11.040.99 其他医疗设备 标准查询与下载

T/NBPIA 007-2021 血液透析器临床性能分类

1、按照根据T/NBPIA 005.1 T/NBPIA 005.2、T/NBPIA 005.3、T/NBPIA 005.5规定的方法测得的血液透析器性能参数，将血液透析器分类为低通量血液透析器、高通量血液透析器、中截留量血液透析器和高截留量血液透析器。 2、低通量透析器是指体外实验时，MWRO大于2.0kDa 且小于等于5.0kDa，MWCO大于10.0kDa且小于等于25.0kDa；临床使用过程表现为超滤系数3、体外实验时，MWRO大于5.0kDa 且小于等于9.0kDa，MWCO大于25.0kDa且小于等于55.0kDa；临床使用过程表现为超滤系数>20mL/(mmHg.hr)、β2微球蛋白清除率>20mL/min、YKL-40清除率4、体外实验时，MWRO大于9.0kDa 且小于等于12.5kDa，MWCO大于55.0kDa且小于等于110.0kDa；临床使用过程表现为超滤系数>20mL/(mmHg.hr)、β2微球蛋白清除率>20mL/min、YKL-40（或具有相似特性和分子量的溶质）清除率≥20mL/min、单次血液透析治疗白蛋白丢失平均20mL/(mmHg.hr)、β2微球蛋白清除率>20mL/min、YKL-40（或具有相似特性和分子量的溶质）清除率>20mL/min、单次血液透析治疗白蛋白丢失平均>4.0g（最大者超过6.7g）的一类血液透析器。

Classification of hemodialyzer clinical performance

DB36/T 1481-2021 经筋手法松解术技术操作规范

Specifications for the technical operation of tendon-manipulative release

DB36/T 1480-2021 热敏灸技术操作规范

Heat-sensitive moxibustion technical operation specification

ISO 18666:2021 中药.艾灸装置的一般要求

This document specifies the general requirements for configuration, materials, performance and safety requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion materials used in moxibustion devices. It is applicable across a wide range of moxibustion devices that use moxa floss as the main combustion material and can remain on or over the body throughout the moxibustion process. It is applicable to moxibustion devices for both single and repeated usage. This document does not apply to devices that imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices that do not involve the use of moxa floss. It also does not apply to moxa floss used in direct moxibustion.

Traditional Chinese medicine — General requirements of moxibustion devices

T/ZZB 2540-2021 电动病床

本文件规定了电动病床的术语和定义、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。 本文件适用于医疗监护下患者的诊断、治疗或监护时使用的电动病床，适用于医院、康复医疗机构等场所。

Electric sickbed

YY 9706.252-2021 医用电气设备 第2-52部分:医用病床的基本安全和基本性能专用要求

Medical electrical equipment Part 2-52: Special requirements for basic safety and basic performance of medical beds

T/SZBX 055-2021 电动产床

本文件规定了电动产床的组成与结构、基本功能、尺寸与参数、要求、试验方法、检验规则和标志、使用说明书、包装、运输、贮存的要求。

Electric birthing beds

T/ZZB 2341-2021 4K医用内窥镜摄像系统

本文件规定了4K医用内窥镜摄像系统的产品组成、工作环境、基本要求、技术要求、试验方法、检验规则、标志、包装、运输和贮存以及质量保证。 本文件适用于内窥镜检查和手术中作为内窥镜功能供给装置且分辨率为（3 840×2160）Pixel或（4096×2 160）Pixel的医用内窥镜摄像系统。 本文件不适用于特殊光谱作用和非可见光谱成像的摄像系统。

4K medical endoscopes video camera system

T/GDMDMA 0006-2021 医用内窥镜 内窥镜功能供给装置 近红外荧光摄像系统

可拆卸镜头的要求（调制传递函数、焦距）、亮度响应特性、信噪比、空间频率响应、静态图像宽容度、荧光图像分辨率、荧光灵敏度、荧光穿透深度、电气安全。

Medical endoscopes—Endoscope supply units—Near infrared fluorescence video camera system

T/GDMDMA 0005-2021 医用内窥镜 内窥镜功能供给装置 含有近红外激发光的冷光源

构成、光谱性能（显色指数、相关色温、红绿蓝光的辐通量比、近红外激发光的光谱特征、红外截止性能）、参考窗口的光照均匀性能（光照均匀性、照度超限点）、辐射性能（输出总光通量）、激发光功率、激发光输出功率的复现性、激发光输出功率的不稳定度、电气安全、机械接口规格、防故障的安全措施。

Medical endoscopes—Endoscope supply units—Cold light sources contained near infrared excitation light

GSO ISO 18665:2021 中医—中药煎药器

ISO 18665.2015 specifies the general requirements of herbal decoction apparatus with design pressures less than 0,1MPa. It includes both hermetic and non-hermetic decoction apparatus. It is applicable to the herbal decoction apparatus for individual herbal formula prescriptions and for commercial use as well as private use. It also applies to the decocting part of the integrated apparatus of decoction and package.

