射频消融设备注册检测

项目说明

标准编号

标准名称

安规、EMC和专用标准

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 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

YY 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 9706.202-2021

医用电气设备 第2-2部分：高频手术设备及高频附件的基本安全和基本性能专用要求

GB 4824-2019

工业、科学和医疗设备 射频骚扰特性 限值和测量方法

YY 0650-2022

射频消融治疗设备通用技术要求

YY/T 0776-2023

肝脏射频消融治疗设备

YY 0778-2018

射频消融导管

YY/T 1057-2016

医用脚踏开关通用技术条件

GB/T 25000.51-2016

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 0860-2024

心脏射频消融治疗设备

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 16886.11-2021

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

清洗消毒灭菌验证

WS/T 367-2012

医疗机构消毒技术规范

WS 310系列

医院感染控制标准 / 清洗消毒及灭菌技术操作规范

YY/T 0802.1-2024

医疗器械的处理 医疗器械制造商提供的信息 第1部分：中高度危险性医疗器械

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1部分：低度危险性医疗器械

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 19973.2-2018

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 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/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

环境、软件和包装运输

YY/T 0664-2020

医疗器械软件 软件生存周期过程

GB/T 14710-2009

医用电器环境要求及试验方法

GB/T 4857 系列

包装 运输包装件基本试验

项目说明

标准编号

标准名称

安规、EMC和专业标准

IEC 60601-1-1:2014

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

IEC 60601-1-2:2014

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

IEC 60601-1-6:2010

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

IEC 60601-1-8:2006

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-2-2：2017

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

CISPR 11:2015

Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement

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 10993-11:2017

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

清洗消毒灭菌验证

AAMI TIR30:2011

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

ANSI/AAMI ST98:2022

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

AAMI TIR12:2020

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

ISO 17665-1-2006

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

ISO 11737-1:2018

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

加速老化

ASTM F1980-21

Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices