GB/T 35511-2017
ActiveBiological requirements and test methods for closures of butyl rubber
丁基橡胶瓶塞生物性能要求与试验方法
Application Summary AI generated
This standard specifies the biological safety requirements and corresponding test methods for butyl rubber closures used in pharmaceutical packaging, such as rubber stoppers for infusion bottles, lyophilized powder vials, and prefilled syringes. It is applied by medical device and pharmaceutical manufacturers to ensure that these closures are non-toxic, non-pyrogenic, and free from hemolytic or cytotoxic effects before they contact injectable drugs or biological products. The standard is also used by quality control and regulatory bodies in the healthcare industry to verify compliance during product certification and batch release testing.
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