颅内压传感器注册检测

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 9706.112-2021

医用电气设备　第1-12部分：基本安全和基本性能的通用要求　并列标准：预期在紧急医疗服务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 9706.234-2021

医用电气设备　第2-34部分：有创血压监护设备的基本安全和基本性能专用要求

性能要求

YY 0781-2010

血压传感器

YY/T 0754-2009

有创血压监护设备用血压传输管路安全和性能专用要求

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 16886.6-2022

医疗器械生物学评价 第6部分：植入后局部反应试验

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 16886.12-2023

医疗器械生物学评价 第12部分：样品制备与参照材料

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 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 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

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

无菌医疗器械包装验证

YY/T 0681.1-2018

无菌医疗器械包装试验方法 第1部分：加速老化试验指南

YY/T 0681系列

无菌医疗器械包装试验方法

最终灭菌医疗器械包装验证

GB/T 19633.1-2024

最终灭菌医疗器械包装 第1部分：材料、无菌屏障系统和包装系统的要求

GB/T 19633.2-2024

最终灭菌医疗器械包装 第2部分：成型、密封和装配过程的确认的要求

包装运输

GB/T 4857系列

包装 运输包装件基本试验

电气安全通用标准

IEC60601-1:2005+AMD1:2012+AMD2:2020 CSV

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

IEC 60601-1-6 2010+AMD1：2013+AMD2：2020 CSV

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

EC 60601-1-12:2014/Amd 1:2020

Medical Electrical Equipment — Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment — Amendment 1

EMC

IEC 60601-1-2：2014+AMD1：2020 CSV

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

电气安全专用标准

IEC 60601-2-34：2011

Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

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 10993-6:2026

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

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 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

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

加速老化

ASTM F1980-21

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

最终灭菌医疗器械包装验证

ISO 11607-1:2019

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 11607-2:2019

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

包装运输

ASTM D4169-23e1

Standard Practice for Performance Testing of Shipping Containers and Systems