温控消融导管注册检测

项目说明

标准编号

标准名称

安规

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

医用电器设备 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

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

专用标准

GB 9706.202-2021

医用电气设备 第2-2部分：高频手术设备及附件的基本安全和基本性能专用要求

YY 0778-2018

射频消融导管

生物相容性试验

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

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 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 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

灭菌效果检测（生产过程）

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

包装运输

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

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

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 10993-4:2017

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 10993-12:2021

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

ISO 10993-23:2021

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

灭菌过程管理

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 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

灭菌效果检测（生产过程）

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 D 4169

Standard Practice for Performance Testing of Shipping Containers and Systems