產(chǎn)品詳情
產(chǎn)品質(zhì)檢
? 每批產(chǎn)品均參照中國藥典進行不溶性微粒檢測
? 所有的產(chǎn)品均進行2次外觀檢測,確保流出的每一個產(chǎn)品均無可視異物
? 每款產(chǎn)品的最小包裝均有批號標記,方便產(chǎn)品的質(zhì)量查詢
體系認證
? 符合 ISO 13485(醫(yī)療器械質(zhì)量管理體系)和ISO 9001認證
? 無菌水平達SAL10-6,無DNase/RNase,無內(nèi)毒素,無細胞毒性
生產(chǎn)環(huán)境
? 十萬級、局部百級潔凈環(huán)境下生產(chǎn)、包裝
? 包裝原材料為萬級生產(chǎn)環(huán)境
原材料驗證
? 所有的注塑件均采用醫(yī)用級原材料生產(chǎn)
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