11.040.55 诊断设备 标准查询与下载
共找到 855 条与 诊断设备 相关的标准，共 57 页
本文件规定了全自动诊断型心电仪嵌入式软件的概述、基本要求、测试方法、系统验收以及安全设计。 本文件适用于全自动诊断型心电仪嵌入式软件。
Automatic diagnostic ECG embedded software
- ICS
- 11.040.55
- CCS
- I651
- 发布
- 2023-03-30
- 实施
- 2023-03-30
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
- ICS
- 11.040.55
- CCS
- 发布
- 2023-03-21
- 实施
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
- ICS
- 11.040.55
- CCS
- 发布
- 2023-03-21
- 实施
Endoscopes — Medical endoscopes and endotherapy devices — Part 3: Determination of field of view and direction of view of endoscopes with optics
- ICS
- 11.040.55
- CCS
- 发布
- 2023-03-20
- 实施
本文件规定了临床体温计及其附件的基本安全性和基本性能专用要求。本文件适用于所有用于测量患者体温的电子临床体温计，包括测量和显示体温的医用电气设备。临床体温计可以通过配备接口来包含次级指示器、打印设备和其他辅助设备，从而形成医用电气系统。本文件不适用于辅助设备，也不适用于在室内环境条件下，对人群进行无创发热温度筛查所用的屏幕热像仪。
Medical electrical equipment Part 2-56: Specific requirements for basic safety and essential performance of clinical thermometers used for temperature measurement
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2023-03-14
- 实施
- 2026-05-01
201.1 Scope, object and related standards Clause 1 of the general standard 2 applies, except as follows: 201.1.1 * Scope Replacement: This part of IEC 80601 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 . NOTE 101 A screening thermograph is intended for screening of a human subject and detection of skin temperature elevated above normal. An elevated skin temperature needs to be followed up by a subsequent temperature measurement using a clinical thermometer (see ISO 80601‑2‑56[30]). NOTE 102 The main part of such equipment is commonly referred to as an infrared camera. If a clause ...
Medical electrical equipment - Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
- ICS
- 11.040.55
- CCS
- 发布
- 2023-02-28
- 实施
- 2023-02-28
Medical electrical equipment — Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening — Amendment 1
- ICS
- 11.040.55
- CCS
- 发布
- 2023-01-19
- 实施
Amendment 1 - Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
- ICS
- 11.040.55
- CCS
- 发布
- 2023-01-18
- 实施
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
- ICS
- 11.040.55
- CCS
- 发布
- 2023-01-18
- 实施
本文件规定了多参数患者监护仪的基本安全和基本性能要求。本文件适用于预期连接到单一患者、具有两个或多个生理监护单元的多参数患者监护仪，其预期在专业医疗机构内使用，以及在紧急医疗服务环境或家庭护理环境内使用。本文件不适用于多参数患者监护仪的植入式部分。本文件未规定单独生理监护单元的要求，如心电图（ECG）、有创压和脉搏血氧，其要求在相关专用标准中以独立式医用电气设备的角度有所规定。
Medical electrical equipment Part 2-49: Specific requirements for basic safety and basic performance of multi-parameter patient monitors
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2023-01-13
- 实施
- 2026-01-15
本文件规定了正电子发射断层成像及磁共振成像设备（包含正电子发射断层成像及磁共振成像系统，以下简称PET/MR）的术语、定义、要求和试验方法。本文件适用于可顺序扫描或同步扫描的分体式PET/MR或一体式PET/MR。
General technical requirements for positron emission tomography and magnetic resonance imaging equipment
- ICS
- 11.040.55
- CCS
- C43
- 发布
- 2023-01-13
- 实施
- 2026-01-15
This document specifies a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories.
Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of maximum width of insertion portion
- ICS
- 11.040.55
- CCS
- 发布
- 2023-01-10
- 实施
- 2023-01
Medical electrical equipment — Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
- ICS
- 11.040.55
- CCS
- 发布
- 2022-12-28
- 实施
BS EN IEC 60601-2-34 AMD1. Medical electrical equipment - Part 2-34. Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2022-12-23
- 实施
- 2022-12-23
BS EN 80601-2-49 AMD 1. Medical electrical equipment - Part 2-49.Particular requirements for the basic safety and essential performance of multifunction patient monitors
- ICS
- 11.040.55
- CCS
- 发布
- 2022-12-23
- 实施
- 2022-12-23
本文件规定了一次性使用采样管及保存液的术语和定义、结构形式和材料、要求、检验方法、标签、说明书和包装。 本文件适用于将一次性使用采样器中病毒的洗脱、转运及保存的采样管及保存液。
Technical requirements for disposable sampling tubes and preservation solutions
- ICS
- 11.040.55
- CCS
- C2770
- 发布
- 2022-11-15
- 实施
- 2022-11-23
The scope of the Amendment is the same as EN 61010-2-101:2017. It applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2022-11-11
- 实施
- 2023-03-26 (7)
NEW! IEC 61010-2-101:2018 is available as IEC 61010-2-101:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - adaptation of changes introduced by Amendment 1 of IEC 61010-1; - added tolerance for stability of AC voltage test equipment to Clause 6. This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2022-11-11
- 实施
- 2023-03-26 (7)
本标准包含了技术要求、试验原理、试验方法、检验规则、标识、包装、运输和贮存等内容，对产品安全性、有效性作出更全面系统的评价，统一技术参数。标准将试验用模拟血液样本作为质控物，测定血样开始运作至第一块可检测得到的血凝块形成所需的反应时间（R）、血凝块的形成时间（K）、血凝块逐渐形成的动力特性值（ANG）和最大振幅（MA），准确性范围优于或等同国外同类型产品。
Thromboelastography
- ICS
- 11.040.55
- CCS
- C358
- 发布
- 2022-11-01
- 实施
- 2022-11-09
本文件规定了数字化医用X射线诊断车的基本要求、技术要求、试验方法、检验规则、标志、包装、运输和贮存。
Digital medical X-ray diagnostic vehicle
- ICS
- 11.040.55
- CCS
- C358
- 发布
- 2022-10-27
- 实施
- 2022-10-28
