11.040.55 诊断设备 标准查询与下载

T/CSBME 027-2021 肌酸激酶同工酶（CKMB）定量测定试剂（盒） （荧光免疫层析法）

本文件规定了肌酸激酶同工酶（CKMB）定量测定试剂（盒）（荧光免疫层析法）的技术要求、试验方法、标志包装、运输和贮存。

Creatin Kinase Isoenzyme (CKMB) Quantitative Assay（kit） (fluorescence immunochromatography)

T/CSBME 035-2021 磁共振成像系统可靠性设计规范

本文件规定了磁共振成像系统（以下简称“MR系统”）的可靠性设计基本流程和方法。

Specification for reliability design of Nuclear Magnetic Resonance Imaging system

T/CSBME 028-2021 心肌肌钙蛋白Ⅰ定量测定试剂（盒）（荧光免疫层析法）

本文件规定了心肌肌钙蛋白I定量测定试剂（盒）（荧光免疫层析法）的技术要求、试验方法、标志、包装、运输和贮存。

Cardiac troponin-I quantitative Assay (kit) (fluorescence immunochromatography)

T/CSBME 026-2021 肌红蛋白定量测定试剂（盒） （荧光免疫层析法）

本文件规定了肌红蛋白定量测定试剂（盒）（荧光免疫层析法）的技术要求、试验方法、标志、包装、运输和贮存。

Myoglobin Quantitative Assay （Kit） (fluorescence immunochromatography)

T/CSBME 031-2021 经食管超声探头消毒及存储规范

本文件规定了经食管超声探头的消毒及存储规范。

Specification for disinfection and storage of transesophageal echocardiography probe

GOST R 59731-2021 医疗电气设备 磁共振断层扫描仪 技术状态控制方法

Medical electrical equipment. Magnetic resonance tomographs. Technical condition control methods

GOST R 59448-2021 听力计公共采购技术要求

Audiometers.Technical requirements for public procurement

KS C IEC 80601-2-49-2020 多参数病人监护设备委员会电子医疗 病人监护 诊断设备医用电气设备第2-49部分:多功能病人监护机基本安全和基本性能的特殊要求

Medical electrical equipment — Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

KS C IEC 80601-2-49:2020 多参数病人监护设备委员会电子医疗 病人监护 诊断设备医用电气设备第2-49部分:多功能病人监护机基本安全和基本性能的特殊要求

Medical electrical equipment — Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

T/ZZB 1990-2020 一次性使用压力传感器

本文件规定了一次性使用压力传感器的术语和定义、型式和基本参数、基本要求、技术要求、试验方法、检验规则、包装、标志、运输和贮存、质量承诺。 本文件适用于一次性使用压力传感器（以下简称压力传感器）。该产品用于测量人体有创血压，如动脉压、中心静脉压、肺动脉压、心房压等，并能持续地传输有创血压信号。

Disposable blood pressure transducer

T/ZZB 1892-2020 麻醉深度监测仪

本文件规定了麻醉深度监测仪的术语和定义、基本参数和工作条件、基本要求、技术要求、试验方法、检验规则、标志、包装、运输、贮存和质量承诺。 本文件适用于监测镇静药物维持过程中患者脑电波及意识状态的麻醉深度监测仪（以下简称监测仪）。

Anesthesia depth monitor

BS ISO 8600-5:2020 光学和光子学. 医用内窥镜和内疗器件. 刚性光学内窥镜的光学分辨率测定

Optics and photonics. Medical endoscopes and endotherapy devices. Determination of optical resolution of rigid endoscopes with optics

DS/ISO 8600-5:2020 光学与光子学《医用内窥镜和内窥镜治疗装置》第5部分：硬质光学内窥镜光学分辨率的测定

Optics and photonics – Medical endoscopes and endotherapy devices – Part 5: Determination of optical resolution of rigid endoscopes with optics

PN-EN ISO 80601-2-56-2017-10/A1-2020-11 E 医用电气设备 第2-56部分：体温测量用体温计的基本安全和基本性能的特殊要求 修正案1（ISO 80601-2-56:2017/Amd 1:2018）

Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement -- Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018)

ISO 8600-5:2020 内窥镜——医用内窥镜和内治疗设备第7部分:防水型医用内窥镜的基本要求

This document applies to rigid endoscopes designed for use in the practice of medicine. Endoscopes having a fibre-optic or opto-electronic imaging system are excluded. It specifies a test method for determining the optical resolution of endoscopes. This document provides a measurement method for characterizing three aspects of the optical resolution of a rigid endoscope. Characteristic A is used to provide a simple measurement of the limiting resolution of the endoscope image. Characteristic B provides a measurement of low spatial frequency resolution and characterizes the sharpness, or contrast, of the endoscope image. Characteristic C provides a measurement of the spatial frequency response of the endoscope image.

Endoscopes — Medical endoscopes and endotherapy devices — Part 7: Basic requirements for medical endoscopes of water-resistant type

SN EN ISO 80601-2-56/A1:2020 医用电气设备 第 2-56 部分：用于体温测量的临床温度计的基本安全和基本性能的特殊要求（ISO 80601-2-56:2017/Amd 1:2018）；修正案 A1

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017/Amd 1:2018); Amendment A1

BS ISO 18340:2020 内窥镜 套管针、套管针套管和与套管针套管一起使用的内治疗装置

What is ISO 18340 about?    ISO 18340 discusses trocar pins, trocar sleeves, and endo therapy devices for use with trocar sleeves for endoscopes. ISO 18340 outlines the design, testing, and labelling of trocar sleeves and trocar pins that are universally interchangeable and reusable.   ISO 18340 also specifies the design, testing, and labelling of endo therapy devices that are inserted through these trocar sleeves and are also universally interchangeable and reusable.   ISO 18340 specifies the minimum requirements to ...

Endoscopes. Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves

ISO 18340:2020 内窥镜 - 套管针 套管针袖和内套治疗装置 用于套管针袖

This document specifies the design, testing and labelling of trocar sleeves and trocar pins that are universally interchangeable and reusable. It also specifies the design, testing and labelling of endotherapy devices which are inserted through these trocar sleeves and are also universally interchangeable and reuseable. This document specifies the minimum requirements for the production of the products mentioned.

Endoscopes — Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves

BS EN ISO 80601-2-56:2017+A1:2020 医用电气设备 体温测量用体温计基本安全和基本性能的特殊要求

Medical electrical equipment - Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

EN ISO 80601-2-56:2017/A1:2020 医疗电气设备.2-56部分:特殊要求基本的安全和基本性能的临床温度计体温测量 包含修改件A1,2020

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018)