11.040.55 诊断设备 标准查询与下载
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What is BS EN IEC 63077 - Refurbishment for imaging equipment about? BS EN IEC 63077 discusses good refurbishment practices for medical imaging equipment. BS EN IEC 63077 describes and defines the process of refurbishment of used medical imaging equipment and applies to the restoring of used medical imaging equipment to a condition of safety and performance comparable to that of new medical imaging equipment i.e., medical imaging equipment that was not in use. This restoration includes actions such as repair, rework, software/hardware updates, and the replacement of worn parts with original parts. BS EN IEC 63077 enumerates the actions, that are performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the refurbishment of medical imaging equipment is done without changing the finished medical imaging equipment’s performance, safety specifications, or intended use according to its original or applicable valid registration. The medical imaging equipment and systems covered by BS EN IEC 63077 include:
Good refurbishment practices for medical imaging equipment
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- 11.040.55
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- 发布
- 2020-01-31
- 实施
- 2020-01-31
This document specifies the general requirements for basic safety and essential performance of electric radial pulse tonometric devices. This document does not apply to the accuracy of differential diagnosis or interpretation of the diagnostic data obtained from the use of such devices. This document applies to pressure-based radial pulse tonometric devices.
Traditional Chinese medicine — General requirements of electric radial pulse tonometric devices
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- 11.040.55
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- 2020-01-06
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IEC 63077:2019 describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING EQUIPMENT’s performance, safety specifications, or INTENDED USE according to its original or applicable valid registration. The MEDICAL IMAGING EQUIPMENT and systems covered by this document include: – X-RAY EQUIPMENT; – X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES; – X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY; – MAGNETIC RESONANCE EQUIPMENT; – ULTRASONIC DIAGNOSTIC EQUIPMENT; – GAMMA CAMERAS; – PLANAR WHOLEBODY IMAGING EQUIPMENT; – equipment for SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT); – SPECT/CT hybrid systems, combining a GAMMA CAMERA with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); – POSITRON EMISSION TOMOGRAPHS (PET); – PET/CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); – PET/MRI hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETIC RESONANCE EQUIPMENT: and – other combinations of the MEDICAL IMAGING EQUIPMENT or systems listed above. This document does not apply to endoscopic equipment, funduscopic equipment, radiation therapy equipment, nor associated systems. IEC 63077:2019 includes the following significant technical changes with respect to IEC PAS 63077:2016: a) the scope was delineated more clearly; b) an informative cross reference list of IEC 63077 vs ISO 13485 (Annex A) was added; c) smaller corrections were performed.
Good refurbishment practices for medical imaging equipment
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- 11.040.55
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- 发布
- 2019-12-20
- 实施
- 2020-03-18 (7)
Traditional Chinese medicine — General requirements of electric radial pulse tonometric device
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- 11.040.55
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- 发布
- 2019-11-25
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Medical electrical equipment — Medical image display systems — Part 1: Evaluation methods
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- 11.040.55
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- 发布
- 2019-11-25
- 实施
Traditional Chinese medicine — General requirements of electric radial pulse tonometric device
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- 11.040.55
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- 发布
- 2019-11-25
- 实施
Medical electrical equipment — Medical image display systems — Part 1: Evaluation methods
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- 11.040.55
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- 发布
- 2019-11-25
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Good refurbishment practices for medical imaging equipment
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- 11.040.55
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- 发布
- 2019-11-13
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What is BS EN IEC 80601 ‑ 2 ‑ 49 - Multifunction patient monitoring equipment about? BS EN IEC 80601 discusses medical electrical equipment. BS EN IEC 80601 ‑ 2 ‑ 49 applies to basic safety and essential performance requirements of multifunction patient monitors as defined in 201.3.201, hereafter referred to as ME equipment or medical electrical systems. BS EN IEC 80601 ‑ 2 ‑ 49 helps in standardising basic safety and essential performance requirements for multifunction patient monitors as defined in 201.3.201. BS EN IEC 80601 ‑
Medical electrical equipment - Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
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- 11.040.55
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- 发布
- 2019-10-31
- 实施
- 2019-10-31
IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment. The scope of this document is restricted to ME equipment or medical electrical systems intended for connection to a single patient that has two or more physiological monitoring units. For purposes of this document, a pregnant mother and her fetus(es) are considered a single patient. This document does not specify requirements for individual physiological monitoring units such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological monitoring units specify requirements from the perspective of stand-alone ME equipment. This particular standard addresses the additional requirements related to multifunction patient monitors. Multifunction patient monitors can be integrated into other ME equipment or medical electrical systems. When this is the case, other relevant standards also apply. This document does not apply to implantable parts of multifunction patient monitors. This first edition cancels and replaces the second edition of IEC 60601-2-49, published in 2011. This edition constitutes a technical revision to align with the current edition and Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto. Major changes are in Clause 208 because many of the former requirements are now addressed by IEC 60601-1-8.
