C41 医用超声、激光、高频仪器设备 标准查询与下载

NF S97-132-2:2009 激光和激光相关设备.手术布单和/或病人保护覆盖物耐激光性的试验方法和分类.第2部分:二次点火

Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2 : secondary ignition.

IEC 60601-2-5:2009 医用电气设备.第2-5部分:超声波理疗设备基本安全性和必要性能的详细要求

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:?C EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry);?C EQUIPMENT in which focused ULTRASOUND pulse waves are used to destroy conglomerates such as stones in the kidneys or the bladder (lithotrites) (for information refer to IEC 60601-2-36);?C ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ULTRASOUND pulse waves are used.

Medical electrical equipment - Part 2-5: Particular requirements for basic safety and essential performance of ultrasonic physiotherapy equipment

SANS 60601-2-2:2009 医用电气设备.第2-2部分:对高频手术设备及高频手术附件的基本安全及基本性能的特殊要求

Applies to the basic safety and essential performance of high frequency surgical equipment.

Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

DIN EN 61157 Berichtigung 1:2009 医疗诊断超声波设备声输出的报告用标准方法.技术勘误DIN EN 61157-2008-07

Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (IEC 61157:2007); German version EN 61157:2007, Corrigendum to DIN EN 61157:2008-07

KS C IEC 60601-2-39:2008 医用电气设备.第2-39部分:腹膜透析仪基本安全和基本性能的特殊要求

이 표준은 다음 항목 외에는 KS C IEC 60601-1의 1.을 적용한다.추가:

Peritoneal dialysis equipment

KS C IEC 60601-2-36:2008 医用电气设备.第2-36部分:体外碎石机安全性特殊要求

추가:이 표준은 2.2.101에 정의된 체외형 쇄석기 기기 안전성에 적용한다.이

Extracorporeally induced lithotripsy

KS C IEC 60601-2-38:2008 医用电气设备.第2-38部分:医院电动床安全性特殊要求

KS C IEC 60601-1의 1.1에 따르는 외에 다음 사항을 따른다.이 표준은

Hospital beds

IEC 87/402/CD:2008 IEC/TS 62558：超声波实时脉冲回波扫描仪 使用空隙对信噪比的 3-D 分布进行自动评估和定期测试的体模和方法

IEC/TS 62558: Ultrasonics-real-time pulse-echo scanners - Phantom and method for automated evaluation and periodic testing of 3-D distributions of signal-to-noise ratio using voids

YY/T 0324-2008 红外乳腺检查仪

Infrared Breast Scanner

YY/T 0705-2008 超声连续波多普勒系统试验方法

本标准规定了： 用于测量连续波超声多普勒流量计、流速计或胎心率检测仪性能的测试方法； 用于测定多普勒超声系统各项性能参数的专用多普勒试件。 本标准适用于： 对整个多普勒超声系统整机，即对未拆解或未断开连接的系统进行测试； 对连续波多普勒超声系统进行的测试。 在本标准中，不包含有关电气安全和声输出的内容。

Ultrasonics.Continuous-wave Doppler systems.Test procedures

YY 0299-2008 医用超声耦合剂

本标准规定了医用超声藕合剂的定义、要求、试验方法、检验规则及其包装、标志、运输和贮存。 本标准适用于医用超声藕合剂产品(以下简称产品)，包括企业作为商品制造、销售的，也包括医疗单位自制自用的。该产品在超声诊断和治疗操作中用作探头(或治疗头)与皮肤之间的透声媒质。 本标准可供医用超声藕合垫参考采用。 本标准不适用于术中超声操作中与组织切口直接接触的产品。对具有其他特性(如无菌、灭菌)的产品，制造商应补充其相应要求。

