11.040.55 诊断设备 标准查询与下载

IEC 80601-2-71:2015 医用电气设备.第2-71部分:功能性近红外光谱（NIRS）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 FUNCTIONAL NIRS EQUIPMENT intended to be used by themselves@ or as a part of an ME SYSTEM@ for the production of FUNCTIONAL NIRS EQUIPMENT output for adjunctive diagnostic purposes@ hereinafter referred to as ME EQUIPMENT. Not included within the scope of this particular standard are: a) the part of ME EQUIPMENT@ if provided@ that measures oxygen saturation of the haemoglobin in the micro vessels (capillaries@ arterioles and venules); b) near-infrared spectroscopy (NIRS) tissue oximeter equipment@ which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output; c) pulse oximeter equipment@ which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output. The requirements for pulse oximeter equipment are found in ISO 80601-2-61. d) frequency-domain and time-domain equipment for functional near-infrared spectroscopy@ which may require different test procedures than defined herein. e) FUNCTIONAL NEAR-INFRARED SPECTROSCOPY EQUIPMENT which measure changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin@ which may require different test procedures than defined herein.

Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional Near-Infrared Spectroscopy (NIRS) equipment

EN 60601-2-47:2015 医用电气设备.第2-47部分:移动式心电扫描设备安全(包括主要性能)专用要求

IEC 60601-2-47:2012 concerns the basic safety and essential performance of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements the general standard IEC 60601-1 (third edition 2005). The requirements of this particular standard take priority over those of the general standard. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG. The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories. If the AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. MEDICAL ELECTRICAL EQUIPMENT covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard. This standard does not apply to systems that do not continuously record and analyse the ECG (for example, 'intermittent event recorders'). This second edition cancels and replaces the first edition published in 2001. It constitutes a technical revision. This edition was revised to align structurally with the 2005 edition of IEC 60601-1.

Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

EN 60601-2-26:2015 医用电气设备.第2-26部分:脑电图机安全专用要求

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

BS ISO 8600-2:2015 内窥镜 医用内窥镜和内窥镜治疗设备 硬质支气管镜的特殊要求

Endoscopes. Medical endoscopes and endotherapy devices. Particular requirements for rigid bronchoscopes

DIN EN 60601-2-27:2015 医用电气设备.第2-27部分:心电图监护设备基本性能安全性专用要求 (IEC 60601-2-27-2011+Cor.-2012);德文版本EN 60601-2-27-2014

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (IEC 60601-2-27:2011 + Cor.:2012); German version EN 60601-2-27:2014

ISO 8600-2:2015 光学和光学仪器.医疗内窥镜和内窥镜附件.第2部分:硬支气管内窥镜的特殊要求

This part of ISO 8600 specifies requirements for rigid bronchoscopes and their endoscopic accessories used in the practice of anaesthesia and medical endoscopy.

Endoscopes - Medical endoscopes and endotherapy devices - Part 2: Particular requirements for rigid bronchoscopes

DIN EN 60601-2-34:2015 医疗电气设备. 第2-34部分: 侵入性血压监测设备基本安全和基本性能的特殊要求 (IEC 60601-2-34-2011); 德文版本EN 60601-2-34-2014

Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment (IEC 60601-2-34:2011); German version EN 60601-2-34:2014

GOST R IEC 60601-2-47-2015 医疗电气设备. 第2-47部分. 不卧床的心电描记系统基本安全和基本性能的特殊要求

Medical electrical equipment. Part 2-47. Particular requirements for basic safety and essential performance of ambulatory electrocardiographic systems

GOST 25377-2015 可重复使用的注射针. 规格

Needles for injections for repeated use. Specifications

GOST R IEC 60601-2-49-2015 医疗电气设备. 第2-49部分. 多功能病人监测设备基本安全和基本性能的特殊要求

Medical electrical equipment. Part 2-49. Particular requirements for basic safety and essential performance of multifunction patient monitoring equipment

GSO IEC 60601-2-34:2014 电气医疗器械 第2-34部分：诊断血压监测装置基本安全和基本性能的特殊要求

Replacement: This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter referred to as ME EQUIPMENT. This particular standard does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables that connect to the DOME. This particular standard does not apply to NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT.

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

GSO IEC 60601-2-28:2014 医疗电气设备 第2部分 28：医疗诊断用X射线源组件基本安全和内在性能的特殊要求

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof: – hereafter referred to as ME EQUIPMENT; – intended for medical diagnosis and imaging. 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. NOTE This International Standard is also applicable to the X-RAY TUBE ASSEMBLY aspects of X-RAY SOURCE ASSEMBLIES and X-RAY TUBE HEADS.