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
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- 11.040.55
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- 发布
- 2019-10-11
- 实施
- 2019-11-07 (7)
IEC 80601-2-59:2017 applies to the basic safety and essential performance of screening thermographs intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME equipment. This document sets laboratory characterization test limits for the screening thermograph. This edition includes the following significant technical changes with respect to the previous edition: a) updates of the normative references and the bibliography; b) expansion of the applicability to pandemic infectious diseases in general.
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
- 2019-10-11
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- 2020-01-11 (7)
本标准规定了免调码便携式血糖仪（以下简称血糖仪） 的术语和定义、基本要求、技术要求、试验方法、检验规则、标签、使用说明、包装、运输和贮存以及质量承诺。 本标准适用于体外监测人体毛细管全血和/或静脉全血中葡萄糖浓度的便于携带的免调码血糖监测仪器（通常包括血糖仪、一次性试条和质控物质）。
Portable blood glucose meter with auto-coding
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- C354
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- 2019-10-08
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- 2020-01-03
What is BS EN IEC 60601 ‑ 2 ‑ 28 - X-ray tube assemblies for medical diagnosis about? BS EN IEC 60601 ‑ 2 ‑ 28 is part 2-28 of the multi-series standard that discusses medical electrical equipment. BS EN IEC 60601 ‑ 2 ‑ 28
Medical electrical equipment - 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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- 发布
- 2019-09-30
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- 2019-09-30
IEC 60601-2-28:2010 establishes particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. This second edition cancels and replaces the first edition published in 1993. This edition constitutes a technical revision. The second edition of this particular standard has been prepared to fit IEC 60601-1:2005 (the third edition of IEC 60601-1), which is referred to as the general standard.
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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- 发布
- 2019-09-27
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- 2019-11-07 (7)
What is ISO 8600-3 - Medical endoscopes and Endo-therapy devices about? ISO 8600 discusses medical endoscopes and endotherapy devices. ISO 8600-3 is an international standard that provides for the determination of field and direction of view of endoscopes with optics. ISO 8600-3 applies to endoscopes designed for use in the practice of medicine. ISO 8600-3 is the third part of a multi-part series that specifies measurement requirements and describes two test methods for measuring the field of and direction of view of endoscopes with optics. Under ISO 8600-3 method, A uses the distance from the distal window to calculate the field of view, and method B uses the distance from the entrance pupil. Other test methods can be used if they obtain equivalent results. Who is ISO 8600-3 - Medical endoscopes and Endo-therapy devices f...
Endoscopes. Medical endoscopes and endotherapy devices - 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
- 2019-08-31
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- 2019-08-31
This document applies to endoscopes designed for use in the practice of medicine. It specifies measurement requirements and describes two test methods for measuring the field of view and direction of view of endoscopes. Method A uses the distance from the distal window to calculate the field of view. Method B uses the distance from the entrance pupil. Other test methods can be used if they obtain equivalent results.
Endoscopes — Medical endoscopes and endotherapy devices — 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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- 2019-07-29
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本标准规定了制造商为生物学染色用试剂所提供信息的要求。本标准适用于染料、染色剂、发光试剂和用于生物学染色的其他试剂的生产商、供应商和零售商。在生物染色所有领域中，本标准所规定的制造商提供信息的要求，是获得可参照和可复现结果的先决条件。
In vitro diagnostic medical devices.Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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- 11.040.55
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- C30
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- 2019-07-24
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- 2020-08-01
General technical requirements for intravascular ultrasound diagnostic equipment
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- 11.040.55
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- C41
- 发布
- 2019-07-24
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- 2020-08-01
This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204@ hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities@ the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: ?C phono-photic stimulators; ?C EEG data storage and retrieval; ?C ME EQUIPMENT particularly intended for monitoring during electroconvulsive therapy. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only@ or to ME SYSTEMS only@ the title or 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 follows. The clause or subclause applies to ME EQUIPMENT@ as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM@ the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly. 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. NOTE See also 4.2 of the general standard.
Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
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- 11.040.55
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- 发布
- 2019-05-22
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- 2019-05-22
