项目说明

标准编号

标准名称

电气安全通用标准

GB 9706.1-2020

医用电气设备 第1部分：基本安全和基本性能的通用要求

YY/T 9706.106-2021

医用电气设备 第1-6部分：基本安全和基本性能的通用要求 并列标准：可用性

YY 9706.111-2021

医用电气设备 第1-11部分：基本安全和基本性能的通用要求--并列标准：在家庭护理环境中使用的医用电气设备和医用电气系统的要求

GB/T 14710-2009

医用电器环境要求及试验方法

EMC

YY 9706.102-2021

医用电气设备 第1-2部分：基本安全和基本性能的通用要求 并列标准：电磁兼容 要求和试验

电气安全专用标准

YY 9706.210-2021

医用电气设备 第2-10部分：神经和肌肉刺激器的基本安全和基本性能专用要求

YY 9706.240-2021

医用电气设备 第2-40部分：肌电及诱发反应设备的基本安全和基本性能专用要求

YY/T 0696-2021

神经和肌肉刺激器输出特性的测量

YY 0649-2016

电位治疗仪

YY 0868-2021

神经和肌肉刺激用电极

生物学评价

GB/T 16886.1-2022

医疗器械生物学评价 第1部分：风险管理过程中的评价与试验

GB/T 16886.5-2017

医疗器械生物学评价 第5部分：体外细胞毒性试验

GB/T 16886.10-2024

医疗器械生物学评价 第10部分：皮肤致敏试验

GB/T 16886.23-2023

医疗器械生物学评价 第23部分：刺激试验

包装运输

GB/T 4857.5-1992

包装 运输包装件 跌落试验方法

GB/T 4857.4-2008

包装 运输包装件基本试验 第4部分：采用压力试验机进行的抗压和堆码试验方法

GB/T 4857.7-2005

包装 运输包装件基本试验 第7部分:正弦定频振动试验方法

清洗消毒

验证

WS 310系列标准

医院消毒供应中心系列标准

WS/T 367

医疗机构消毒技术规范

YY/T 1495-2016

清洗消毒效果的微生物验证方法

YY/T 0802.2-2024

医疗器械的处理 医疗器械制造商提供的信息 第2部分：低度危险性医疗器械

软件

YY/T 0664

医疗器械软件软件生存周期过程

项目说明

标准编号

标准名称

电气安全及性能标准

IEC 60601-1: 2005 + A1: 2012 + A2: 2020

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-6: 2010 + A1: 2013 + A2: 2020

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-1-11:2015+AMD1:2020

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-2-10:1987/A1:2001

Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC 60601-2-40：2016

Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

EMC

IEC 60601-1-2: 2014 + A1: 2020

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

生物学评价

ISO 10993-1:2025

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

ISO 10993-5:2009

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2021

Biological evaluation of medical devices — Part 10: Tests for skin sensitization

ISO 10993-23:2021

Biological evaluation of medical devices — Part 23: Tests for irritation

包装运输

ASTM D 4169

Standard Practice for Performance Testing of Shipping Containers and Systems

清洗消毒

验证

ANSI/AAMI ST98:2022

Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices

ASTM F3208-20

Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

AAMI TIR 12-2020

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

ISO 17664-1:2021

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices Part 1: Critical and semi-critical medical devices

ISO 17664-2:2021

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices Part 2: Non-critical medical devices

软件

IEC 62304:2006+A1:2015

Medical device software - Software life cycle processes