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

GSO IEC 60601-2-33:2014 电气医疗器械 第2-33部分：医疗诊断磁共振设备基本安全和基本性能的特殊要求

IEC 60601-2-33:2010 establishes particular basic safety and essential performance requirements for magnetic resonance equipment to provide protection for the patient and the magnetic resonance worker. This third edition cancels and replaces the second edition published in 2002, its Amendment 1 (2005) and Amendment 2 (2007) and constitutes a technical revision. This third edition of IEC 60601-2-33 is based on the second amendment to Edition 2. It has also been adapted to the third edition of IEC 60601-1 (2005), with technical modifications being introduced where appropriate. The contents of the corrigenda of March 2012 and February 2016 have been included in this copy.

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

GSO IEC 60601-2-23:2014 医用电气设备 第2-23部分：经皮分压监测设备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 TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter referred to as ME EQUIPMENT, whether this ME EQUIPMENT is stand alone or part of a system. This standard applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth. This standard does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa). 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 the general standard. NOTE See also 4.2 of the General Standard.

Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

DIN EN ISO 81060-2:2014 非侵入式血压计. 第2部分: 自动测量类型的临床研究 (ISO 81060-2-2013); 德文版本EN ISO 81060-2-2014

Non-invasive sphygmomanometers - Part 2: Clinical invastigation of automated measurement type (ISO 81060-2:2013); German version EN ISO 81060-2:2014

BS EN 60601-2-34:2014 医疗电气设备. 侵入性血压监测设备基本安全和基本性能的特殊要求

Medical electrical equipment. Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

EN 60601-2-34:2014 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

IEC 60601-2-34:2011 concerns the basic safety and essential performance of invasive blood pressure monitoring equipment. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The third edition of IEC 60601-2-34 cancels and replaces the second edition published in 2001 and constitutes a technical revision in order to align structurally with the 2005 edition of IEC 60601-1. IEC 60601-2-34 applies to basic safety and essential performance of invasive blood pressure monitoring equipment. It does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables connected. It does not apply to non-invasive blood pressure monitoring equipment.

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

EN ISO 81060-2:2014 无创伤性血压计.第2部分:自动化测量型的临床验证(ISO 81060-2:2013)

Dieser Teil der ISO 81060 legt Anforderungen und Verfahren der KLINISCHEN PRUFUNG fur ME-GERATE (MEDIZINISCHES ELEKTRISCHES GERAT) fest, die zur nichtkontinuierlichen nichtinvasiven automatischen Schatzung des arteriellen BLUTDRUCKS unter Verwendung einer MANSCHETTE eingesetzt werden. Dieser Teil der ISO 81060 gilt fur alle NICHTINVASIVEN BLUTDRUCKMESSGERATE, die zur Schatzung, Anzeige oder Aufnahme des BLUTDRUCKS Pulsationen, Fluss oder Gerausche detektieren oder anzeigen. Diese NICHTINVASIVEN BLUTDRUCKMESSGERATE brauchen die MANSCHETTE nicht unbedingt automatisch aufpumpen konnen. Dieser Teil der ISO 81060 behandelt NICHTINVASIVE BLUTDRUCKMESSGERATE, die fur alle PATIENTEN-Gruppen (z.B. alle Alters- und Gewichtsbereiche) und alle Anwendungsbedingungen geeignet sind (z. B. fur die ambulante Langzeit-BLUTDRUCK-Uberwachung, BLUTDRUCK-Uberwachung unter Belastung und BLUTDRUCK-Selbstmessung bei der MEDIZINISCHEN VERSORGUNG IN HAUSLICHER UMGEBUNG sowie fur die Nutzung in einer professionellen Gesundheitseinrichtung). BEISPIEL AUTOMATISIERTES NICHTINVASIVES BLUTDRUCKMESSGERAT wie in IEC 80601-2-30 beschrieben, KLINISCH GEPRUFT nach diesem Teil der ISO 81060. Dieser Teil der ISO 81060 legt zusatzliche Anforderungen fur die Beschreibung in den BEGLEITPAPIEREN von NICHTINVASIVEN BLUTDRUCKMESSGERATEN, KLINISCH GEPRUFT nach diesem Teil der ISO 81060, fest. Dieser Teil der ISO 81060 gilt nicht fur KLINISCHE PRUFUNGEN NICHT-AUTOMATISIERTER NICHTINVASIVER BLUTDRUCKMESSGERATE beschrieben in ISO 81060-1 oder INVASIVER BLUTDRUCKMESSGERATE beschrieben in IEC 60601-2-34.

Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type

DIN EN 60601-1-8:2014 医疗电气设备. 第1-8部分: 基本安全和基本性能的一般要求. 副标准: 医疗电气设备和医疗电气系统警报系统的一般要求, 试验和指南(IEC 60601-1-8-2006 + A1-2012); 德文版本EN 60601-1-8-2007 + Cor. -2010 + A1-2013

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

BS ISO 8600-4:2014 内窥镜. 医用内窥镜和内疗器件. 插入部分最大宽度的测定

Endoscopes. Medical endoscopes and endotherapy devices. Determination of maximum width of insertion portion