婴儿辐射保暖台注册检测

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 9706.103-2020

医用电气设备 第1-3部分：基本安全和基本性能的通用要求 并列标准：诊断X射线设备的辐射防护

YY/T 9706.110-2021

医用电气设备 第1-10部分：基本安全和基本性能的通用要求 并列标准：生理闭环控制器开发要求

YY 9706.221-2023

医用电气设备 第2-21部分：婴儿辐射保暖台的基本安全和基本性能专用要求

YY 9706.250-2023

医用电气设备 第2-50部分：婴儿光治疗设备的基本安全和基本性能专用要求

YY 9706.249-2023

医用电气设备 第2-49部分：多参数患者监护仪的基本安全和基本性能专用要求

GB 9706.227-2021

医用电气设备 第2-27部分：心电监护设备的基本安全和基本性能专用要求

YY 9706.230-2023

医用电气设备 第2-30部分：自动无创血压计的基本安全和基本性能专用要求

YY 9706.261-2023

医用电气设备 第2-61部分:脉搏血氧设备的基本安全和基本性能专用要求

GB 9706.255-2022

医用电气设备 第2-55部分：呼吸气体监护仪的基本安全和基本性能专用要求

YY 9706.235-2021

医用电气设备 第2-35部分：医用毯、垫或床垫式加热设备的基本安全和基本性能专用要求

YY 9706.256-2023

医用电气设备 第2-56部分：用于体温测量的临床体温计的基本安全和基本性能专用要求

YY 0600.5-2011

医用呼吸机 基本安全和主要性能专用要求 第5部分：气动急救复苏器

YY/T 0636.1-2021

医用吸引设备 第1部分：电动吸引设备

YY/T 0636.3-2021

医用吸引设备 第3部分：以真空或正压源为动力的吸引设备

YY/T 0461-2003

麻醉机和呼吸机用呼吸管路

YY/T 1040.1-2015

麻醉和呼吸设备 圆锥接头 第1部分：锥头与锥套

YY/T 1040.2-2008

麻醉和呼吸设备 圆锥接头 第2部分：螺纹承重接头

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

YY/T 1778.1

医疗应用中呼吸气体通路生物相容性评价 第1部分：风险管理过程中的评价与试验

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

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

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 60601-1-3:2008

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC 60601-1-10：2007

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

IEC 60601-2-21：2020

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

IEC 60601-2-27: 2011

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

IEC 60601-2-50: 2020

Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

IEC 60601-2-35：2020

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

ISO 10651-5:2006

Lung ventilators for medical useParticular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators

ISO 10079-1:2022

Medical suction equipment - Part 1: Electrically powered suction equipment

ISO 10079-3:2022

Part 3: Suction equipment powered from a vacuum or positive pressure gas source

ISO 5367:2023

Anaesthetic and respiratory equipment - Breathing sets and connectors

ISO 5356-1:2015

Anaesthetic and respiratory equipment — Conical connectors Part 1: Cones and sockets

ISO 5356-2:2012

Anaesthetic and respiratory equipment — Conical connectors Part 2: Screw-threaded weight-bearing connectors

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

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

加速老化

ASTM F1980-21

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