激光生发帽注册检测

项目说明

标准编号

标准名称

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

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

GB/T 14710-2009

医用电气环境要求及试验方法

YY/T 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

YY 0709-2009

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

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

GB/T 18268.1-2025

测量、控制和实验室用的电设备电磁兼容性要求 第1部分：通用要求

医疗器械软件

YY/T 0664-2020

医疗器械软件 软件生存周期过程

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 16886.12-2023

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

清洗消毒验证

WS 310系列

医院消毒供应中心系列规范

WS/T 367-2012

医疗机构消毒技术规范

YY/T 1495-2016

清洗消毒效果的微生物验证方法

YY/T 1623-2018

可重复使用医疗器械灭菌过程有效性的试验方法

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2部分：低度危险性医疗器械

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

GB/T 19633.1-2015

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

YY/T 0681系列标准

无菌医疗器械包装试验方法

GB/T 19633.1-2015

最终灭菌医疗器械包装-材料、无菌屏障系统和包装系统的要求

GB/T 19633.2-2015

最终灭菌医疗器械包装-成型、密封和装配过程的确认的要求

包装运输

GB/T 4857.4-2008

包装 运输包装件基本试验 第4 部分：采用压力试验机进行的抗压和堆码试验方法

项目说明

标准编号

标准名称

电气安全

IEC60601-1:2005 +A1:2012 + A2:2020

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

IEC60601-1-6:2010+ A1:2013 + A2: 2020

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

IEC 60601-1- 

8:2006+A2:2020

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-

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 61326-1:2020

Electrical equipment for measurement, control and laboratory use -EMC requirements - Part 1: General requirements

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

医疗器械软件

IEC 62304:2006+A1:2015

Medical device software - Software life cycle processes

EN 62304:2006+A1:2015

Medical device software - Software life cycle processes

BS EN 62304:2006+A1:2015

Medical device software - Software life cycle processes

生物学评价

ISO 10993-1:2018

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 10993-12:2021

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

清洗消毒验证

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 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

医疗器械包装验证

ASTM F1980-2016

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

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 1: Requirements for materials, sterile barrier systems and packaging systems

DIN 58953-6:2025-03

Sterilisation - Sterilgutversorgung - Teil 6: Prüfung der Keimdichtigkeit von Verpackungsmaterialien für zu sterilisierende Medizinprodukte

包装运输

ASTM D 4169

Standard Practice for Performance Testing of Shipping Containers and Systems