11.040.55 诊断设备 标准查询与下载

BS PD ISO/TS 18339:2015 内疗器械. 目镜盖和导光连接器

Endotherapy devices. Eyepiece cap and light guide connector

BS EN 60601-2-23:2015 医疗电气设备 经皮分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 transcutaneous partial pressure monitoring equipment

NF C74-335/A1*NF EN 60601-2-37/A1:2015 医疗电气设备. 第2-37部分: 超声医学诊断和监测设备基本安全和基本性能的特殊要求

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

ISO/TS 18339:2015 内疗器械. 目镜盖和导光连接器

Endotherapy devices - Eyepiece cap and light guide connector

BS PD ISO/TS 18340:2015 内窥镜. 与套管针套一起使用的套管针针头, 套管针套和内疗器械

Endoscopes. Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves

BS ISO 8600-1:2015 内窥镜 医用内窥镜和内窥镜治疗设备 一般要求

Endoscopes. Medical endoscopes and endotherapy devices. General requirements

EN 60601-2-25:2015 医用电气设备.第2-25部分:心电图机安全的特殊要求

IEC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are: a) the part of Medical electrical equipment that provides vectorcardiographic loops; b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes; c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes. This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

EN 60601-2-23:2015 医用电气设备.第2部分:经皮分压监测设备的安全专用要求

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

EN 60601-2-49:2015 医用电气设备.第2-49部分:多功能病人监护设备安全的特殊要求

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

ISO/TS 18340:2015 内窥镜. 与套管针套一起使用的套管针针头, 套管针套和内疗器械

Endoscopes - Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves

ISO 8600-1:2015 内窥镜.医用内窥镜和内疗器件.第1部分:通用要求

This part of ISO 8600 gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.

Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements

NF C74-342*NF EN 60601-2-26:2015 医疗电气设备. 第2-26部分: 脑电图机基本安全和基本性能的特殊要求

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

GSO ISO 19001:2015 体外医疗诊断设备 制造商信息和用于生物学染色的体外诊断试剂

This International Standard specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology. The requirements for information supplied by the manufacturer specified in this International Standard are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.

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

GSO IEC 60601-2-27:2015 医用电气设备 第2-27部分：心电监护设备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 ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter also referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However,MANUFACTURERS should consider using relevant clauses of this standard as appropriate for their INTENDED USE. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard.

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

GSO IEC 60601-2-47:2015 电气医疗设备第 2 47 部分：动态心电图系统基本安全和性能的特殊要求

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, hereafter referred to as ME SYSTEMS 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. 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. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously.The type of storage media used is irrelevant with regard to this standard; 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 abovementioned 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’).

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

NF C74-388/A1*NF EN 80601-2-30/A1:2015 医疗电气设备. 第2-30部分: 自动无创血压计基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-30 : particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

BS EN 60601-2-47:2015 医疗电气设备 动态心电图系统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 ambulatory electrocardiographic systems

IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV 医用电气设备 第2-33部分 特殊要求 为了磁共振的基本安全和基本性能 医疗诊断设备

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

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