C41 医用超声、激光、高频仪器设备 标准查询与下载

YY/T 1090-2004 超声理疗设备

本标准规定了超声理疗设备的术语和定义、要求、试验方法、检验规则及标志、包装。 本标准适用于频率范围0.5 MHz至5MHz、由平面圆形超声换能器产生连续波或准连续波超声能量的超声理疗设备，本标准不适用于有效声强大于3W/cm2以上或采用聚焦超声波的设备。

Ultrasonic physiotherapy system

IEC 60601-2-37:2004 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

Establishes particular requirements for the safety of ultrasonic diagnostic equipment and those aspects thereof which are directly related to safety. Does not cover ultrasonic therapeutic equipment; however, equipment used for the imaging of body structu

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

YY 0307-2004 连续波掺钕钇铝石榴石激光治疗机 通用技术条件

本标准规定了连续波掺钕钇铝石榴石激光治疗机通用技术条件的定义、分类、要求、试验方法、抽祥和标志、标签、包装等要求。 本标准适用于波长为1.064μm的连续波掺钕钇铝石榴石激光治疗机。该仪器主要用于患者的治疗。

General specification of Nd:YAG laser medical instrument with continuous wave (CW)

YY 0284-2004 氦氖激光血管内照射治疗仪 通用技术条件

本标准规定了氦氖激光血管内照射治疗仪的定义、分类、要求、试验方法、抽样和标志、标签、包装等要求。 本标准适用于波长为632.8nm的连续波、低功率氦氖激光内照仪。该仪器用于血管内对循环血液进行激光照射治疗。具有血管内照射功能的氦氖激光多功能照射仪也应参照使用本标准。 对于其他光源的内照仪，在没有专用标准的情况下，本标准可作为其安全要求的一个适用的导则，但不包括该仪器的特殊要求。

The general specification of He-Ne laser medical instrument for ILIB

YY 0109-2003 医用超声雾化器

本标准规定了医用超声雾化器的分类、要求、试验方法、检验规则以及标志、使用说明书。 本标准适用于利用超声波对液态药物进行雾化的超声雾化器，该产品主要供吸入治疗，也可用于医疗环境的空气加湿。

Medical ultrasonic nebulizer

YY/T 0458-2003 超声多普勒仿血流体模的技术要求

本标准规定了超声多普勒仿血流体模的主要技术要求与测量方法。 本标准适用于由超声仿组织材料、稳态流动的仿血液及其所流经管道构成的超声多普勒仿血流体模，该装置主要用于检测和评价超声多普勒血流诊断设备的性能。

Technical requirements for ultrasonically blood-mimicking Doppler phantom

YY 0460-2003 超声洁牙设备

本标准规定了超声洁牙设备的术语和定义、符号、要求、试验方法、检验规则及标志、随行文件。 本标准适用于在18kHz至60kHz频率范围内、由超声换能器产生连续或准连续波超声能量的超声洁牙设备。

Ultrasonics dental descaler equipment

YY/T 1142-2003 医用超声诊断和监护设备.频率特性的测试方法

 本标准规定了频率范围在0.5MHz～15MHz内的超声诊断和监护设备频率特性的测量方法。 本标准适用于工作在连续波、准连续波或脉冲波状态的各类超声诊断设备和超声监护设备，这些设备可以配用单晶片发-收型探头、双单晶片发-收分开型探头，多晶片梅花型探头、机械扇扫探头、线性探头、凸阵探头及相控阵探头等。

Methods of measuring the frequency of medical diagnostic and monitoring ultrasonic equipment

CSA C22.2 No.60601-2-37-03-2003(R2007) 医疗电气设备.第2-37部分:医用超声诊断和监护设备安全性的详细要求

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

YY 0448-2003 超声多普勒胎儿心率仪

本标准规定了超声多普勒胎儿心率仪(也称"胎心音仪"、"胎儿听诊器")的术语和定义、要求、试验方法、检验规则以及标志和使用说明书。 本标准适用于根据多普勒原理从孕妇腹部获取胎儿心脏运动信息的超声多普勒胎儿心率检测仪。

Ultrasonic Doppler foetal heartbeat detector

YY 0449-2003 超声多普勒胎儿监护仪

本标准规定了超声多普勒胎儿监护仪的术语和定义、要求、试验方法、检验规则以及标志和使用说明书。 本标准适用于超声多普勒胎儿监护仪，该产品采用连续波或脉冲波超声多普勒原理，在围产期对胎儿进行连续监护，并在出现异常时及时提供报警信息。

Ultrasonic Doppler foetal monitor

BS EN 60601-2-33:2002+A2:2008 医用电气设备.第2-33部分:医疗诊断用磁共振设备的安全性详细要求

This Particular Standard applies to MAGNETIC RESONANCE EQUIPMENT as defined in 2.2.101 and MAGNETIC RESONANCE SYSTEMS as defined in 2.2.102. This Standard does not cover the application of MAGNETIC RESONANCE EQUIPMENT beyond the INTENDED USE.

