C39 医用电子仪器设备 标准查询与下载

BS EN ISO 80601-2-55:2018 医疗电气设备. 呼吸气体监测器的基本安全和主要性能的专用要求

Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors

DIN EN ISO 80601-2-56:2018 医疗电气设备.第2-56部分:测量体温用临床温度计的基本安全和基本性能的详细要求(ISO 80601-2-56-2017);德文版本EN ISO 80601-2-56-2017

This standard specifies the general, metrological and technical requirements for electrical clinical thermometers. This standard applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. The clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create medical electrical systems. This standard does not apply to such accessories. Medical electrical equipment that measures a temperature as a secondary function is outside the scope of this standard. Requirements for medical electrical equipment intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601-2-59.

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017); German version EN ISO 80601-2-56:2017

ISO 80601-2-61:2017 医疗电气设备.第2-61部分:脉动光电血氧计设备的基础安全性和基本性能详细要求

Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

JIS T 80601-2-61 ERRATUM 1:2017 勘误

ERRATUM

DIN EN 60601-2-26:2017 医疗电气设备.脑电描记器基本安全和基本性能的特殊要求(IEC 62D/1488/CDV-2017);德文版本prEN 60601-2-26-2017

This fourth edition cancels and replaces the third edition of IEC 60601-2-26 published in 2012. This edition constitutes a technical revision to align with Amendment 1:2012 to IEC 60601-1:2005, new versions of collateral standards and amendments thereto.

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph (IEC 62D/1488/CDV:2017); German version prEN 60601-2-26:2017

DIN EN 60601-2-10:2017 医疗电气设备. 神经和肌肉刺激器基本安全和基本性能的特殊要求(IEC 60601-2-10-2012+ A1-2016);德文版本EN 60601-2-10-2015+A1-2016

DIN EN 60601-2-10 (VDE 0750-2-10) is the alignment with regard to DIN EN 60601-1:2013 and Collateral Standards of the series DIN EN 60601-1-x.

Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10:2012 + A1:2016); German version EN 60601-2-10:2015 + A1:2016

IEC 60601-2-75:2017 医疗电气设备. 第2-75部分: 光能疗法和光能诊断设备基本安全和基本性能的详细要求

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS 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 document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This document applies to PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT used for compensation or alleviation of disease@ injury or disability. In the case of combined equipment (e.g. equipment additionally provided with a function or an APPLIED PART for the target area) such equipment shall also comply with any particular standard specifying safety requirements for the additional function. This particular standard does not apply to: ? light therapy equipment intended for use in photothermal ablation@ coagulation@ and hyperthermia; ? low-level laser therapy equipment not intended for use with a PHOTOSENSITIZER; ? illumination equipment intended for use in observation@ monitoring@ and diagnosis@ not intended for use with a PHOTOSENSITIZER.

Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

IEC TR 60601-4-1:2017 医疗电气设备. 第4-1部分: 指南和说明. 高度自治的医疗电气设备和医疗电气系统

This Part of IEC 60601 is intended to help a MANUFACTURER through the key decisions and steps to be taken to perform a detailed RISK MANAGEMENT and USABILITY ENGINEERING PROCESSES for MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM, hereafter referred to as MEE or MES, employing a DEGREE OF AUTONOMY (DOA). This document provides a definition of DOA of MEE or MES and a MEDICAL ROBOT, and also provides guidance on: methodologies to perform the RISK MANAGEMENT PROCESS and USABILITY ENGINEERING for an MEE or MES with a DOA; considerations of BASIC SAFETY and ESSENTIAL PERFORMANCE for an MEE and MES with a DOA; and; identifying the use of DOA, and similar concepts in existing ISO/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA; and; distinguishing between MEDICAL ROBOTS, and other MEE and MES. Unless specified otherwise, this document considers MEE and MES together. The MANUFACTURER of an MEE or MES with a DOA is expected to design and manufacture an MEE or MES that fulfils its INTENDED USE and does not have unacceptable RISK throughout its LIFE-CYCLE. This document provides guidance to help the MANUFACTURER in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for MEE and MES with DOA. The document is also intended as guidance for future standard writers. There are no prerequisites to this document.

Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy

YY/T 0492-2017 植入式心脏起搏器电极导线

Implantable pacemaker leads

YY/T 1519-2017 电生理标测导管

electrophysiological mapping catheter

JIS T 0601-1:2017 医用电气设备.第1部分:基本安全和基本性能的通用要求

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

JIS T 0601-2-2 ERRATUM 1:2016 勘误

ERRATUM

DIN EN 60601-2-63:2016 医疗电气设备.第2-63部分:牙科口外X射线设备基本安全和基本性能的特殊要求(IEC 60601-2-63-2012).德文版本EN 60601-2-63-2015

Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (IEC 60601-2-63:2012); German version EN 60601-2-63:2015

JIS Z 4924:2016 医疗诊断用磁共振设备用人体模型

Phantoms for magnetic resonance equipment for medical diagnosis

DIN EN 60601-2-18:2016 医疗电气设备.第2-18部分:内窥镜设备基本安全性和必要性能的详细要求(IEC 60601-2-18-2009).德文版本EN 60601-2-18-2015

Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment (IEC 60601-2-18:2009); German version EN 60601-2-18:2015

DIN EN 60601-2-49:2016 医疗用电气设备.第2-49部分:多功能病人监测设备基本安全和主要性能的专门要求(IEC 60601-2-49-2011).德文版本EN 60601-2-49-2015

Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment (IEC 60601-2-49:2011); German version EN 60601-2-49:2015

DIN EN 62570:2016 磁共振环境下医疗装置和其他物件的安全标记标准实施规程(IEC 62570-2014).德文版本EN 62570-2015

Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (IEC 62570:2014); German version EN 62570:2015

NF C74-011/A12*NF EN 60601-1/A12:2016 医疗电气设备. 第1部分: 基本安全和基本性能的通用要求

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

IEC 60601-2-40:2016 医疗电气设备. 第2-40部分: 肌电诱发电位系统基本安全和基本性能的详细要求

Replacement: This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT@ hereafter referred to as ME EQUIPMENT.

Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

DIN EN 60601-2-8:2016 医疗电气设备.第2-8部分:工作范围为10 kV至1 MV的X设备治疗设备基本安全和基本性能的特殊要求(IEC 60601-2-8-2010+A1-2015).德文版本EN 60601-2-8-2015+A1-2016

Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:2010 + A1:2015); German version EN 60601-2-8:2015 + A1:2016