电气安全

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

GB 9706.222-2022

医用电气设备 第2-22部分：外科、整形、治疗和诊断用激光设备的基本安全和基本性能专用要求

GB 9706.218-2021

医用电气设备 第2-18部分：内窥镜设备的基本安全和基本性能专用要求

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 9706.108-2021

医用电气设备 第1-8部分：基本安全和基本性能的通用要求 并列标准：通用要求,医用电气设备和医用电气系统中报警系统的测试和指南

GB/T 7247.1-2012

激光产品的安全 第1部分：设备分类、要求

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

性能指标

YY 0846-2011

激光治疗设备 掺钬钇铝石榴石激光治疗机

YY 0307-2022

激光治疗设备 掺钕钇铝石榴石激光治疗机 

YY/T 0758-2021

医用激光光纤通用要求

YY/T 1057-2016

医用脚踏开关通用技术条件

YY/T 0968.1-2014

医用光辐射防护镜 评价方法 第1部分：光辐射危害降低程度

YY/T 0968.2-2014

医用光辐射防护镜 评价方法 第2部分：视明觉和色觉

YY/T 0756-2009

光学和光学仪器 激光和激光相关设备 激光光束功率（能量）密度分布的试验方法

GB 44703-2024

光辐射安全通用要求

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 16886.4-2022

医疗器械生物学评价 第4部分：与血液相互作用试验选择

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 16886.11-2021

医疗器械生物学评价 第11部分：全身毒性试验

GB/T 16886.23-2023

医疗器械生物学评价 第23部分：刺激试验

灭菌过程管理和效果检测

GB 27955-2020

过氧化氢气体等离子体低温灭菌器卫生要求

GB 18278.1-2015

医疗保健产品灭菌 湿热 第 1 部分：医疗器械灭菌过程的开发、确认和常规控制要求

GB 18279-2023

医疗保健产品灭菌 环氧乙烷 医疗器械灭菌过程的开发、确认和常规控制要求

GB 18280.2-2015

医疗保健产品灭菌 辐射 第 2 部分：建立灭菌剂量

GB/T 19974-2018

医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌过程的开发、确认和常规控制的通用要求

GB/T 19973.1-2023

医疗保健产品灭菌 微生物学方法 第 1 部分：产品上微生物总数的确定

GB/T 19973.2-2025

医疗产品灭菌 微生物学方法 第 2 部分：用于灭菌过程的定义、确认和维护的无菌试验

GB/T 16886.7-2015

医疗器械生物学评价 第 7 部分：环氧乙烷灭菌残留量

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 

WS 310系列；WS/T 367

清洗消毒及灭菌技术操作规范

包装运输

GB/T 4857系列

包装 运输包装件基本试验

软件和网络安全

GB/T 25000.10

系统与软件工程 系统与软件质量要求和评价（SQuaRE） 第 10 部分：系统与软件质量模型

GB/T 25000.51

系统与软件工程 系统与软件质量要求和评价（SQuaRE） 第 51 部分：就绪可用软件产品（RUSP）的质量要求和测试细则

YY/T 0664

医疗器械软件 软件生存周期过程

YY/T 1843-2022

医用电气设备 网络安全基本要求

电气安全

IEC 60601-1: 2012

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

IEC 60601-1-6: 2013

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

IEC 60601-2-22:2019

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60601-2-18:2009

Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

IEC 60601-1-8:2012

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

IEC 60825-1:2014

Safety of laser products - Part 1: Equipment classification and requirements

EMC

IEC 60601-2-1: 2014

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

性能指标

ISO 11146

 Lasers and laser-related equipment — Test methods for laser beam widths, divergence angles and beam propagation ratios 

IEC 62471：2026

Photobiological safety of lamps and lamp systems

ISO 60825-1：2017

Safety of laser products - Part 1: Equipment classification and requirements

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 10993-4:2017

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

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 10993-11:2017

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

ISO 10993-23:2021

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

灭菌过程管理和效果检测

ANSI/AAMI ST98:2022

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

ISO 22441:2022

Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 17665:2024

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 11137-2:2013

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1

ISO 14937:2009

Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

ISO 11731-1:2018

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products

ISO 11737-2:2019

Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

ISO 10993-7:2008

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

包装运输

ASTM D4169

Standard Practice for Performance Testing of Shipping Containers and Systems