Medical electrical equipment -Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

BS EN 60601-2-37:2001 医用电气设备.第2-37部分:超声波医疗诊断和监测设备的特殊安全要求

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

CSA C22.2 No.60601-2-5-02-2002 电子医疗设备 第2-5部分：物理治疗用超声设备的特殊安全规则第二版

L’Association canadienne de normalisation (CSA), sous les auspices de laquelle cette Norme nationale a été préparée, a re?u ses lettres patentes en 1919 et son accréditation au sein du Système de Normes nationales par le Conseil canadien des normes en

Electromedical devices - Part 2-5: Special safety rules for ultrasound devices for physiotherapy Second Edition

YY 0322-2000 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极高频电灼仪。

High frequency electrocautery therapy equipment

BS IEC 60825-8:2000 激光产品的安全.医疗激光设备安全使用指南

Safety of laser products - Guidelines for the safe use of medical laser equipment

DIN EN 61846:1999 超声波.压力脉冲碎石器.电磁场特性

Extracorporeal lithotripsy is widely used for the clinical treatment of renal and uretic stones. Lithotripsy employs high intensity acoustic waves to produce disintegration of the stones through a process of sequential application of pressure waves. Several different forms of lithotripsy equipment are now commercially available from a number of manufacurers. The document specifies methods of measuring and characterising the acoustic pressure filed generated by lithotripsy equipment.

Ultrasonics - Pressure pulse lithotripters - Characteristics of fields (IEC 61846:1998); German version EN 61846:1998

BS EN 61846:1999 超声波 压力脉冲碎石机 领域特点

Specifies methods of measurement and characterization of the pressure field generated and measurable parameters for the declaration of acoustic output for extracorporeal equipment. This standard is not applicable for laser and percutaneous lithotripsy equipment.

Ultrasonics. Pressure pulse lithotripters. Characteristics of fields

ASTM F1497-99a 导管轴耐激光性能测定的标准试验方法

This test method determines a uniform and repeatable measurement of the laser resistance of the shaft of a tracheal tube. Most of the variables involved in laser ignition of a tracheal tube have been fixed in order to establish a basis for comparison. This measurement can be used to compare tracheal tubes having differing designs of laser protection. There are a large number and range of variables involved in laser ignition of a tracheal tube. A change in one variable may affect the outcome of the test. Caution should be observed since the direct applicability of the results of this test method to the clinical situation has not been fully established. Since it is conceivable that an oxygen enriched atmosphere may be encountered in the clinical situation, either intentionally or unintentionally, the test is performed in an environment of 98 (±2 %) oxygen. A flow rate of 1 L/min in a 6.0-mm inner diameter tube was chosen as the best condition for tube ignition and establishment of a fire. Opportunities for Development8212;Variations of this test method can be applied to study the effect of changing the test conditions but are outside the scope of this test method. For example, variation of the respiratory gas flow rate or different breathing gas mixtures may affect the laser resistance of the tracheal tube. Use of modes of laser energy delivery other than continuous, (for example, pulsed, superpulse, q-switched, and ultrapulsed), may alter the tracheal tubersquo;ignition characteristics. Also, tubes of different diameter will have laser resistance different from that defined in this test method.1.1 This test method covers a standard means of testing the laser resistance of the shaft of a tracheal tube. 1.2 This test method addresses the laser resistance of the shaft of the tracheal tube. Other components of the system, such as the inflation system and cuff, are outside the scope of this test method. 1.3 Caution should be observed since the direct applicability of the results of this test method to the clinical situation has not been fully established. 1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 1.5 This test method should be used to measure and describe the properties of materials, products, or assemblies in response to heat and flame under controlled laboratory conditions and should not be used to describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual fire conditions. However, results of this test may be used as elements of a fire risk assessment that takes into account all of the factors that are pertinent to an assessment of the fire hazard of a particular end use. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific precautionary statements are given in Notes 1 through 6.

Standard Test Method for Determining Laser Resistance of the Shaft of Tracheal Tubes

DIN EN 61847:1998 超声波.外科装置.基本输出特性的测量和说明

The document defines the parameters which characterize the output and performance of open and closed site ultrasonic surgical systems, and indicates which parameters should be declared. In addition, measurement procedures are described so that technicaly qualified people will be able to report on the parameters in a uniform and understandable fashion.

Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics (IEC 61847:1998); German version EN 61847:1998