Traditional Chinese medicine — Herbal decoction apparatus

GSO ISO 20308:2021 中医 刮痧器具

ISO20308:2017 specifies appearance, material, requirements of visual inspection, cleaning and disinfection, hardness, roughness, resistance to abrasion, exposure index of radionuclide activity, biocompatibility of Gua Sha instruments, as well as related information on package, transport and storage, labelling and instructions for use. Electro-devices and other forms are outside the scope of this document.

Traditional Chinese medicine — Gua Sha instruments

GSO 2629:2021 拔罐器的安全使用和处理

This document specifies requirements of safety controls of cupping devices used for air suction or discharge and contains cups made of manufactured materials such as plastic, glass, rubber, ceramic or silicone. It is not applied to cupping devices that contain cups made from natural materials (e.g. bamboo) or those that include additional features like magnetic, infrared or others.

Safe Use and Handling of Cupping Devices

GSO ISO 21366:2021 中医无烟艾灸器通用要求

This document specifies general requirements to ensure the performance and safety of smokeless moxibustion devices. It covers smoke density, moxibustion temperature, noxious gas and test methods for smokeless moxibustion devices. This document is applicable to any combustion-type device that claims to provide smokeless moxibustion. This document does not apply to devices that imitate moxibustion, such as electro moxibustion and infrared moxibustion devices.

Traditional Chinese medicine — General requirements for smokeless moxibustion devices

GSO ISO 18666:2021 中医艾灸器具通用要求

ISO 18666:2015 specifies the general requirements for configuration, materials, performance and safety requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion materials used in moxibustion devices. It is applicable across a wide range of moxibustion devices that uses moxa floss as the main combustion material and can remain on or over the body throughout the moxibustion process. It is applicable to moxibustion devices for both single and repeated usage. ISO 18666:2015 does not apply to devices that imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices that do not involve the use of moxa floss. It also does not apply to moxa floss used in direct moxibustion.

Traditional Chinese medicine — General requirements of moxibustion devices

GSO ASTM F2528:2021 带保留球囊的肠内喂养装置的标准测试方法

These test methods cover the establishment of performance requirements for the utilization of a single-use, enteral feeding device with a retention balloon, used by medical professionals for providing a means of nutrition and/or administration of medication to patients by means of natural orifice (nasal, oral, transluminal) and or a surgically created stoma. The product is manufactured in various sizes and materials such as silicone, urethane, and various polymers (as well as combinations of these) and is provided nonsterile for sterilization and sterile for single use only. The following test methods are: Flow rate through feeding lumen test method which covers the determination of flow rates through the drainage lumen of the enteral feeding device with retention balloon, balloon burst volume test method which covers the determination of balloon integrity of enteral feeding devices with retention balloon, balloon volume maintenance test method which is applicable enteral feeding devices with retention balloon to test the integrity of the inflation system to maintain balloon volume, balloon concentricity test method which is applicable enteral feeding devices with retention balloon to test the concentricy of the balloon, balloon size and shaft size test method which evaluates the retention balloon shaft size, balloon integrity test method which evaluates the integrtity of the retention balloon of the enteral feeding device, and balloon integrity in simulated gastric fluid test method which assesses the ability of the retention balloon to withstand gastric acidity levels without rupture, therefore, maintaining its functional purpose of retention.

Standard Test Methods for Enteral Feeding Devices with a Retention Balloon

GSO ISO 20498-1:2021 中医学 计算机化舌象分析系统 第1部分：通用要求

This document specifies general requirements for a computerized tongue image analysis system (CTIS). This document is limited to the safety aspects and technical requirements for a CTIS, excluding the diagnosis or interpretation of tongue images.

Traditional Chinese medicine — Computerized tongue image analysis system — Part 1: General requirements

GSO ISO 23907-2:2021 锐器伤害防护 要求和测试方法 第2部分：可重复使用的锐器容器

This document specifies requirements for reusable sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars, hypodermic needles and syringes. This document is applicable to sharps containers that are supplied complete by the manufacturer and to those that are supplied as components intended to be assembled by the user. It is not applicable to single use sharps containers (refer to ISO 23907-1 for such containers). This document includes design functionality for user safety, lifespan simulation, cleaning and decontamination, microbiological validation, quality monitoring and performance testing.

Sharps injury protection — Requirements and test methods — Part 2: Reusable sharps containers

GSO ISO/TR 20498-5:2021 中医学 计算机化舌象分析系统 第5部分：舌色、舌苔颜色的获取与表达方法

This document describes a method of acquisition of tongue image and expression of tongue colour and coating colour by computerized tongue image analysis system (CTIS). This document does not cover the clinical tongue diagnosis result.

Traditional Chinese medicine — Computerized tongue image analysis system — Part 5: Method of acquisition and expression of tongue colour and tongue coating colour

GSO 2680:2021 清真医疗器械 一般要求

This Standard specifies the requirements in the manufacturing and handling of particular medical devices for the purpose of halal certification.

Halal medical device – General requirements