010/COR1:2011 超声波学.场特性.有关医学诊断超声波场的机械目录和热量测定用试验方法

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

ANSI Z136.3-2011 医疗保健中激光的安全使用标准

This standard provides guidance for the safe use of lasers in health care. Specific processes are provided to protect anyone who might become exposed to laser radiation and to assist in establishing a program that promotes the safe use of health care lasers.

Standard for Safe Use of Lasers in Health Care

YY 0774-2010 超声骨密度仪

本标准规定了超声骨密度仪的术语和定义、要求和测试方法。 本标准适用于采用超声透射法，测量人体跟骨中的声速和衰减特性来检测骨密度的超声骨密度仪。

Ultrasound bone sonometers

YY/T 0797-2010 超声 输出试验 超声理疗设备维护指南

本标准描述的方法用于协助超声理疗设备（以下简称“设备”）的使用者核查这类设备的性能。其主要适用于理疗师、医学从业人员、脊椎按摩师、正骨医师、美容师、队医、生物医学工程师、医学物理师、医疗器械维护人员、商业测试人员、检验机构或制造商等。 注：本标准中涉及资料性的所有公开出版物的名称列于参考文献。

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

YY 0789-2010 Q开关Nd：YAG激光眼科治疗机

本标准规定了 Q开关Nd:YAG激光眼科治疗机的基本参数和产品组成、技术要求、试验方法以及标志标签、包装等要求。 本标准适用于Q开关Nd:YAG激光眼科治疗机（以下简称治疗机）。治疗机通过波长为1064nm 激光脉冲对人体组织的光解/光致爆破作用，用于眼前节组织的切开和切除术，以达到治疗目的。

Q-Switched Nd:YAG laser ophthalmic system

YY 0773-2010 眼科B型超声诊断仪通用技术条件

本标准规定了眼科B型超声诊断仪的组成与基本参数、要求、试验方法、标志和使用说明书。 本标准适用于超声工作频率范围10MHz～25MHz的眼科B型超声诊断仪（以下简称诊断仪）。

General technical requirements for ophthalmic ultrasound B-mode scan

YY/T 0773-2010 眼科B型超声诊断仪通用技术条件

General technical requirements for ophthalmic ultrasound B-mode scan

BS EN 60601-2-33:2010+A11:2011 医用电气设备.医疗诊断用磁共振设备基本安全性和必要性能的详细要求

Medical electrical equipment. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

BS EN 60601-2-33:2010 医用电气设备.医疗诊断用磁共振设备的基本安全性和必要性能的详细要求

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT. This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE. 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. The standard does not formulate ESSENTIAL PERFORMANCE requirements related to INTERVENTIONAL MR EXAMINATIONS.

Medical electrical equipment. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

IEC 62359:2010 声学.声场特性.与医疗诊断超声场有关的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 exposure 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.

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

DIN EN 61391-2:2010 超声波学.脉冲回波扫描仪.第2部分:最大渗透深度和局部动态范围的测定(IEC 61391-2-2010).德文版本EN 61391-2-2010

Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range (IEC 61391-2:2010); German version EN 61391-2:2010

BS EN ISO 11990-2:2010 激光器和相关的激光设备.气管导管抗激光性的测定.气管导管袖带

This part of ISO 11990 specifies a method of testing the continuous wave (cw) resistance of the cuff regions of tracheal tubes designed to resist ignition by a laser. Other components of the system, such as the inflation system and shaft (as defined in ISO 11990-1), are outside the scope of this part of ISO 11990. NOTE 1 The method for testing the laser resistance of the tracheal tube shaft is in the scope of ISO 11990-1. The specified test method can be used to measure and describe the properties of materials, products or assemblies in response to heat and flame under controlled laboratory conditions. It does not describe or appraise the fire hazard or fire risk of materials, products or assemblies under actual clinical use conditions. However, the results of this test method may be used as an element of a fire risk assessment which takes into account all of the factors that are pertinent to an assessment of the hazard of a particular end use. NOTE 2 Caution should be observed in interpreting these results, since the direct applicability of the results of this test method to the clinical situation has not been fully established. NOTE 3 This test method might involve hazardous materials, operations and equipment. This part of ISO 11990 provides advice on minimizing some of the risks associated with its use but does not purport to address all such risks. It is the responsibility of the user of this test method to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Lasers and laser-related equipment. Determination of laser resistance of tracheal tubes. Part 2: Tracheal tube cuffs

