11.040.99 其他医疗设备 标准查询与下载

MZ/T 156-2020 低视力康复服务规范

Low vision rehabilitation service specifications

MZ/T 161-2020 电动卫浴护理椅

Electric bathroom nursing chair

ISO/TS 20498-4:2020 中医 - 电脑舌图像分析系统 - 第4部分:外围视觉仪器

Traditional Chinese medicine — Computerized tongue image analysis system — Part 4: Peripheral visual instruments

ISO 21292:2020 中药电热灸设备

This document specifies general requirements for electrical heating moxibustion equipment. It is not applicable to infrared moxibustion equipment covered by ISO 20493 and smokeless moxibustion devices covered by ISO 21366.

Traditional Chinese medicine — Electric heating moxibustion equipment

T/SZAS 19-2020 游离DNA保存管

本标准规定了游离DNA保存管（或称游离DNA采血管）的产品要求和试验方法。 本标准适用于游离DNA相关研究及实验的血液采集（如NIPT）以及游离DNA保存管制造商和通过保存人体静脉血样提取游离DNA进行相关检测的生物检测机构。

Cell-free DNA collection tube

ISO/TS 20498-3:2020 中医 - 电脑舌图像分析系统 - 第3部分:色彩图

Traditional Chinese medicine — Computerized tongue image analysis system — Part 3: Colour chart

T/NAHIEM 18-2019 纯水电解吸氢机

本标准规定了纯水电解吸氢机（以下简称“吸氢机”）的术语和定义、产品分类、技术要求、试验方法、检验规则、标志、包装、运输和贮存。 本标准适用于吸氢机，该吸氢机可生产出供人呼吸的氢气。

PureWaterElectrolytic Hydrogen Inhalation Machine

BS ISO 23907-2:2019 锐器伤害防护 要求和测试方法 可重复使用的锐器容器

What is ISO 23907-2- Reusable sharps containers for sharps injury protection about? ISO 23907 discusses sharps injury protection. ISO 23907-2 is an international standard that provides for reusable sharps containers for sharps injury protection. ISO 23907-2 is the second part of a multi-part series that outlines 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. ISO 23907-2 applies to sharps containers that are supplied completely by the manufacturer and to those that are supplied as components intended to be assembled by the user. ISO 23907-2 includes design functionality for user safety, lifespan simulation, cleaning and decontamination, microbiological validation, quality monitoring, and performance testing. Note 1: ISO 2390-7 does not apply to single-use sharps containers. Note 2: Sharps containers can be either single-use or reusable. Who is ISO 23907-2- Reusable sharps containers for sharps injury protection for? ISO 23907-2 on reusable sharps containers for sharps injury protection is useful for: Reusable sharps containers manufacturers Test centers for reusable sharps containers Regulatory authorities Why should you use ISO 23907-2- Reusable sharp...

Sharps injury protection. Requirements and test methods - Reusable sharps containers

KS P 2048-2019 计算机舌象采集系统通用要求

Computerized tongue image acquisition system — General requirements

KS P ISO 21366-2019 中药无烟灸器通用要求

Traditional Chinese medicine ― General requirements for smokeless moxibustion devices

KS P ISO 21366:2019 中药无烟灸器通用要求

Traditional Chinese medicine ― General requirements for smokeless moxibustion devices

ISO 23907-2:2019 剃须刀伤害保护 - 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

T/CSBME 009-2019 医疗器械网络安全质量评价方法

本标准的目的是对处于网络环境中的医疗器械产品（包含软件和硬件）从网络安全的角度如何进行评估和考量。本标准从术语及定义、技术要求（随附文件、产品设计要求、产品功能要求）、符合性评价细则（随附文件符合性评价、产品设计要求符合性评价、产品功能要求符合性评价）等方面做出了相关规定。

Quality Evaluation Method of Cybersecurity in Medical Devices

T/LEECH 006-2019 一次性医用水蛭质量要求

规定了一次性医用水蛭的术语和定义、技术要求、检验规则、标志、标签、包装、运输、存储和处置

Quality requirements of disposable medical leeches

T/CAME 5-2019 磁共振引导放射治疗系统检测体模技术规范

1.范围，2.规范性引用文件，3.术语和定义，4.体模概述，5.体模的技术要求，6.体模随机文件，7.体模检测，附录A（规范性附录）多线圈一致性信噪比体模技术要求的说明，附录B（规范性附录）关于大孔径几何畸变检测体模技术要求及检测的说明。

Specification and technical requirements for quality control phantom on MRI guided radiation therapy

EN IEC 60601-2-39:2019 医用电气设备 第 2-39 部分：腹膜透析设备基本安全和基本性能的特殊要求

NEW! IEC 60601-2-39:2018 is available as IEC 60601-2-39:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-39:2018 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This third edition cancels and replaces the second edition of IEC 60601-2-39. It constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition: - update of the references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 and of references and requirements to IEC 60601-1-11:2015; - editorial improvements; - improvement of the essential performance requirements clause/subclauses; - new requirements for the interruption of the power supply.

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

ISO 21366:2019 中药 - 无烟艾灸的一般要求

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

ISO 20498-1:2019 中医 - 电脑舌像分析系统 - 第1部分:一般要求

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

BS EN ISO 23907-1:2019 锐器伤害防护 要求和测试方法 一次性锐器容器

What is ISO 23907-1- Single-use sharps containers for sharps injury protection about? ISO 23907 discusses sharps injury protection. ISO 23907-1 is an international standard that provides for single-use sharps containers for sharps injury protection. ISO 23907-1 is the first part of a multi-part series that layouts requirements for single-use sharps containers that are intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g., scalpel blades, trocars, hypodermic needles, and syringes. ISO 23907-1 plan for the safe handling and disposal of needles before use. ISO 23907-1 applies to single-use sharps containers that are supplied completely by the manufacturer and to those that are supplied as components intended to be assembled by the user. Note: ISO 23907-1 does not apply to reusable sharps containers or the outer containers used in the transportation of filled single-use sharps containers. Who is ISO 23907-1- Single-use sharps containers for sharps injury protection for? ISO 23907-1 on single-use sharps container for sharps injury protection is useful for: Single-use s...

Sharps injury protection. Requirements and test methods. Single-use sharps containers

ISO 23907-1:2019 剃须刀伤害保护 - 要求和测试方法 - 第1部分:一次性使用的锐器容器

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