11.040.55 诊断设备 标准查询与下载

IEC 60601-2-33:2008 医用电气设备.第2-33部分:医疗诊断用磁共振设备安全性的特殊要求

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

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

JJG 270-2008 血压计和血压表检定规程

本规程适用于（台式和立式）水银血压计（以下简称血压计）和弹性式血压表（以下简称血压表）的首次检定、后续检定和使用中检验。

Verification Regulation of Sphygmomanometer

DS/EN 61157:2008 医疗诊断超声设备声输出报告的标准方法

Establishes requirements for the declaration of the acoustic output information: 1.to be presented in technical data sheets supplied to prospective purchasers of equipment by manufacturers; 2.to be declared in the accompanying literature/ manual supplied by manufacturers; 3.as background information to be made available on request to interested parties by manufacturers.

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

NF C97-909:2008 超声波学.物理治疗系统.频率范围0.5MHz～5MHz的范围规范和测量方法

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

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

DIN EN 60601-1-8:2008 医用电气设备.第1-8部分:基本安全和基本性能通用要求.汇编标准:医疗电气设备和医疗电气系统中警报系统的一般要求、试验和指南

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC

EN 60601-2-37:2008 医用电气设备.第2-37部分:医用超声诊断和监护设备基本安全和主要性能的特殊要求

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 (Incorporates Amendment A1: 2015)

GOST R 52921-2008 医疗最大玻璃温度计.通用规范

Medical maximum glass thermometers. General specifitications

GOST R IEC 61157-2008 国家测量统一性保证体系.医疗电气装置.超声波诊断装置.技术文档中声音输出参数表述的要求

State system for ensuring the uniformity of measurements. Medical electrical equipment. Devices for ultrasonic diagnostics. Requirements for the declaration of acoustic output parameters in technical documents

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

BS EN ISO 81060-1:2012 非侵入式血压计.非自动测量式血压计的要求和试验方法

Non-invasive sphygmomanometers. Requirements and test methods for non-automated measurement type

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 60601-1-8:2007+A1:2013 医用电气设备.基本安全性和基本性能的通用要求.附属标准:医疗电气设备和医疗电气系统中警报系统的通用要求、试验和导则

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

KS C IEC 60601-2-34:2007 医疗电气设备.第2-34部分:侵入式血压监测仪器安全性(包括基本性能)的特殊要求

이 규격은 2.101에 정의된 관혈식 혈압 감시 기기의 안전에 관한 요구사항에 대하여 규정

Medical electrical equipment－Part 2－34：Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

IEC 60601-2-33/AMD2:2007 医用电气设备.第2-33部分:医疗诊断用磁共振设备安全的特殊要求.修改件2

This standard is Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis; Amendment 2.

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

DS/IEC/TS 62306:2007 超声学 场特性 用于确定诊断超声场中温度升高的测试对象

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 ensure that the performance specifications are achieved;- validation procedures;- general test methods for using test objects to determine standardised temperature rises.

Ultrasonics - Field characterisation - Test objects for determining temperature elevation in diagnostic ultrasound fields

DIN EN 60601-2-27 Berichtigung 1:2007 医用电气设备.第2-27部分:包括心电图仪监测设备基本性能的安全性专用要求

Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27:2005); German version EN 60601-2-27:2006, Corrigenda to DIN EN 60601-2-27 (VDE

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

CAN/CSA-Z7376-2007 麻醉和呼吸设备 气管插管喉镜

This National Standard of Canada is based on International Standard ISO 7376:2003. 1 Scope This International Standard specifies general requirements for laryngoscopes and critical dimensions for the handle and lamp of hook-on type laryngoscopes. It is applicable only to instruments with an electrical power source for illuminating the larynx, since electrical safety requirements may be more stringent for instruments connected to mains or external power packs. This International Standard is not applicable to surgical instruments known by the same generic name. This International Standard does not apply to: a) the blade form or handle design, except for general requirements and the interchangeability aspects of the connection between the blade and the handle; b) the measurement and specification of the lamp illumination intensity; c) flexible laryngoscopes, or laryngoscopes designed for surgery; d) laryngoscopes powered from mains electricity supply; e) laryngoscopes connected by light-transmitting cables to external light sources. NOTE Instruments connected by light guides to an external light source may be subject to other International Standards for endoscopes.

Anaesthetic and Respiratory Equipment - Laryngoscopes for Tracheal Intubation