11.040.55 诊断设备 标准查询与下载

CAN/CSA-C22.2 No.60601-2-37-2008(C2019) 医用电气设备 第2-37部分：医用超声诊断和监测设备基本安全和基本性能的特殊要求

La présente norme nationale du Canada est équivalente a la norme internationale IEC 60601-2-37:2007. Domaine d'application Addition: La présente Norme Internationale s'applique à la SÉCURITÉ DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE DIAGNOSTIC À ULTRASONS comme définis en 201.3.217, désignés ci-après sous le terme APPAREILS EM. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTÈMES EM, le titre et le contenu de cet article ou de ce paragraphe l'indique. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTÈMES EM, selon le cas. Les DANGERS inhérents à la fonction physiologique prévue de L'APPAREIL EM ou du SYSTÈME EM dans le cadre du domaine d'application de la présente norme ne sont pas couverts par des exigences spécifiques contenues dans la présente norme, à l'exception de 7.2.13 et de 8.4.1 de la présente norme. NOTE Voir également le paragraphe 4.2 de la présente norme. La présente norme particulière ne couvre pas les appareils thérapeutiques à ultrasons. Les appareils utilisés pour réaliser l'imagerie ou le diagnostic de structures du corps par ultrasons, en association avec une autre procédure médicale, sont couverts.

Medical electrical devices - Part 2-37: Particular requirements for basic safety and essential performance of medical ultrasound diagnostic and monitoring devices

JIS T 3323:2008 压力传感器

Pressure transducers

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 0668-2008 医用电气设备.第2-49部分：多参数患者监护设备安全专用要求

本专用标准适用于2.2.101定义的多参数患者监护设备的安全要求。 本标准的范围限于有一个以上的应用部分或多于一个单项功能，且连接到单一患者的设备。本标准未对单独的监护功能做规定。

Medical electrical equipment-Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment

YY/T 0068.3-2008 医用内窥镜　硬性内窥镜　第3部分：标签和随附资料

Medical endoscopes—Rigid endoscope—Part 3:Marking and instruction manual

IEC 80601-2-59:2008 医用电气设备 第 2-59 部分：用于人体发热体温筛查的筛查温度记录仪的基本安全和基本性能的特殊要求

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of humans under indoor environmental conditions@ hereafter referred to as ME EQUIPMENT. This International Standard sets laboratory characterization test limits for the SCREENING THERMOGRAPH. NOTE A SCREENING THERMOGRAPH is intended for screening and detection of human subjects with SKIN TEMPERATURES elevated above normal. An elevated SKIN TEMPERATURE needs to be followed up by a subsequent temperature measurement using a clinical thermometer (see IEC 80601-2-56). 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.

Medical electrical equipment - Part 2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening

KS C IEC 60601-2-51-2008 医用电气设备零件 如权利要求2-51:单和多通道ECG记录和安全和基本性能的分析

Medical electrical equipment－Part 2－51：Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

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

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

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

DS/EN 60601-2-37:2008 医用电气设备 第2-37部分：超声医疗诊断和监护设备基本安全和基本性能的特殊要求

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 an

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

JJG 543-2008 心电图机检定规程

本规程适用于实时测量人体表面心脏电位的模拟单通道、多通道心电图机的首次检定和后续检定。 本规程不适用于数字心电图机、向量心电图机、心电监护仪等具有非线性系统及信息处理和用于特殊用途的心电测量仪器。

Verification Regulation of Electrocardiograph

JJG 1043-2008 脑电图机检定规程

本规程适用于最少具有8通道的用于医疗诊断的模拟脑电图机的首次检定和后续检定。 本规程不适用于信息处理脑电图仪、数字脑电图仪和特殊用途的脑电测量仪器。

Verification Regulation of Electroencephalographs

NF C74-122/A2:2008 医疗电气设备.第2-33部分:医疗诊断用磁共振设备的特殊要求

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

ANSI/AAMI/ISO/IEC 81060-1:2007 非侵入式血压计.第1部分:非自动测量式血压计的要求和试验方法

This standard specifies requirements for mechanical sphygmomanometers and their accessories that, by means of inflatable cuffs, are used for the non-invasive measurement of blood pressure. This standard also specifies requirements for the safety, essential performance, effectiveness, and labelling for these instruments and their accessories, including test methods to determine the accuracy of their measurements.

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type

YY 0319-2008 医用电气设备.第2-33部分: 医疗诊断用磁共振设备安全专用要求

本专用标准适用于由2.2.101定义的磁共振设备和由2.2.102定义的磁共振系统。 本标准不涵盖磁共振设备预期用途之外的应用。

Medical Electrical Equipment.Part 2-33:Particular Requirements for the Safety of Magnetic Reconance Equipment for Medical Diagnosis

YY/T 0639-2008 体外诊断医疗器械.制造商为生物学染色用体外诊断试剂提供的信息

本标准规定了制造商为生物学染色用试剂所提供信息的要求。本标准适用于染料、染色剂、发光试剂和用于生物学染色的其他试剂的生产商、供应商和零售商。在生物染色所有领域中，本标准所规定的制造商提供信息的要求，是获得可参照和可复现结果的先决条件。

In vitro diagnostic medical devices.Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

JJG 1042-2008 动态(可移动)心电图机检定规程

本规程适用于以下两种类型的动态（可移动）心电图机的首次检定、后续检定和使用中检验。 a) 可连续记录、分析心电图并实现全程回放。可先记录、存储后由独立工作站回放分析或记录、分析同时进行。 b) 可连续分析但仅部分记录，不提供全程回放。 本规程不适用于不能提供连续分析的间断性事件记录仪。

Vedfication Regulation for Ambulatory Electrocardiographs

JJG 1041-2008 数字心电图机检定规程

本规程适用于数字心电图机的首次检定、后续检定和使用中检验。 本规程不适用于模拟心电图机、矢量心电图机和其他特殊用途的专用心电图机的检定。

Verification Regulation for Digital Electrocardiographs

NF C74-335*NF EN 60601-2-37:2008 医用电气设备.第2-37部分:医疗用超声波诊断和监测设备的基本安全性和基本性能的详细要求

Medical electrical equipment - Part 2-37 : particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.