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
- ICS
- 11.040.55
- CCS
- 发布
- 2021-12-00
- 实施
- 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
- ICS
- 11.040.55
- CCS
- C2770
- 发布
- 2021-11-16
- 实施
- 2021-11-16
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
- ICS
- 11.040.55
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- 发布
- 2021-11-10
- 实施
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
- CCS
- Q849
- 发布
- 2021-10-19
- 实施
- 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)
- ICS
- 11.040.55
- CCS
- 发布
- 2021-10-15
- 实施
- 2021-10-15
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs; Corrigendum 1
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2021-10-01
- 实施
Medical electrical equipment Part 2-34: Specific requirements for basic safety and basic performance of invasive blood pressure monitoring equipment
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2021-09-06
- 实施
- 2024-05-01
Medical electrical equipment Part 2-21: Specific requirements for basic safety and basic performance of infant radiant warming tables
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2021-09-06
- 实施
- 2024-05-01
Medical electrical equipment Part 2-47: Specific requirements for basic safety and basic performance of ambulatory electrocardiography systems
- ICS
- 11.040.55
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- C39
- 发布
- 2021-09-06
- 实施
- 2024-05-01
Medical electrical equipment – Medical image display systems – Part 1: Evaluation methods
- ICS
- 11.040.55
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- 发布
- 2021-09-03
- 实施
- 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
- ICS
- 11.040.55
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- 发布
- 2021-08-31
- 实施
- 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
- ICS
- 11.040.55
- CCS
- C358
- 发布
- 2021-08-20
- 实施
- 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)
- ICS
- 11.040.55
- CCS
- 发布
- 2021-08-15
- 实施
- 2021-08-15
Optics and optical instruments－Medical endoscopes and endoscopic accessories－Part 1：General requirements
- ICS
- 11.040.55
- CCS
- 发布
- 20210722
- 实施
- 20210722
Optics and optical instruments－Medical endoscopes and endoscopic accessories－Part 2：Particular requirements for rigid bronchoscopes
- ICS
- 11.040.55
- CCS
- 发布
- 20210722
- 实施
- 20210722
Amendment 2 - Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
- ICS
- 11.040.55
- CCS
- 发布
- 2021-07-19
- 实施
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
- ICS
- 11.040.55
- CCS
- 发布
- 2021-07-19
- 实施
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
- ICS
- 11.040.55
- CCS
- 发布
- 2021-07-19
- 实施
ISO/TS 18339:2015 specifies the design of eyepiece cap and light guide connector of an endoscope to enable the combination of products from different manufacturers. The products intended only for limited combination are out of the scope. It is a mechanical connection; it might not generate best results, but it allows the user to be able to work. ISO/TS 18339:2015 supports manufacturers of components in the design of interfaces.
Endotherapy devices — Eyepiece cap and light guide connector
- ICS
- 11.040.55
- CCS
- 发布
- 2021-07-01
- 实施
ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create me systems. This document does not apply to auxiliary equipment. Me equipment that measures a body temperature is inside the scope of this document. ISO 80601-2-56:2017 does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of groups of individual humans under indoor environmental conditions, which are given in IEC 80601‑2‑59[4]. 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 document are not covered by specific requirements in this document except in IEC 60601‑1:2005+A1:2012, 7.2.13 and 8.4.1. NOTE Additional information can be found in IEC 60601?1:2005+A1:2012, 4.2.
Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ICS
- 11.040.55
- CCS
- 发布
- 2021-07-01
- 实施
