11.040.99 其他医疗设备 标准查询与下载

GSO ISO 19611:2021 中医 抽气拔罐器

ISO 19611:2017 specifies requirements for an air extraction cupping device which operates using negative pressure. This document includes requirements for the material, pressure, sterilization or disinfection, and packaging of the cupping device, as well as appropriate test methods. ISO 19611:2017 is applicable to single-use type and multiple-use type devices. ISO 19611:2017 does not apply to the suction pump used to create the negative pressure.

Traditional Chinese medicine — Air extraction cupping device

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 ISO 23907-1:2021 锐器伤害防护 要求和测试方法 第1部分：一次性使用锐器容器

This document specifies requirements for single-use 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. It is applicable to single-use 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 reusable sharps containers or to the outer containers used in the transportation of filled single-use sharps containers.

Sharps injury protection — Requirements and test methods — Part 1: Single-use sharps containers

T/GDMDMA 0004-2021 医用内窥镜 内窥镜摄像系统可靠性 设计规范

可靠性设计目标、可靠性设计基本原则、可靠性设计工作流程、系统可靠性建模、可靠性分配、可靠性预计、DFMEA分析、FTA分析、系统可靠性设计准则。

Medical endoscopes—Reliability design specification of endoscopic camera system

T/CAME 32-2021 医用气体汇流排

本文件规定了医用气体汇流排(以下简称“汇流排”)的分类、概述、技术要求、试验方法、检验规则、标志、使用说明书、包装、运输和贮存。 本文件适用于进气压力不大于20000kPa的汇流排的设计、生产和检验。 本文件不适用于焊接绝热气瓶江流排。

Medical gas manifold

LST EN ISO 16061:2021 与无源外科植入物结合使用的器械 一般要求（ISO 16061:2021）

Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

T/ZZB 2110-2021 输尿管肾镜

本文件规定了输尿管肾镜的术语和定义、基本要求、技术要求、试验方法、检验规则、标签和随附资料、包装、运输、贮存和质量承诺。 本文件适用于在临床上供输尿管肾镜手术用的输尿管肾镜，不适用于电子输尿管肾镜。

Uretero—Renoscope

T/ZZB 2050-2021 肺功能测定仪

本文件规定了肺功能测定仪的术语和定义、缩略语、结构组成、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。 本文件适用于肺活量参数检测的肺功能测定仪。

Spirometer

GOST 28311-2021 医学实验用定量器 一般技术要求及试验方法

Medical laboratory dosers. General technical requirements and test methods

T/CAMDI 050.1-2020 内窥镜配套使用器械 第1部分 通用要求

本文件规定了与内窥镜配套使用器械的通用要求。 本文件适用于与内窥镜配套使用的器械。 本文件不适用于内窥镜配套使用的有源器械。

Endoscope supporting equipment part 1 general requirements

T/CAMDI 050.2-2020 内窥镜配套使用器械 第2部分：一次性使用内窥镜用注射针

本文件规定了一次性使用内窥镜用注射针（以下简称：内镜针）的要求和试验方法。 本文件适用于与内窥镜配套使用的内镜针。

Endoscope supporting equipment part 2: injection needle for single-use endoscope

MZ/T 158-2020 固定在座便器上的助力扶手

Power-assisted armrests fixed to the toilet

MZ/T 154-2020 假乳房

fake breasts

MZ/T 155-2020 轮椅车用便携式坡道

Portable ramp for wheelchairs

MZ/T 157-2020 手动移位车

Manual shift car

MZ/T 159-2020 顶立式组合助力扶手

Top-standing combination power armrest

MZ/T 153-2020 康复训练器械 平行杠

Rehabilitation training equipment parallel bar

MZ/T 156-2020 低视力康复服务规范

Low vision rehabilitation service specifications

MZ/T 151-2020 康复训练器械 砂磨桌

Rehabilitation training equipment sanding table

MZ/T 160-2020 电动浴缸椅

electric bath chair