11.040.55 诊断设备 标准查询与下载

GB 11243-2000 医用电气设备 第2部分 婴儿培养箱安全专用要求

除下列条文外，GB 9706.1的该章适用。 适用范围补充： 本标准规定了本标准中2.1.101所定义的培养箱的安全要求。 本标准不适用于供运输婴儿用的运输用培养箱。 注：对于运输用培养箱见IEC 60601-2-20。

Medical electrical equipment Particular requirements for safety of baby incubators

GSO IEC 80601-2-59:2024 医用电气设备 第2-59部分：人体发热体温筛查用筛查热像仪基本安全和基本性能的特殊要求

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

IEC 80601-2-26:2019/Amd 1:2024 医用电气设备第2-26部分:脑电图仪基本安全和基本性能的特殊要求修改1

Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs — Amendment 1

T/CSBME 070-2023 计算机断层成像（CT）临床图像质量评价

本文件规定了人体中头颅、颈部、胸部、腹部、脊柱及四肢等不同部位不同厂商16排及以上CT临床图像质量评价标准，适用于各种CT机型。

Clinical Image Quality Evaluation of Computed Tomography

T/CSBME 072-2023 车载医用X射线计算机体层摄影设备 临床质量控制要求

本文件规定了车载 CT 临床应用中的质量控制要求。

Clinical Quality Control Requirements for mobile medical X-ray computed tomography (CT) devices

T/CSBME 071-2023 车载医用X射线计算机体层摄影设备临床应用要求

本文件规定了车载CT诊断设备在急性传染性肺炎等重大疫情期间、应急医疗状态以及临床常态化检查应用规范。

Clinical Application Requirements for mobile medical X-ray computed tomography (CT) devices

KS C IEC 60601-2-23-2023 医用电气设备第2-23部分:经皮局部压力监测设备的基本安全和基本性能的特殊要求

Medical electrical equipment — Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

KS C IEC 60601-2-34-2023 医用电气设备第2-34部分:有创血压监测设备的基本安全和基本性能的特殊要求

Medical electrical equipment — Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

T/ZAMEI 0002-2023 X射线计算机体层摄影设备维修维护服务规范

针对为CT扫描装置的安装移机、故障维修、维护保养、质量控制以及技术支持的服务单位各个环节提出规范性服务要求。

X-ray equipment for computed tomography maintenance service specification

T/ZJDAIR 001-2023 α1-微球蛋白测定试剂盒(免疫比浊法)

主要规定了范围、规范性引用文件、术语及定义、要求、试验方法、包装、运输和贮存。

α1-Microglobulin Testing Kit(Immune turbidity Method)

T/ZJDAIR 002-2023 甘胆酸测定试剂盒（免疫比浊法）

主要规定了范围、规范性引用文件、术语及定义、要求、试验方法、包装、运输和贮存。

Cholyglycine test reagent kit(Immune turbidity Method)

T/GDKJ 0038-2023 动态心电记录仪

本文件规定了动态心电记录仪的术语和定义、组成和使用环境、技术要求、试验方法、检验规则、标志、包装、运输、贮存。

Dynamic electrocardiograph recorder

T/HEBQIA 188-2023 脂蛋白磷脂酶A2检测试剂盒 （免疫比浊法）

本文件规定了脂蛋白磷脂酶A2检测试剂盒（免疫比浊法）的原理、组成、技术要求、试验方法、标志、标签、使用说明书、包装、运输和贮存等。

Lipoprotein phospholipase A2 detection kit (immunoturbidimetric method)

T/CASME 562-2023 注射液无菌均质化生产装置

本文件规定了注射液无菌均质化生产装置的产品信息、性能要求、试验方法、检验规则、安装与装配、标志、包装、运输与贮存。

Aseptic homogenization equipment for injection

BS ISO 6028:2023 医疗保健组织管理 大流行应对 自我症状检查应用程序的功能要求

1   Scope This document specifies functional requirements for a self-initiated disease symptom checker app to be used for early screening and control of pandemics such as COVID-19. There are four functional components specified in this document: a) self-registration (see 7.2); b) symptom checking (see 7.3); c) guidance on screening stations (see 7.4); d) health consultation (see 7.5).

Healthcare organization management. Pandemic response. Functional requirements for self-symptom checker app

IEC/CD 60601-2-23:2023 医用电气设备第2-23部分：经皮分压监测

Medical electrical equipment — Part 2-23: Transcutaneous partial pressure monitoring

ISO/CD 12487:2023 医用电气设备 体温计临床调查

Medical electrical equipment — Clinical investigation of clinical thermometers

ISO 6028:2023 医疗机构管理 流行病应对 自我症状检查应用程序的功能要求

This document specifies functional requirements for a self-initiated disease symptom checker app to be used for early screening and control of pandemics such as COVID-19. There are four functional components specified in this document: a) self-registration (see 7.2); b) symptom checking (see 7.3); c) guidance on screening stations (see 7.4); d) health consultation (see 7.5).

Healthcare organization management — Pandemic response — Functional requirements for self-symptom checker app

T/ZAMEI 0001-2023 医用内窥镜维修服务规范

本文件提出医用内窥镜维修的基本要求、维修服务流程和维修服务质量管理。

Medical Endoscope Repair Service Specifications

T/CASME 391-2023 一次性使用病毒采样管（灭活型）

本文件规定了一次性使用病毒采样管（灭活型）的术语和定义、结构和材料、要求、试验方法、检验规则、标签、说明书和包装。

Disposable virus sampling tube (inactivated)