C39 医用电子仪器设备 标准查询与下载

IEC TR 62348:2006 1998年修改版和IEC 60601-1第3版的附加条款之间的映射

This technical report provides a tool to assist users of IEC 60601-1 to trace requirements between the third edition and their source in the documents that form the basis of the third edition; principally the second edition as amended. This report is intended to be used by: – those who must align standards based on the second edition of IEC 60601-1 with the third edition; – manufacturers of medical electrical equipment or medical electrical systems; – health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment and medical electrical systems.

Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended

DIN EN ISO 10524-1:2006 医用气体设备用的压力调节器.第1部分:压力调节器和带流量计设备的压力调节器(ISO 10524-1-2006)

This Standard applies to pressure regulators intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients for use with the following medical gases: oxygen, nitrous oxide, air for breathing, helium, carbon dioxide, xenon, mixtures of these gases, air for driving surgical tools and nitrogen for driving surgical tools. These pressure regulators are intended to be fitted to cylinders with nominal filling pressures up to 25000 kPa at 15 ?and can be provided with devices to control and measure the flow of the medical gas delivered.#,,#

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006); English version of DIN EN ISO 10524-1:2006-05

BS EN ISO 11073-10201:2006 健康信息学.床旁检测医疗设备通信.传输轮廓.域信息模式

ISO/IEEE 11073-20101:2004 provides the upper layer [i.e., the International Organization for Standardization's (ISO's) open systems interconnection (OSI) application, presentation layer, and session layer] services and protocols for information exchange under the ISO/IEEE 11073 standards for medical device communications (MDC). ISO/IEEE 11073-20101:2004 is the base standard of the ISO/IEEE 11073-20000 medical device application profiles (MDAP), as harmonized through the Committee for European Normalization (CEN) and ISO.

Health informatics - Point-of-care medical device communication - Domain information model

BS EN ISO 11073-30200:2006 健康信息学.床旁检测医疗设备通信.传输轮廓.连接电缆

ISO/IEEE 11073-30200:2004 describes an IrDA-based, cable-connected local area network (LAN) for the interconnection of computers and medical devices and is suitable for new device designs, but is particularly targeted to modifications of legacy devices. The term legacy devices refers to equipment that is already in use in clinical facilities; in active production at the facilities of medical device manufacturers; beyond the initial stages of engineering development.

Health informatics - Point-of-care medical device communication - Transport profile - Cable connected

IEC 60601-2-47:2006 医用电气设备.第2-47部分:移动式心电描记系统安全(包括主要性能)的特殊要求

This Particular Standard specifies the particular safety requirements for AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, as defined in 2.101. 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 safety, including essential performance, of ambulatory electrocardiographic systems

NF C74-365:2006 医疗电子设备.第2-2部分:高频外科设备安全性的特殊要求

Medical electrical equipment - Part 2-2 : particular requirements for the safety of high frequency surgical equipment.

NF C74-206:2006 医疗电气设备.放射性核成像设备的特性和试验条件.γ射线照相机

Medical electrical equipment - Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras.

NF C74-340:2006 医疗电气设备.第2-4部分:心脏去纤颤器的特殊要求

Medical electrical equipment - Part 2-4 : particular requirements for the safety of cardiac defibrillators.

IEC 60601-2-33:2006 医用电气设备.第2-33部分:医疗诊断用磁共振设备的安全专用要求

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

IEC 60601-2-33/AMD1:2006 医用电气设备.第2-33部分:医疗诊断用磁共振设备的安全专用要求.修改件1

Establishes requirements for the safety of magnetic resonance equipment to provide protection for the patient. Establishes requirements to provide information to the operator, staff associated with magnetic resonance equipment and the general public. Pro

Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis; Amendment 1

ISO/TR 18112:2006 临床实验室试验和在实验室条件下诊断试验系统.在实验室条件下诊断用的专用医学设备.制造商提供信息的管理要求概要

This Technical Report summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use. Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use. Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and the United States are included. Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations from Australia are included for comparison. IVD medical devices for self-testing are excluded.

Clinical laboratory testing and in vitro diagnostic test systems - In vitro diagnostic medical devices for professional use - Summary of regulatory requirements for information supplied by the manufacturer

IEC 60601-2-49:2006 医用电气设备.第2-49部分:多功能病人监测设备安全的特殊要求

This Particular Standard applies to the safety requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in subclause 2.2.101. The scope of this standard is restricted to EQUIPMENT having either more than one APPLIED PART or more than one SINGLE FUNCTION, intended for connection to a single PATIENT. This standard does not specify requirements for individual monitoring functions.

