C41 医用超声、激光、高频仪器设备 标准查询与下载

BS EN 61847:1998 超声波 手术系统 基本输出特性的测量和声明

Specifies essential non-thermal output characteristics, including those to be declared by the manufacturer, and their methods of measurement for ultrasonic surgical units.

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

IEC 61846:1998 超音波学.压力脉冲碎石器.声场特性

This International Standard is applicable to - lithotripsy equipment using extracorporeally induced pressure waves; - lithotripsy equipment producing focused mechanical energy. This International Standard does not apply to percutaneous and laser lithotripsy equipment. This International Standard specifies - measurable parameters which could be used in the declaration of the acoustic output of extracorporeal lithotripsy equipment, - methods of measurement and characterization of the pressure field generated by lithotripsy equipment. NOTE - The parameters defined in this International Standard do not - at the present time - allow quantitative statements to be made about effectiveness and possible hazard. In particular, it is not possible to make a statement about the limits for these effects. While this particular standard has been developed for equipment intended for use in lithotripsy, it has been developed such that, as long as no other specific standards are available to be used for other medical applications of therapeutic extracorporeal pressure pulse equipment, this standard may be used as a guideline.

Ultrasonics - Pressure pulse lithotripters - Characteristics of fields

JIS T 1453:1998 高频外科手术设备

High frequency surgical equipment

CSA IEC-1288-2-98-CAN/CSA:1998 心脏除颤器-心脏除颤器-监测器-第2部分:维护.第1版.CEI/IEC 1288-2:1993

This International Standard specifies requirements for classification of wire electrodes in the as-welded condition and in the post weld heat-treated condition for gas shielded metal arc welding of non alloy and fine grain steels with a minimum yield st

Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 2: Maintenance First Edition; CEI/IEC 1288-2: 1993

CSA IEC-1288-1-98-CAN/CSA:1998 心脏除颤器-心脏除颤器-监测器-第1部分:操作.第1版.CEI/IEC 1288-1:1993

Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 1: Operation First Edition; CEI/IEC 1288-1: 1993

Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 1: Operation First Edition; CEI/IEC 1288-1: 1993

IEC 61847:1998 超声学 外科装置 基本输出特性的测量和标示

This International Standard specifies: - the essential non-thermal output characteristics of ultrasonic surgical units; NOTE 1 - One of the parameters of interest is output acoustic power. This standard addresses only the low-frequency (under 100 kHz) component of the total delivered energy. The high-frequency component, which probably relates to cavitation developed at the tip, is not addressed (see A.4). - methods of measurement of these output characteristics; - those characteristics which should be declared by the manufacturers of such equipment. NOTE 2 - In the interest of clarity, this standard does not address all of the complex surfaces and shapes possible for applicator tips. A straight tubular shape is used in the description of the parameters and measurements to be made. It is left to the user of this standard to adapt the basic methodology described to more complex designs if required. This International Standard is applicable to equipment which meets the requirements of a, b and c below: a) ultrasonic surgical systems operating in the frequency range 20 kHz to 60 kHz; and b) ultrasonic surgical systems, whose use is the fragmentation or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and c) ultrasonic surgical systems, in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site. NOTE 3 - Examples of these types of systems are surgical aspirators, intracorporeal lithotripters, end-cutting devices etc. This International Standard is not applicable to: - lithotripsy equipment which uses extracorporeally induced pressure pulses, focussed through liquid conducting media and the soft tissues of the body; - surgical devices used as part of the therapeutic process (hyperthermia systems); - surgical devices whose acoustic application areas are not at the end of a longitudinally vibrating applicator tip and therefore would not fit the monopole model used in this standard. This International Standard does not deal with the effectiveness or safety of ultrasonic surgical systems. NOTE 4 - Throughout this standard, the term accuracy means the overall uncertainty expressed at the 95 % confidence level.

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

BS 7887:1997 超声波学.实时脉冲回波系统.测定性能规范的试验程序指南

This technical report describes methods of measuring the performance of real-time medical ultrasonic imaging equipment in the frequency range 0,5 MHz to 15 MHz. This report is relevant for real-time ultrasonic scanners based on the pulse-echo principle, for the types listed below: - mechanical sector scanner; - electronic phased array sector scanner; - electronic linear array scanner; - electronic curved array sector scanner; - water-bath scanner based on any of the above four scanning mechanisms.

Ultrasonics - Real-time pulse-echo systems - Guide for test procedures to determine performance specifications

IEC 60601-2-36:1997 医用电气设备 第2-36部分:体外碎石机安全专用要求

Addition: This Particular Standard applies to the safety of EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 2.1.101. The applicability of this Particular Standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging and monitoring devices. Other devices, such as PATIENT treatment planning computers, X-ray and ultrasonic devices, are excluded from this Standard, because they are treated in other applicable IEC standards. While this Particular Standard has been developed for EQUIPMENT intended for use in LITHOTRIPSY, it has been developed such that, as long as no other specific standards are available to be used for other medical applications of therapeutic extracorporeal PRESSURE PULSE equipment, this Standard may be used as a guideline.

Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy

IEC 61689:1996 超声学 理疗装置 0.5MHz～5MHz频率范围内的性能要求和测量方法

Applies to ultrasonic equipment designed for physiotherapy consisting of an ultrasonic transducer generating ultrasonic energy in the frequency range 0,5 MHz to 5 MHz. Replaces IEC 150, published in 1963.

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

BS EN 60601-2-22:1996 医疗电气设备.安全性详细要求.激光诊断和治疗设备规范

Safety of laser equipment for medical applications classified as a Class 3B or Class 4 laser product.

Medical electrical equipment - Particular requirements for safety - Specification for diagnostic and therapeutic laser equipment

DIN EN 61266:1996 超声波.手持传感式多普勒胎儿心跳探测仪.性能要求及测量和报告方法

The document establishes methods of measurement of performance of a complete ultrasonic hand-held doppler foetal heartbeat detector, requirements for the performance of equipment, requirements for the reporting of the performance of existing equipment and requirements for the declaration by manufacturers in accompanying literature of aspects of the performance of equipment.

Ultrasonics - Hand-held probe doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting (IEC 61266:1994); German version EN 61266:1995

NF C97-907:1995 超声场.使用频率范围在0.5MHz至15MHz 水下听音器的医疗超声设备所产生的超声场的测量和特性化指南

Ultrasonics fields. Guidance for the measurement and characterization of ultrasonic fields generate by medical ultrasonic equipment using hydrophones in the frequency range 0,5 MHz to 15 MHz.

ASTM F1628-95(2000) 激光外科学用套箍和未套箍气管导管及有关治疗的标记和标志的标准规范

1.1 This specification covers the labeling, marking, warnings, and precautions for cuffed and uncuffed tracheal tubes and related materials intended by the manufacturer for use during laser surgery of the airway. 1.2 Rationale for this specification is to provide a standard format for reporting results obtained from Test Method F1497. Safety and performance tests, with availability of results, are described in this specification to allow a manufacturer the maximum use of technological alternatives in design and materials. This specification addresses the laser resistance of the shaft of the tracheal tubes. Other components of the system, such as the inflation system and cuff, are outside the scope of this specification. 1.3 The values stated in SI units are to be regarded as standard.

Standard Specification for Labeling and Marking of Cuffed and Uncuffed Tracheal Tubes and Related Treatments Intended for Use During Laser Surgery

NF C97-904:1994 医疗诊断超声波设备的声输出申报的要求

Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment.

IEC 61266:1994 超声学 手持探头式多普勒胎儿心音检测仪 性能要求及测量和报告方法

Establishes methods of measurement of performance of a complete detector, requirements for the reporting of the performance of existing equipment, requirements for the declaration by manfacturer in accompanying literature of aspects of the performance of

Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting

IEC TR3 61289-2:1994 高频外科设备 第2部分:维护

Contains guidelines regarding the maintenance on high frequency surgical equipment, as defined in clause 3, to be performed by clinical engineering personnel. The application guidelines deal with the maintenance of high frequency surgical equipment const

High frequency surgical equipment - Part 2: Maintenance

IEC TR3 61289-1:1994 高频外科设备 第1部分:操作

Contains guidelines regarding the safe and effective operation and maintenance on high frequency surgical equipment, constructed according to the safety requirements of IEC 601-1 and IEC 601-2-2, to be performed by medical and nursing personnel.

High frequency surgical equipment - Part 1: Operation

YY/T 0163-1994 医用超声测量水听器特性和校准

1.1 本标准规定了0.5～10 MHz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主要性能参数、技术要求和校准方法。 1.2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成。

Hydrophone Characterization and Calibration for Medical Ultrasonic Measurements

YY/T 0162.1-1994 医用超声设备档次系列.第一部分:B型超声诊断设备

本标准规定了国产B型超声诊断设备档次划分的方法和各档次设备的性能指标及功能要求。 本标准适用于标称频率不超过7.5 MHz范围内的B型超声诊断设备，作为此范围内B型超声诊断设备划分档次的依据。

Class series of medical ultrasonic equipment Part 1: B mode ultrasonic diagnostic equipments

YY 0016-1993 低频电子脉冲治疗仪

本标准规定了低频电子脉冲治疗仪的技术要求、试验方法、检验规则、标志、包装、运输、贮存等内容。 本标准适用于以低频电子脉冲或直流电形式直接通过毫针或皮肤电极剃激人体穴位进行治疗和保健的仪器。

Low Frequency Electronic Pulse Therapy Apparatus