No.
Revision:
Effective:
Page:
EZKZ01
V2.0
2020-03-28
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SHANGHAI EARNTZ NONWOVEN.,LTD
Technical File of Earntz Protective Face Mask
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CHAPTER 6 PRODUCT VERIFICATION AND VALIDATION .....................................
6.1 Biocompatibility test report ................................................................................. 24
6.2 Product performance test report ......................................................................... 24
6.3 Usability evaluation report .................................................................................. 25
6.4 Packaging aging and Transportation evaluation reports .................................... 25
CHAPTER 7 CLINICAL EVALUATION .......................................................................
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CHAPTER 8 POST-MARKET SURVEILLANCE .........................................................
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