产品检测服务

与国内外多家检测实验室达成战略合作，可以帮客户争取更快、更优、更具性价比的检测服务。同时，结合客户对产品上市的规划，提供科学、合理的检测方案。

医疗器械标准清单（非详尽）

IEC/EN 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC/EN 62304 – Medical device software – Software life cycle processes
IEC/EN 62366 – Medical devices – Part 1: Application of usability engineering to medical devices; or
IEC/EN 60601-1-6 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
IEC/EN 60601-1-8 – 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/EN 60601-1-11 – 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/EN 60601-1-12 – 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 intended for use in the emergency medical services environment
IEC/EN 60825-1 – Safety of laser products – Part 1: Equipment classification and requirements

体外诊断医疗器械标准清单（非详尽）

IEC/EN 61010-1 – Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
IEC/EN 61010-2-101 – Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC/EN 61010-2-081 – Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
IEC/EN 61010-2-010 – Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-010: Particular requirements for laboratory equipment for the heating of materials
IEC/EN 61010-2-051 – Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-051: Particular requirements for laboratory equipment for mixing and stirring
IEC/EN 60825-1 – Safety of laser products – Part 1: Equipment classification and requirements

医疗器械标准清单（非详尽）

IEC/EN 60601-1-2 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

体外诊断医疗器械标准清单（非详尽）

IEC/EN 61326-1 – Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements（FDA：IEC/EN 60601-1-2）
IEC/EN 61326-2-6 – Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
IEC/EN 61326-2-2 – Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-2: Particular requirements – Test configurations, operational conditions and performance criteria for portable testing, measuring and monitoring equipment used in low-voltage distribution systems