C39 医用电子仪器设备 标准查询与下载

DIN EN 60601-2-57:2011 医疗用电气设备.第2-57部分:对治疗,诊断,检测和美容/美学的非激光光源的基本安全和基本性能的特殊要求(IEC 60601-2-57-2011);德文

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (IEC 60601-2-57:2011); German

IEC 60601-2-25:2011 医疗电气设备.第2-25部分:心电描记器基本安全性和基本性能的特殊要求

Replacement: This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS as defined in 201.3.63 intended by themselves or as a part of an ME SYSTEM@ for the production of ECG REPORTS for diagnostic purposes@ hereinafter referred to as ME EQUIPMENT. Not included within the scope of this particular standard are: a) the part of ME EQUIPMENT that provides vectorcardiographic loops; b) ambulatory electrocardiographic ME EQUIPMENT covered by IEC 60601-2-47 where not intended for obtaining ECG REPORTS for diagnostic purposes; c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining ECG REPORTS for diagnostic purposes. NOTE 1 For example. ME EQUIPMENT includes: a) direct-writing ELECTROCARDIOGRAPHS; b) other ME EQUIPMENT that produce ECG REPORTS for diagnostic purposes@ e.g. patient monitors@ defibrillators@ exercise testing devices; c) ELECTROCARDIOGRAPHS having a display that is remote from the PATIENT (e.g. via phone lines@ networks or storage media). These ME EQUIPMENT or ME SYSTEMS are within the scope of this particular standard excluding transmission media. NOTE 2 ME EQUIPMENT that provide selection between diagnostic and monitoring functions shall meet the requirements of the appropriate standard when configured for that function. ME 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 ME EQUIPMENT for those environments of use.

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

BS EN 60601-2-4:2011 医用电气设备.心脏除颤器基础安全和基本性能的特定要求

Medical electrical equipment. Particular requirements for the basic safety and essential performance of cardiac defibrillators

BS EN 60601-2-57:2011 医疗电气设备.用于治疗,诊断,监控和化妆/美学的非激光源设备的基本安全性和必要性能的特定要求

Replacement: This International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT). This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. LS EQUIPMENT may consist of a single or multiple sources of OPTICAL RADIATION, with or without power supply, or may be incorporated into a complex system that includes optical, electrical or mechanical systems or sources of other radiation.

Medical electrical equipment. Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

BS EN ISO 11073-10407:2011 健康信息学.个人健康设备通信.专门化设备.血压监护仪

IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or environmental protection in all circumstances. Implementers of the standard are responsible for determining appropriate safety, security, environmental, and health practices or regulatory requirements. This IEEE document is made available for use subject to important notices and legal disclaimers. These notices and disclaimers appear in all publications containing this document and may be found under the heading “Important Notice” or “Important Notices and Disclaimers Concerning IEEE Documents.” They can also be obtained on request from IEEE or viewed at http://standards.ieee.org/IPR/disclaimers.html. Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth blood pressure monitor devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth blood pressure monitors.

Health informatics. Personal health device communication. Device specialization. Blood pressure monitor

IEC 60601-2-34:2011 医用电气设备.第2-34部分:直接血压监测设备的基本安全性和必要性能的详细要求

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

ISO 80601-2-61:2011 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

Subclause 1.1 of The general standard is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessary for NORMAL USE, including the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER. These requirements also apply to PULSE OXIMETER EQUIPMENT, including PULSE OXIMETER MONITORS, PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS, which have been REPROCESSED. The intended use of PULSE OXIMETER EQUIPMENT includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of PATIENTS in professional healthcare institutions as well as PATIENTS in the HOME HEALTHCARE ENVIRONMENT. This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended for use in laboratory research applications nor to oximeters that require a blood sample from the PATIENT. 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 201.11 and in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This standard can also be applied to PULSE OXIMETER EQUIPMENT and their ACCESSORIES used for compensation or alleviation of disease, injury or disability. This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use. This International Standard is not applicable to remote or slave (secondary) devices that display SpO values that are located outside of the PATIENT ENVIRONMENT.

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

IEC 60601-1-11:2010/COR1:2011 医疗电气设备.第1-11部分:基本安全性和必要性能的一般要求.并行标准:家用医疗保健环境使用的医疗电气设备和医疗电气系统的要求

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-2-27:2011 医用电气设备.第2-27部分:心电图监护设备的基本安全性和必要性能用详细要求

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

DIN EN 60976:2011 医用电子设备.医用电子加速器.功能性特点(IEC 60976-2007);德文版本EN 60976-2007

Medical electrical equipment - Medical electron accelerators - Functional performance characteristics (IEC 60976:2007); German version EN 60976:2007

IEC 60601-2-49:2011 医用电气设备.第2-49部分:多功能病人监测设备的基本安全性和必要性能的详细要求

Replacement: This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in 201.3.63@ hereafter 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. 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. The scope of this standard is restricted to ME EQUIPMENT intended for connection to a single PATIENT that has either two or more APPLIED PARTS or MULTIPLE FUNCTIONS on an APPLIED PART. This standard does not specify requirements for individual monitoring functions such as ECG@ invasive pressure and pulse oximetry. The particular standards related to these physiological parameters specify requirements from the perspective of stand-alone ME EQUIPMENT. This particular standard addresses the differences related to MULTIFUNCTION PATIENT MONITORING EQUIPMENT@ since such equipment has a broader INTENDED USE than this stand-alone ME EQUIPMENT.

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

IEC 60601-2-23:2011 医用电气设备.第2-23部分:经皮分压监护设备的基本安全性和必要性能的详细要求

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

IEC 60601-2-57:2011 医疗电气设备.第2-57部分:用于治疗,诊断,监控和化妆/美学的非激光源设备的基本安全性和必要性能的详细要求

This International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT). This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy.

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

ANSI/IEEE 11073-10406:2011 健康信息学.个人保健装置通信.第10406部分:装置专门化.基本心电图仪(ECG)(1至3-指针ECG)

Health Informatics - Personal Health Device Communication - Device Specialization - Basic Electrocardiograph (ECG) (1 to 3- lead ECG)

KS P ISO 21647:2010 医疗电气设备.呼吸气监测器的基本安全和主要性能的特殊要求

다음의 경우를 제외하고 IEC 60601-1:1998의 1.이 적용된다.수정(1.1

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

YY 0782-2010 医用电气设备.第2-51部分:记录和分析型单道和多道心电图机安全和基本性能专用要求

增补：本专用标准规定了记录和分析型单道和多道心电图机的安全要求和基本性能要求。单道和多道心电图机已经在2.101，2.111，2.117,2.123，2.126中进行了定义，以下简称为设备。此类设备可能有人看管或无人看管的。本专用标准补充了GB 10793-2000。

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

YY 0783-2010 医用电气设备 第2-34部分：有创血压监测设备的安全和基本性能专用要求

本专用标准适用于在2.101中定义的有创血压监测和测量设备。 本专用标准不适用于穿刺导管、穿刺针、鲁尔(Luer)接头、活栓和活栓工作台。 本专用标准也不适用于无创血压监测设备。

Medical electrical equipment.Part 2-34:Particular requirements for the safety,including essential performance,of invasive blood pressure monitoring equipments

YY 0781-2010 血压传感器

本标准适用于经导管或直接的血管穿剌来测量血压的压力传感器，包括电缆。尽管本标准的要求和测试是围绕着以血压测量为预期用途的设备来进行研制与设计的，但是血压以外的生理参数的测量也可以用这种传感器。即使这个标准专注于血压测量的传感器的安全和功效，也宜关注确保专用传感器和血压监护设备的兼容性。 本标准的范围是包含设计用来测量血压的经留置导管或直接穿剌的传感器、电缆的安全和性能的要求，同时也给用户自己决定传感器和血压监护设备之间的兼容性提供参考。 本标准的范围是不包括被设计用于测量其他生理参数的传感器，本标准不阐述针对传感器或监护设备的操作程序，因此，参阅适合的使用说明书对于正确安装，平衡和校准该系统是完全必要的。 注：针对本标准条款制定和要求声明的原理性解释，请参见附录A。

Blood pressure transducers

YY 0785-2010 临床体温计 连续测量的电子体温计性能要求

本标准规定了连续测量的电子体温计的性能要求。 本标准适用于由电力驱动的设备，无论是用网电源还是内部电源供电。 此设备能够装备附加的指示装置、打印装置和其他辅助装置。这些附件的要求不在本标准适用范围内。 预期用于测量皮肤温度的温度计不在本标准适用范围内。 本标准并不打算排除基于其他测量原理的设备的适用性，这些设备在连续测量人体温度时能获得等同的性能。 注:设备可能包含一些适用于EN 12470的不同部分（见附录A)的功能。在这种情况下，制造商有责任指明哪些 功能分别适用于EN 12470的哪些部分。例如：具有最大温度记忆装置和可替换温度探头的电子体温计。

Clinical thermometers.Performance of electrical thermometers for continuous measurement

YY 0784-2010 医用电气设备 医用脉搏血氧仪设备基本安全和主要性能专用要求

引用GB 9706.1-2007的第1章,不包括以下内容。 修改(增加在1.1末尾处) 本标准详细描述了适用于人体使用的脉搏血氧仪设备的基本安全和主要性能的专用要求,该设备包括在正常使用中的任何必要的部件,如脉搏血氧监护仪、脉搏血氧探头、探头电缆延长线等。 这些要求也适用于经再加工的脉搏血氧仪设备,包括脉搏血氧监护仪,血氧探头和探头电缆延长线等。 脉搏血氧仪设备的应用范围包括,而不仅限于,在医疗保健机构和家庭中估计患者的动脉血氧饱和度和脉率。 本标准不适用于实验室研究使用的脉搏血氧仪设备,也不适用于需采集患者血液样本的血氧仪。 本标准不适用于胎儿专用脉搏血氧仪设备。 本标准不适用于放置于患者环境之外显示SpO数值的遥测或主(从)设备。 本标准的要求替代或修改了GB 9706.1-2007,并预期优先于相应的通用要求。

Medical electrical equipment.Particular requirements for the basic safety and essential performance of pulse oximeter equipement for medical use