Medical device Package test

Medical device Package test

The package of medical device plays an important role in maintaining sterile environment and protecting property for sterile medical device. Leon Biotech follow international standards ISO 11607 and EN868, ASTM regulations to provide well-established and validated testing services for medical device package and shipping package, we are based on the following specifications:

Testing target

Test item

Method

Aging study

constant temperature and moisture test storageASTM F1980

Package material

Burst test ASTM F1140
Creep test
Dye penetrationASTM F1929
Microbial barrier test ASTM F1608
Microbial barrier test DIM 58953-6

Intrinic matter

Sterility test ISO 11737-2

Package material

Seal peel test ASTM F88

服務內容

 

中國

  1. 國產 /進口醫療器械 中國註冊服務
  2. 中國 醫療器械動物試驗設計及臨床 豁免評估
  3. NMPA 中國醫療器械產品注册及可用性評估
    產品技術要求撰寫
    產品註冊檢驗追蹤
    產品註冊申報資料編寫
    註冊補充資料技術指導
    專家審評會組織協調
  4. NMPA 中國醫療器械臨床試驗
    臨床試驗方案及總結報告撰寫
    臨床試驗項目管理
    臨床試驗監察
    臨床試驗數據管理
    臨床試驗統計分析
    稽查及培訓
    臨床試驗數據採集分析系統
    臨床評價報告(CERCER)撰寫