IEC TR 62649:2010 高强度超声波治疗设备(HITU)的测量标准要求

This technical report is relevant to the measurement and specification of ultrasound fields intended for medical therapeutic purposes. Lithotripsy and physiotherapy are excluded, since there are existing International Standards for these applications. It establishes: ? topics where there is a consensus that the development of International Standards would benefit the industries and/or patients; ? topics where the writing of standards should start immediately; ? topics where the writing of technical specifications should start immediately in order to gain practical experience and establish consensus prior to standardisation; ? topics which require future standardisation but where further research is required before initiating the writing of standards or technical specifications. This report addresses primarily the requirements for measurement standards related to high intensity therapeutic ultrasound (HITU) [also known as high intensity focused ultrasound (HIFU)] fields which are both high intensity and focused and where the main mechanism for action is thermal. However, aspects of the discussion, conclusions and any resulting standards or technical specifications may also be relevant to therapeutic applications which are either focused or high intensity or where the main mechanism is not thermal. Scientific literature has been reviewed and responses to a questionnaire which was sent to experts around the world are reported.

Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices

DIN CLC/TS 61949:2010 超声学.原位表征.有限振幅超声波束原位曝光评估

This Technical Specification spezifies and describs the general concepts of the limits of applicability of acoustic measurements in water, a method to ensure that measurements are made under quasi-linear conditions, to acoustic fields in the frequency range 0.5 MHz to 15 MHz to both circular and rectangular source geometries and both contiuous-wave and pulsed fields. It also spezifies the definition of an acoustic quantity appropriate for establishing quasi-linear conditions, a threshold value for the acoustic quantity as an upper limit for quasi-linear conditions and a method for the estimation of attenuated acoustic quantities under conditions of nonlinear propagation in water.

Ultrasonics - Field characterization - In situ exposure estimation in finite-amplitude ultrasonic beams (IEC/TS 61949:2007); German version CLC/TS 61949:2008

SANS 60601-2-50:2010 医用电气设备．第2-50部分:婴儿光线疗法设备的基本安全和基础性能的详细要求

Applies to the basic safety and essential performance of infant phototherapy equipment.

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

IEC 61391-2:2010 超声波学.脉冲回波扫描仪.第2部分:最大渗透深度和局部动态范围的测定

This part of IEC 61391 defines terms and specifies methods for measuring the maximum depth of penetration and the local dynamic range of real-time ultrasound B-MODE scanners. The types of transducers used with these scanners include: ?C mechanical probes; ?C electronic phased arrays; ?C linear arrays; ?C curved arrays; ?C two-dimensional arrays; ?C three-dimensional scanning probes based on a combination of the above types. All scanners considered are based on pulse-echo techniques. The test methodology is applicable for transducers operating in the 1 MHz to 15 MHz frequency range operating both in fundamental mode and in harmonic modes that extend to 15 MHz. However@ testing of harmonic modes above 15 MHz is not covered by this standard. NOTE Phantom manufacturers are encouraged to extend the frequency range to which phantoms are specified to enable tests of systems operating at fundamental and harmonic frequencies above 15 MHz.

Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range

YY 0322-2009 高频电灼治疗仪

本标准规定了高频电灼治疗仪的术语、要求、试验方法、检验规则、标志、包装、运输及贮存。 本标准适用于输出功率在50W以内的，采用无中性电极的单手术电极的高频电灼治疗仪。

High frequency fulguration therapy equipment