11.040.55 诊断设备 标准查询与下载
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Medical electrical equipment－Part 2－51：Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
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- 11.040.55
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- 发布
- 20131231
- 实施
- 20131231
Medical electrical equipment－Part 2－51：Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
- ICS
- 11.040.55
- CCS
- 发布
- 2013-12-31
- 实施
This part of IEC 62563 describes the evaluation methods for testing medical IMAGE DISPLAY SYSTEMS. The scope of this International Standard is directed to practical tests that can be visually evaluated or measured using basic test equipment. More advanced or more quantitative measurements can be performed on these devices, but these are beyond the scope of this document. This standard applies to medical IMAGE DISPLAY SYSTEMS, which can display monochrome image information in the form of greyscale values on colour and greyscale IMAGE DISPLAY SYSTEMS (e.g. CATHODE RAY TUBE (CRT) monitors, FLAT PANEL DISPLAYS, PROJECTION SYSTEM). This standard applies to medical IMAGE DISPLAY SYSTEMS used for diagnostic (interpretation of medical images toward rendering clinical diagnosis) or viewing (viewing medical images for medical purposes other than for providing a medical interpretation) purposes and therefore having specific requirements in terms of image quality. Head mounted IMAGE DISPLAY SYSTEMS and IMAGE DISPLAY SYSTEMS used for confirming positioning and for operation of the system are not covered by this standard. It is not in the scope of this standard to define the requirements of acceptance and constancy tests nor the frequencies of constancy tests.
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
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- 11.040.55
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- 发布
- 2013-12-31
- 实施
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of humans under indoor environmental conditions, hereafter referred to as ME EQUIPMENT. This International Standard sets laboratory characterization test limits for the SCREENING THERMOGRAPH. NOTE A SCREENING THERMOGRAPH is intended for screening and detection of human subjects with SKIN TEMPERATURES elevated above normal. An elevated SKIN TEMPERATURE needs to be followed up by a subsequent temperature measurement using a clinical thermometer (see IEC 80601-2-56). 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.
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
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- 11.040.55
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- 发布
- 2013-12-31
- 实施
This International Standard specifies the description of PULSE SEQUENCES of MAGNETIC RESONANCE imaging. NOTE The classification in this standard is suitable for: – tender texts; – image annotation; – protocol definition; – technical publications. This International Standard does not apply to MAGNETIC RESONANCE spectroscopy. The classification does not focus on image contrast (T1, T2, proton density), as this is defined by PULSE SEQUENCE parameters (e.g. repetition time, echo time) and is not a property of the PULSE SEQUENCE alone. The PULSE SEQUENCE classification does not specify the K-SPACE acquisition scheme, reconstruction algorithm or post-processing.
Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences
- ICS
- 11.040.55
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- 发布
- 2013-12-31
- 实施
Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (IEC 61157:2007 + A1:2013); German version EN 61157:2007 + A1:2013
- ICS
- 11.040.55
- CCS
- C41
- 发布
- 2013-11
- 实施
- 2013-11-01
1范围和目的除下述内容外,通用标准的本章适用。1.1范围增补:本专用标准规定了适用于2.101所定义的动态心电图系统的专用安全要求。以下类型的系统在本标准的范围内:a) 可连续记录和分析心电图的系统,并且该系统在对心电图进行完整的重新分析时能给出基本相同的结果。这个系统可以先记录和储存心电图,然后在一个独立的单元进行分析,或者记录和分析同时进行。本标准不涉及所用储存媒介的类型;b)能够提供连续分析和部分或有限的记录,但不能对心电图进行完整的重新分析的系统。满足上述任一类型的系统均适用于本标准的安全要求。如果动态心电图系统提供自动心电图分析,则适用本标准规定的测量和分析功能的最低性能要求。由GB 10793-2000和GB 9706.25-2005所覆盖的医用电气设备不在本标准的范围内。本标准不适用于不能对心电图进行连续记录和分析的系统(例如,“间歇事件记录仪”)。1.2目的替换:本专用标准的目的是为了制定对动态心电图系统安全和基本性能的专用要求。
Medical electrical equipment.Part 2:Particular requirements for the safety, including essential performance of ambulatory electrocardiographic systems
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- 11.040.55
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- C39
- 发布
- 2013-10-21
- 实施
- 2014-10-01
This part of ISO 8600 specifies a method of measurement of the maximum width of the insertion portion of medical endoscopes and certain endoscopic accessories, using either millimetre indication or French size indication.
Optics and optical instruments -- Medical endoscopes and certain accessories -- Part 4: Determination of maximum width of insertion portion
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- 11.040.55
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- 发布
- 2013-09-09
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This part of ISO 8600 specifies a test method for determining the optical resolution of endoscopes for type testing. It is applicable to rigid endoscopes with optics designed for use in the practice of medicine for type testing. It is not applicable to endoscopes having a fibre-optic or opto-electronic imaging system.
Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
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- 11.040.55
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- 发布
- 2013-09-09
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This part of ISO 8600 specifies requirements and recommends test methods for measuring the field of view and direction of view of 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
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- 11.040.55
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- 发布
- 2013-09-09
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Medical electrical equipment -- Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
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- 11.040.55
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- C43
- 发布
- 2013-09-01
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IEC/TS 62791: Ultrasonics - Pulse-echo scanners - Low-echo sphere phantoms and methods for performance testing of gray-scale medical ultrasound scanners applicable to a broad range of transducer types
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- 11.040.55
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- N77
- 发布
- 2013-09
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Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygnomanometers
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- 11.040.55
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- C38
- 发布
- 2013-07
- 实施
This part of ISO 81060 specifies the requirements and methods for the CLINICAL INVESTIGATION of 73 ME EQUIPMENT used for the intermittent non-invasive automated estimation of the arterial BLOOD PRESSURE by 74 utilizing a CUFF. 75This part of ISO 81060 is
Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type
- ICS
- 11.040.55
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- 发布
- 2013-06-06
- 实施
- 2013-06-06
Non-invasive sphygmomanometers. Clinical investigation of automated measurement type
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- 11.040.55
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- C31
- 发布
- 2013-04-30
- 实施
- 2013-04-30
Endoscopes. Medical endoscopes and endotherapy devices. General requirements
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- 11.040.55
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- C40
- 发布
- 2013-04-30
- 实施
- 2013-04-30
Establishes requirements for the declaration of the acoustic output information: 1.to be presented in technical data sheets supplied to prospective purchasers of equipment by manufacturers; 2.to be declared in the accompanying literature/ manual supplied
Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2013-04-27
- 实施
- 2013-04-27
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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- 11.040.55
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- 发布
- 2013-04-23
- 实施
Replace the existing fourth paragraph with the following: The standard does not formulate specific requirements for MR EQUIPMENT or MR SYSTEMS used in 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
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2013-04
- 实施
- 2013-04
