Product Testing Service
Kanglife has reached strategic cooperation with many testing laboratories at home and abroad to help customers obtain faster, better and more cost-effective testing services. At the same time, we provide scientific and reasonable testing solutions based on customers' plans for product launch.
Laboratory Qualifications
Laboratory Qualifications
Safety Test
Standard List of Medical Device (Non-Exhaustive)
- 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
Standard List of In Vitro Diagnostic Medical Devices (Non-Exhaustive)
- 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
EMC Test
Standard List of Medical Device (Non-Exhaustive)
- 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
Standard List of In Vitro Diagnostic Medical Devices (Non-Exhaustive)
- 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
Other Test
- RoHS
- Reach
- WEEE
- Radio/Wireless
- Biocompatibility
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