医用激光光纤注册检测

项目说明

标准编号

标准名称

性能要求

YY/T 0758-2021

医用激光光纤通用要求

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

YY 9706.111-2021

医用电气设备 第1-11部分：基本安全和基本性能的通用要求并列标准：在家庭护理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

GB 9706.222-2022

医用电气设备 第2-22部分：外科、整形、治疗和诊断用激光设备的基本安全和基本性能专用要求

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

GB/T 18268.26-2010

测量、控制和实验室用的电设备 电磁兼容性要求 第26部分:特殊要求 体外诊断(IVD)医疗设备

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 16886.3-2019

医疗器械生物学评价 第3部分：遗传毒性、致癌性和生殖毒性试验

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 16886.7-2015

医疗器械生物学评价 第7部分：环氧乙烷灭菌残留量

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

化学表征＆毒理学

GB/T 16886.17-2025

医疗器械生物学评价第 17部分:医疗器械成分的毒理学风险评估

GB/T 16886.18-2022

医疗器械生物学评价 第18 部分:风险管理过程中医疗器械材料的化学表征

清洗消毒灭菌验证

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

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 热湿 第1部分:医疗器械灭菌过程的开封、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

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

IEC60601-1-

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

IEC 60601-2-22:2019

Medical electrical equipment—Part2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

EN IEC 60601-2-22:2020

Medical electrical equipment—Part2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

EMC

IEC 61326-2-6:2025

Electrical equipment for measurement, control and laboratory use -EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical electrical equipment

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

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 10993-3:2014

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

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 10993-6:2016

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

ISO 10993-7:2008

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

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

化学表征＆毒理学

ISO 10993-17:2023

Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

ISO 10993-18:2020

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

清洗消毒灭菌验证

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

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

ISO 25424-2018 / Amd 1-2022

Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment

AAMI ST79:2017 10

Comprehensive guide to steam sterilization and sterility assurance in health care facilities

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

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

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