C39 医用电子仪器设备 标准查询与下载

IEC 60601-2-66:2012 医用电气设备.第2-66部分:听力仪器和听力仪表系统基本安全性和必要性能的详细要求

Replacement: This International Standard applies to the BASIC SAFETY of HEARING INSTRUMENTS and HEARING INSTRUMENT SYSTEMS@ hereafter also referred to as ME EQUIPMENT or ME SYSTEM. If a clause or subclause is specifically intended to be applicable to HEARING INSTRUMENTS only@ or to HEARING INSTRUMENT 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 HEARING INSTRUMENTS and to HEARING INSTRUMENT SYSTEMS@ as relevant. HAZARDS inherent in the intended physiological function of HEARING INSTRUMENTS or HEARING INSTRUMENT SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 201.7.9.2 and 201.9.6. NOTE See also 201.4.2. (RISK MANAGEMENT). ACCESSORIES to HEARING INSTRUMENTS in the HOME HEALTHCARE ENVIRONMENT (e.g. remote control units@ audio streamers@ battery chargers@ power supplies) are covered by the most applicable standard@ IEC 60065@ IEC 60950-1 or other applicable IEC safety standards. Alternatively the general standard may be applied. HEARING INSTRUMENTS do not have a MAINS PART intended for connection to a.c. SUPPLY MAINS. The connection to the SUPPLY MAINS of a HEARING INSTRUMENT system is covered by power supply@ charger or other types of ACCESSORIES. ACCESSORIES connected to a HEARING INSTRUMENT may form a HEARING INSTRUMENT SYSTEM. Only the HEARING INSTRUMENT and its detachable parts are subject to all applicable clauses of this particular standard. The remaining components of the HEARING INSTRUMENT SYSTEM are subject to requirements of this particular standard that result from their connection to the HEARING INSTRUMENT SYSTEM. Programming interfaces or ACCESSORIES in a clinical application are covered by the general standard. NOTE Detachable parts of HEARING INSTRUMENTS even if supplied separately (e.g. ear hooks@ domes@ wax guards etc.)@ are not regarded as ACCESSORIES. This standard does not apply to: ?C cochlear implants or other implanted HEARING INSTRUMENTS; ?C bone conduction HEARING INSTRUMENTS; ?C educational HEARING INSTRUMENTS (i.e. group HEARING INSTRUMENTS@ auditory trainers etc.); ?C the application of a HEARING INSTRUMENT for the measurement of hearing levels. IEC 60645-1 applies; ?C audio-frequency induction-loop systems or their component parts@ as described in IEC 60118-4 and IEC 62489-1; ?C assisted HEARING INSTRUMENT SYSTEMS using infra-red or radio; ?C the sound generating function of a tinnitus masker.

Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

NF C74-331*NF EN 60601-2-46:2012 医疗电气设备 - 第2-46部分: 操作台基本安全和主要性能的特殊要求.

Medical electrical equipment - Part 2-46 : particular requirements for basic safety and essential performance of operating tables.

BS EN ISO 80601-2-55:2011 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

IEC 60601-1:2005/AMD1:2012 医用电气设备.第1部分:基本安全性和必要性能的通用要求.修改件1

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

JJG 714-2012 血细胞分析仪检定规程

本规程适用于血细胞分析仪的首次检定、后续检定和使用中检查。

Verification Regulation of Blood Cell Analyzers

JIS T 0601-1:2012 医用电气设备.第1部分:基本安全和基本性能的通用要求

This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, (hereafter referred to as ME EQUIPMENT and ME SYSTEMS).

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

IEC 60601-2-26:2012 医用电气设备.第2-26部分:脑电图机基本安全性和必要性能的详细要求

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

IEC 60601-2-27:2011/COR1:2012 医用电气设备.第2-27部分:心电监护设备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 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; Corrigendum 1

NF C74-358*NF EN 60601-2-57:2012 医疗电气设备. 第2-57部分: 预期供治疗, 诊断, 监测和美容/美学使用非激光光源设备的基本安全和基本性能的详细要求.

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

DIN EN 60601-2-31:2012 医疗电气设备.第2-31部分:用内供电源的体外心脏起博器基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source (IEC 60601-2-31:2008 + A1:2011); German version EN 60601-2-31:2008 + A1:2011

DIN EN ISO 80601-2-55:2012 医用电气设备.第2-55部分:呼吸气体监测器的基本安全和基本性能专用要求(ISO 80601-2-55-2011).德文版本 EN ISO 80601-2-55-2011

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011); German version EN ISO 80601-2-55:2011

IEC 60601-2-33:2010/COR1:2012 医用电气设备.第2-33部分:医疗诊断用核磁共振设备的基本安全性和必要性能详细要求

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS@ hereafter referred to also as ME EQUIPMENT. This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE. 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. The standard does not formulate ESSENTIAL PERFORMANCE requirements related to INTERVENTIONAL MR EXAMINATIONS.

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis; Corrigendum 1

IEC 60601-2-47:2012 医用电气设备.第2-47部分:移动式心电描记系统基础安全(主要性能)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

KS C IEC 60601-2-56:2012 医用电气设备.第2-56部分:体温测量用临床体温计的基本安全与基本性能的特殊要求

Medical electrical equipment. Part 2-56: Special requirements for basic safety and basic performance of clinical thermometers for temperature measurement

KS C ISO 80601-2-56:2012 医用电气设备.第2-56部分:体温测量用临床体温计的基本安全和基本性能的个性化需求

이 표준은 임상 체온계 및 그 부속품의 기본안전 및 필수성능(BASIC SAFETY and

Medical electrical equipment－Part 2-56：Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

KS C IEC 60601-1-9:2012 医疗电气设备.第1-9部分:基本安全和重要性能的通用要求.附属标准:环境意识设计的要求

이 표준은 의료용 전기기기[이후로 의료용 전기기기(ME 기기)로 명칭]의 유해한 환경영향의

Medical electrical equipment－Part 1-9：General requirements for basic safety and essential performance－Collateral Standard：Requirements for environmentally conscious design

ANSI/3-A P3-A 003-2012 有效药物成分用端吸离心泵药品3-A卫生标准/保健标准

This standard covers the sanitary design requirements of mechanically sealed end-suction centrifugal pumps conforming to ANSI/ASME B73.1, pertinent to active pharmaceutical ingredient (API) manufacturing n order to maintain product integrity.

Pharmaceutical 3-A Sanitary Standard/Hygienic Standard for End Suction Centrifugal Pumps for Active Pharmaceutical Ingredients

ANSI/AAMI/IEC 60601-2-25:2012 医用电气设备.第2-25部分:心电图仪基本安全性和基本性能详细要求

Specifies basic safety and essential performance requirements for electrocardiographs for the production of ECG reports for diagnostic purposes. This particular standard does not include the part of electrocardiographs that povides vector loops, ambulatory electrocardiographic equipment covered by IEC 60601-2-47, and cardiac monitors covered by IEC 60601-2-27.

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

ANSI/AAMI/IEC 60601-2-16,Ed. 4:2012 医用电气设备.第2-16部分:血液透析,血液透析滤过和血液滤过设备的基本安全性和必要性能的详细要求

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

YY 0828-2011 心电监护仪电缆和导联线

本标准适用于YY 1079-2008《心电监护仪》标准所定义的心电监护仪使用的进行体表心电（ECG）监护的电缆和患者导联线。

ECG cables and leadwires