Standard Number: YY/T 1579-2018(YY/T1579-2018)
Chinese:体外诊断医疗器械 体外诊断试剂稳定性评价
English:In vitro diagnostic medical devices-Evaluation of stability of in vitro diagnostic reagents
Effective Date:2019-03-01
ICS:11.100
Standard Applicability:This standard applies to the stability evaluation of in vitro diagnostic medical devices (including reagents, calibrators, quality control substances, diluents, buffers and kits). This standard also applies to sample collection devices that contain substances for preserving samples or initiating reactions to further process samples. This standard specifies general requirements for stability evaluation and specific requirements for real-time stability and accelerated stability when generating data from the following processes: (1) Establishing the shelf life of in vitro diagnostic reagents, including the determination of transportation conditions to ensure product performance; (2) Establishing the stability in use of an in vitro diagnostic reagent after the initial package has been opened for the first time, e.g., in-vessel stability, reconstitution stability, and vial-opening stability; ( (3) Monitoring the stability of in vitro diagnostic reagents that have been placed on the market; and (4) Verification of stability after reagent improvement. After the reagent is improved, the stability may be affected and the stability needs to be verified. This standard does not apply to instruments, devices, equipment, systems, specimen containers, test samples.
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