Medical industry testing service capabilities

Release Date:
2023-08-13

Views:


Packaging simulation transportation:

ISTA 2 series (partial simulated transportation performance test): 2A, 2B

ISTA 3 series (comprehensive simulation transportation performance test): 3A, 3B, 3E

ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems

YY/T 0681.15-2019 Test Methods for Packaging of Sterile Medical Devices Part 15: Performance Testing of Transport Containers and Systems

GB/T 4857 Series of Basic Test Methods for Transport Packaging


医疗行业检测服务能力



Shelf life of packaging/accelerated aging of packaging:

YY/T 0681.1-2018 Test Methods for Packaging of Sterile Medical Devices Part 1: Guidelines for Accelerated Aging Testing

ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices


Environmental testing:

GB/T 14710-2009 Environmental Requirements and Test Methods for Medical Electrical Appliances


Reliability/Product Life:

GB/T 34986-2017 Accelerated Test Methods for Products

GB/T 5080.7-1986 Equipment Reliability Testing - Verification Test Plan for Failure Rate and Mean Time Between Failures under the Assumption of Constant Failure Rate


Medical batteries:

GB/T 28164-2011 Safety Requirements for Portable Sealed Batteries and Battery Sets Containing Alkaline or Other Non acidic Electrolytes

GB 8897.4-2008 Primary batteries - Part 4: Safety requirements for lithium batteries

GB 31241-2022 Safety technical specifications for lithium-ion batteries and battery packs used in portable electronic products

IEC/EN 62133-1:2017 Batteries and battery packs containing alkaline or other non acidic electrolytes - Safety requirements for portable sealed batteries and battery packs - Part 1: Nickel series

IEC 62133-2:2017/AMD1:2021, EN 62133-2:2017/A1:2021 Batteries and battery packs containing alkaline or other non acidic electrolytes - Portable sealed batteries and battery packs - Part 2: Lithium series

UL 1642: 2020 Lithium Battery Standard

UL 2054: 2021 Safety Standard for Household and Commercial Batteries

UL 2056:2020 Mobile Power Supply Safety Survey Summary

UN 38.3 and Cargo Transportation Condition Appraisal Report


医疗行业检测服务能力

医疗行业检测服务能力