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