Medical ultrasonic couplant

YY/T 0704-2008 超声脉冲多普勒诊断系统性能试验方法

本标准规定了： 测量脉冲多普勒超声系统性能的试验方法； 用于进行这些试验的多普勒测试件。 本标准适用于： 对脉冲多普勒超声系统整机的试验，该系统未被拆解成子系统或断开相互间的连接； 对脉冲多普勒超声系统的试验，该系统可以是独立的，或作为其他超声仪器的一部分。 本标准不涉及电安全、声安全和电磁兼容性(EMC)的内容。

Ultrasonics-Pulsed Doppler diagnostic system-Test procedures to determine performance

YY/T 0703-2008 超声实时脉冲回波系统性能试验方法

本标准规定了0.5MHz至15MHz频率范围内，医用实时超声成像设备的性能试验方法。 本标准适用于下列各类采用脉冲回波原理的实时超声扫描仪： 机械扇形扫描仪； 电子相控阵扇形扫描仪； 电子线阵扫描仪； 电子凸阵扫描仪； 基于上述四种扫描方式中任何一种的水浴式扫描仪。

Ultrasonics.Real-time pulse-echo systems.Test procedures to determine performance specifications

IEC 61157:2007/COR1:2008 医疗诊断超声设备声输出报告的标准方法（2.0 版）

This International Standard is applicable to medical diagnostic ultrasonic equipment.It establishes requirements for the declaration of the acoustic output information:- to be presented in technical data sheets supplied to prospective purchasers of equipment by manufacturers;- to be declared in the accompanying literature/manual supplied by manufacturers;- as background information to be made available on request to interested parties by manufacturers.It also gives exemption conditions for equipment generating low acoustic output levels.

Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (Edition 2.0)

BS EN 60601-2-37:2008+A11:2011 医疗电气设备.超声波医疗诊断和监测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 ultrasonic medical diagnostic and monitoring equipment

BS EN 60601-2-37:2008 医疗电气设备.超声波医疗诊断和监测设备基本安全和重要性能的特殊要求

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

DIN EN 61157:2008 医疗诊断超声波设备的声输出报告用标准方法

Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (IEC 61157:2007); German version EN 61157:2007

DIN EN 61689:2008 超声波学.物理疗法设备.频率范围为0.5MHz～5MHz的超声波场规范和测量方法

Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz (IEC 61689:2007); German version EN 61689:2007

BS EN 62127-1:2007 超声学.水听器.第1部分:医疗超声波场频率小于40MHz的测量和特性

This part of IEC 62127 specifies methods of use of calibrated hydrophones for the measurement in liquids of acoustic fields generated by ultrasonic medical equipment operating in the frequency range up to 40 MHz. The objectives of this standard are: – to define a group of acoustic parameters that can be measured on a physically sound basis; – to define a second group of parameters that can be derived under certain assumptions from these measurements, and called derived intensity parameters; – to define a measurement procedure that may be used for the determination of acoustic pressure parameters; – to define the conditions under which the measurements of acoustic parameters can be made in the frequency range up to 40 MHz using calibrated hydrophones; – to define procedures for correcting, for limitations caused by the use of hydrophones with finite bandwidth and finite active element size. NOTE 1 Throughout this standard, SI units are used. In the specification of certain parameters, such as beam areas and intensities, it may be convenient to use decimal multiples or submultiples. For example beam area may be specified in cm2 and intensities in W/cm2 or mW/cm2. NOTE 2 The hydrophone as defined may be of a piezoelectric or an optic type. The introduction however implies that optical hydrophones are not covered.

Ultrasonics — Hydrophones — Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz

BS EN 62127-3:2007 超音波学.水听器.第3部分:超音波场小于40MHz的水听器性能

This part of IEC 62127 specifies relevant hydrophone characteristics. This standard is applicable to: – hydrophones employing piezoelectric sensor elements, designed to measure the pulsed and continuous wave ultrasonic fields generated by ultrasonic equipment; – hydrophones used for measurements made in water; – hydrophones with or without an associated pre-amplifier.

Ultrasonics — Hydrophones — Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz