11.040.55 诊断设备 标准查询与下载

KS P IEC 60601-2-33-2003 用于医疗诊断的磁共振设备

Magnetic resonance equipment for medical diagnosis

KS P IEC 60601-2-33:2003 磁共振计算机断层扫描装置

Magnetic resonance equipment for medical diagnosis

ISO 8600-3:1997/Amd 1:2003 光学和光学仪器.医用内窥镜和内窥镜附件.第3部分:光学内窥镜观察方向和观察区域的测定.修改件1

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Amendment 1 to ISO 8600-3:1997 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 5, Microscopes and endoscopes.

Optics and optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics; Amendment 1

IEC 60601-2-26:2003 医用电气设备.第2-26部分:脑电图机安全的特殊要求

Specifies the particular safety requirements for electroencephalographs, i.e. devices to produce an electroencephalogram. This Particular Standard amends and supplements IEC 60601-1 (1988): Medical electrical equipment - Part 1: General requirements for

Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs

BS EN 60601-2-51:2003 医疗电气设备.记录和分析单道和多道心电描记器的安全性特殊要求(包括主要性能)

Addition: This Particular Standard specifies requirements for the safety, including essential performance, of RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS as defined in 2.101, 2.111, 2.117, 2.123, 2.126, hereinafter referred to as EQUIPMENT. The EQUIPMENT may be attended or unattended. This Particular Standard complements IEC 60601-2-25 and its Amendment 1 (1999).

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

CAN/CSA-C22.2 No.60601-2-47-2003(R2012) 医用电气设备 第2-47部分：动态心电图系统安全（包括基本性能）的特殊要求

This National Standard of Canada is equivalent to International Standard IEC 60601-2-47:2001 (first edition, 2001-07). 1.1 Scope Addition: 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 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").

Medical Electrical Equipment - Part 2-47: Particular Requirements for the Safety, Including Essential Performance, of Ambulatory Electrocardiographic Systems

BS EN 60601-2-26:2003 医用电气设备.安全性详细要求.脑电描记器安全性详细要求

Addition: This Particular Standard specifies the particular safety requirements for ELECTRO-ENCEPHALOGRAPHS as defined in 2.2.103 and also referred to as EQUIPMENT. The special requirements for other equipment also used in electroencephalography are not covered by this standard, for example: - cerebral function monitors; - phono-photic stimulators; - electroencephalographic telemetry; - EEG data storage and retrieval; - EQUIPMENT particularly intended for monitoring during electro-convulsive therapy; - ambulatory electroencephalographic recorders.

Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of electroencephalographs

IEC 60601-1-8:2003 医疗电气设备.第1-8部分:安全的一般要求.并列标准.医疗电气设备和医疗电气系统中警报系统的一般要求、试验和指南

This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS.

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

EN 60601-2-51:2003 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性的特殊要求 IEC 60601-2-51-2003

Medical electrical equipment Part 2-51: Particular requirements for safety@ including essential performance@ of recording and analysing single channel and multichannel electrocardiographs (Remains Current)

YY 0109-2003 医用超声雾化器

本标准规定了医用超声雾化器的分类、要求、试验方法、检验规则以及标志、使用说明书。 本标准适用于利用超声波对液态药物进行雾化的超声雾化器，该产品主要供吸入治疗，也可用于医疗环境的空气加湿。

Medical ultrasonic nebulizer

YY 0455-2003 医用电气设备.第2部分:婴儿辐射保暖台安全专用要求

本专用标准适用于2.2.101定义的婴儿辐射保暖台的安全要求。 供医院婴儿护理环境外使用的婴儿辐射保暖台、有加热垫的婴儿辐射保暖台和由内部电源供电的婴儿辐射保暖台的安全专用要求，不包括在本标准内。

Medical electrical equipment-Part 2:Particular requirments for the safety of infant radiant warmers

BS EN ISO 15197:2003 体外诊断试验系统.糖尿病症管理中自测用血糖监测系统的要求

This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users. These systems are intended for self-testing by laypersons for management of diabetes mellitus. This International Standard is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems. This International Standard does not ? provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, ? pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus, ? address the medical aspects of diabetes mellitus management, or ? apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

AS/NZS 4713:2002 超声波．物理疗法系统．0.5 MHz-5 MHz频率范围的性能要求和测量方法

Specifies performance requirements for ultrasonic equipment designed for physiotherapy, consisteing of an ultrasonic transducer generating continuous or quasi-continuous wave ultrasonic energy in the frequency range 0.5 MHz and 5 MHz. It mofifies, and has been reproduced from, IEC 61689:1996 with variations for Australia and New Zealand included in a ZZ Appendix.

Ultrasonics - Physiotherapy systems - Performance requirements and methods of measurement in the frequency range 0.5 MHz to 5 MHz

DIN EN 60601-2-49:2002 医疗电气设备.第2-49部分:多功能病人监测设备安全的特殊要求 (IEC 60601-2-49:2001); 德文版本 EN 60601-2-49:2001

Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment (IEC 60601-2-49:2001); German version EN 60601-2-49:2001

DIN EN 60601-2-47:2002 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

Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001); German version EN 60601-2-47:2001

IEC 60601-2-26:2002 医用电气设备.第2-26部分:脑电图机安全的特殊要求

Addition:This Particular Standard specifies the particular safety requirements for ELECTRO-ENCEPHALOGRAPHS as defined in 2.2.103 and also referred to as EQUIPMENT.The special requirements for other equipment also used in electroencephalography are not covered by this standard@ for example:? cerebral function monitors;? phono-photic stimulators;? electroencephalographic telemetry;? EEG data storage and retrieval;? EQUIPMENT particularly intended for monitoring during electro-convulsive therapy;? ambulatory electroencephalographic recorders.

Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs

BS EN 60601-2-33:2002 医用电气设备.安全性特殊要求.医疗诊断用磁共振设备的安全性特殊要求

Addition: This Particular Standard applies to MAGNETIC RESONANCE EQUIPMENT as defined in 2.2.101 and MAGNETIC RESONANCE SYSTEMS as defined in 2.2.102. This Standard does not cover the application of MAGNETIC RESONANCE EQUIPMENT beyond the INTENDED USE.

Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

BS EN 60601-2-33:2002+A2:2008 医用电气设备.第2-33部分:医疗诊断用磁共振设备的安全性详细要求

This Particular Standard applies to MAGNETIC RESONANCE EQUIPMENT as defined in 2.2.101 and MAGNETIC RESONANCE SYSTEMS as defined in 2.2.102. This Standard does not cover the application of MAGNETIC RESONANCE EQUIPMENT beyond the INTENDED USE.

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

LST EN 60601-2-49-2002 医疗电气设备 第 2-49 部分：多功能患者监护设备安全的特殊要求（IEC 60601-2-49:2001）

Medical electrical equipment. Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment (IEC 60601-2-49:2001)

LST EN 60601-2-47-2002 医疗电气设备 第 2-47 部分：动态心电图系统的特殊安全要求，包括基本性能（IEC 60601-2-47:2001）

Medical electrical equipment. Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001)