11.040.55 诊断设备 标准查询与下载
共找到 856 条与 诊断设备 相关的标准，共 58 页
The second edition of IEC 60601-1-8 was published in 2006 and amended in 2012. Since the publication of IEC 60601-1-8:2006/AMD1:2012, the IEC Subcommittee (SC) 62A Secretariat has been collecting issues from a variety of sources including comments from National Committees. At the
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC
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- 11.040.55
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- 发布
- 2021-12-00
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- 2021-12-01
规定了一次性使用病毒采样管的术语和定义、结构形式和材料、要求、检验方法、标签、说明书和包装。
Disposable virus sampling tube
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- 11.040.55
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- C2770
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- 2021-11-16
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- 2021-11-16
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
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- 11.040.55
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- 2021-11-10
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3 术语和定义 3.1 准确度 3.2 临床敏感性 3.3 临床特异性 3.4 符合率 4 机构要求 4.1 布局 4.2 设备设施 4.3 用品用具 4.4 环境 4.5 标志标识 2 4.6 安全 5 准确度 6 人员要求 7 检后管理
Protocol of immune function detection
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- 11.040.55
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- Q849
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- 2021-10-19
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- 2021-10-19
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (IEC 62D/1892/CDV) (Amendment) (english version)
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- 11.040.55
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- 2021-10-15
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- 2021-10-15
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs; Corrigendum 1
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- 11.040.55
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- C39
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- 2021-10-01
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Medical electrical equipment Part 2-34: Specific requirements for basic safety and basic performance of invasive blood pressure monitoring equipment
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- 11.040.55
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- C39
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- 2021-09-06
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- 2024-05-01
Medical electrical equipment Part 2-47: Specific requirements for basic safety and basic performance of ambulatory electrocardiography systems
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- 11.040.55
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- C39
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- 2021-09-06
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- 2024-05-01
Medical electrical equipment Part 2-21: Specific requirements for basic safety and basic performance of infant radiant warming tables
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- 11.040.55
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- C39
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- 2021-09-06
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- 2024-05-01
Medical electrical equipment – Medical image display systems – Part 1: Evaluation methods
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- 11.040.55
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- 发布
- 2021-09-03
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- 2021-09-03
1 Scope 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 image information on greyscale and colour image display systems . 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. Handheld image display systems might require additional or modified versions of the procedures described in this standard. It is not in the scope of this standard to define the requirements of acceptance and constancy tests or the frequencies of constancy tests.
Medical electrical equipment. Medical image display systems - Evaluation methods
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- 11.040.55
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- 发布
- 2021-08-31
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- 2021-08-31
本文件针对红外额温计的产品检测性能、技术要求和安全要求及对应的检测方法等方面制定规范，意在保障红外额温计在市场上的应用可靠性，使检测机构或制造厂商在检验和管控产品质量时有据可依。在研制本文件的过程中，鉴于红外额温计相关技术和多变应用环境的情况，也尽量考虑到用户要求、检测机构和制造厂商等几方面的重点需求，注重本文件的可操作性，在充分体现本文件的技术先进性的同时，也兼顾到经济上的合理性和社会效益，以使本文件为红外额温计的质量管理和市场应用提供帮助。
Infrared forehead thermometers
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- 11.040.55
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- C358
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- 2021-08-20
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- 2021-08-23
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 62B/1247/CDV) (english version)
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- 11.040.55
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- 发布
- 2021-08-15
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- 2021-08-15
Optics and optical instruments－Medical endoscopes and endoscopic accessories－Part 2：Particular requirements for rigid bronchoscopes
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- 11.040.55
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- 发布
- 20210722
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- 20210722
Optics and optical instruments－Medical endoscopes and endoscopic accessories－Part 1：General requirements
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- 11.040.55
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- 发布
- 20210722
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- 20210722
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
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- 11.040.55
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- 发布
- 2021-07-19
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Amendment 2 - Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
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- 11.040.55
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- 发布
- 2021-07-19
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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
- 2021-07-19
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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 monitors
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- 11.040.55
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- 2021-07-01
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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
- 2021-07-01
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