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

ASTM F2213-06(2011) 测量磁共振环境中医疗设备上的磁感应扭矩的标准试验方法

This test method is one of those required to determine if the presence of a medical device may cause injury during a magnetic resonance examination and in the magnetic resonance environment. Other safety issues which should be addressed include but may not be limited to magnetically induced force (see Test Method F2052) and RF heating (see Test Method F2182). The terms and icons in Practice F2503 should be used to mark the device for safety in the magnetic resonance environment. If the maximal torque is less than the product of the longest dimension of the medical device and its weight, then the magnetically induced deflection torque is less than the worst case torque on the device due to gravity. For this condition, it is assumed that any risk imposed by the application of the magnetically induced torque is no greater than any risk imposed by normal daily activity in the Earth''s gravitational field. This is conservative; it is possible that greater torques would not pose a hazard to the patient. This test method alone is not sufficient for determining if an implant is safe in the MR environment. The sensitivity of the torque measurement apparatus must be greater than 1/10 the “gravity torque,” the product of device weight and the largest linear dimension. The torque considered here is the magneto-static torque due to the interaction of the MRI static magnetic field with the magnetization in the implant. The dynamic torque due to interaction of the static field with eddy currents induced in a rotating device is not addressed in this test method. Currents in lead wires may induce a torque as well.1.1 This test method covers the measurement of the magnetically induced torque produced by the static magnetic field in the magnetic resonance environment on medical devices and the comparison of that torque to the equivalent torque applied by the gravitational force to the implant. 1.2 This test method does not address other possible safety issues which include but are not limited to issues of magnetically induced force due to spatial gradients in the static magnetic field, RF heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the MR system. 1.3 The torque considered here is the magneto-static torque due to the interaction of the MRI static magnetic field with the magnetization in the implant. The dynamic torque due to interaction of the static field with eddy currents induced in a rotating device is not addressed in this test method. Currents in lead wires may induce a torque as well. 1.4 The sensitivity of the torque measurement apparatus must be greater than 1/10 the “gravity torque,” the product of the device''s maximum linear dimension and its weight. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

ASTM F2213-06 磁共振环境中医疗设备中磁感应扭矩测量的标准试验方法

This test method is one of those required to determine if the presence of a medical device may cause injury during a magnetic resonance examination and in the magnetic resonance environment. Other safety issues which should be addressed include but may not be limited to magnetically induced force (see Test Method F 2052) and RF heating (see Test Method F 2182). The terms and icons in Practice F 2503 should be used to mark the device for safety in the magnetic resonance environment. If the maximal torque is less than the product of the longest dimension of the medical device and its weight, then the magnetically induced deflection torque is less than the worst case torque on the device due to gravity. For this condition, it is assumed that any risk imposed by the application of the magnetically induced torque is no greater than any risk imposed by normal daily activity in the Earthrsquo;gravitational field. This is conservative; it is possible that greater torques would not pose a hazard to the patient. This test method alone is not sufficient for determining if an implant is safe in the MR environment. The sensitivity of the torque measurement apparatus must be greater than 1/10 the “gravity torque,” the product of device weight and the largest linear dimension. The torque considered here is the magneto-static torque due to the interaction of the MRI static magnetic field with the magnetization in the implant. The dynamic torque due to interaction of the static field with eddy currents induced in a rotating device is not addressed in this test method. Currents in lead wires may induce a torque as well.1.1 This test method covers the measurement of the magnetically induced torque produced by the static magnetic field in the magnetic resonance environment on medical devices and the comparison of that torque to the equivalent torque applied by the gravitational force to the implant.1.2 This test method does not address other possible safety issues which include but are not limited to issues of magnetically induced force due to spatial gradients in the static magnetic field, RF heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the MR system.1.3 The torque considered here is the magneto-static torque due to the interaction of the MRI static magnetic field with the magnetization in the implant. The dynamic torque due to interaction of the static field with eddy currents induced in a rotating device is not addressed in this test method. Currents in lead wires may induce a torque as well.1.4 The sensitivity of the torque measurement apparatus must be greater than 1/10 the "gravity torque," the product of the device's maximum linear dimension and its weight.This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

YY/T 0196-2005 一次性使用心电电极

本标准规定了用于诊断心电图机或心电监护的一次性使用电极的标记、安全和性能的最低要求。 任何由传感元件和电解质组成的一次性使用心电电极系统(参见3.4)都包括在本标准范围内。 活性电极、针状电极、可重复使用(非一次性使用)电极、用于传递能量的电极和主要设计用来测量心电以外的生理电信号的电极(例如：用于呼吸暂停监护中非心电用途的电极，如电阻描迹)不包括在本标准范围内。关于电解质组成的要求也不在本标准范围内。

Disposable ECG electrodes

KS X ISO 18812:2005 健康信息学.医用分析仪与实验室信息系统的接口.使用说明文件

? ??? ?? ??? ?? ?? ??(AI) ? ?? ?? ???(LIS) ??? ??

Health informatics-Clinical analyzer interfaces to laboratory information systems-Use profiles

IEC TR 62354:2005 医疗电气设备的一般试验规程

This Technical Report applies to MEDICAL ELECTRICAL EQUIPMENT (as defined in Subclauses 3.63 of IEC 60601-1:2005 and 2.2.15 of IEC 60601-1:1988), hereinafter referred to as ME EQUIPMENT.

General testing procedures for medical electrical equipment

IEC 60601-2-51:2005 医用电气设备.第2-51部分:单道和多道心电描记器记录和分析的安全(包括基本特性)的特殊要求

Establishes particular requirements, in addition to the requirements of IEC 60601-2-25, for the safety, including essential performance of recording and analysing single channel and multichannel electrocardiographs. These requirements shall apply particu

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

IEC 60601-1:2005 医用电气设备.第1部分:基本安全和基本性能的一般要求

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELETRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS,hereafter referred to as ME EQUIPMENT and 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 teh intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirement in this standard except in 7.2.13 and 8.4.1. This standard can also be applied to equipment used for compensation or alleviation of desease,injury or disabiliby. In vitro diagnostic equipment that does not fall within the defintion fo ME EQUIPMENT is covered by the IEC 61010 series 2).This standard does not apply to the implantable parts of active implantable medical divices covered by ISO 14708-1 3).

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

NF C74-305/A1:2005 医用电气设备.第2-25部分:心电图机安全专用要求.

Medical electrical equipment - Part 2-25 : particular requirements for the safety of electrocardiographs.