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Testing Center of Radio-ogica-Medical Research I nstitute,SooChOWUniversityTest Report                
Report Number:SDFY一2007—2582      
Medical device clinical test report
 
Sample Name:Borne nasal spray
Testing Item:Biocompatibility Test
Sample Supplier:Beijing borne tech Co,．Ltd
Supplementary Explanation
1.If demur at the analysis report please raise it within 1 5 days by receiving the report,otherwise will not be accepted．
2.Testing report is void without analysis center seal．
3.Valid report must be signed by ones who analyzed,reviewed and issued it．
4.Any erasure renders a report null and void．
5.Testing result of supply sample is only responsible for the provided sample．
6.Copyright of analysis report reserved by the analysis center,if need copy,please get permission from the center first,and Can only make a whole copy．
Table of Contents
Page number
Cytotoxicity Test…………………………………………………………………………………………….4
Delayed Contact Sensitization Study In the Guinea Pig………………………….7
Skin Irritation Test………………………………………………………………………………………..10
 
Cytotoxicity Test
Summary
The test article,Borne nasal spray,were evaluated for cytotoxicity test in accordance with the ISO10993-5:1999:Tests for in vitro cytotoxicity ASTM F813-07 and USP(87):Biological Reactivity Test,In Vitro—Elution test．The testing sample solution is mixed with growing-well L-929 cell,and then incubated for 48h and 72h at 37~C in 5％C02．Intracytoplasmic granulethe and cell lysis was observed．
The result shows that the Reactivity Grade of negative control is 0 grade;the Reactivity Grade of positive control is 4 grade and the Reactivity Grade of sample article is 1 grade．This means that the test is valid and the sample article has no toxicity to L-929 cell．
Date completed:Nov 4,2007
Testedby:Ming Ping  Checkedby:Lin Fenju
 
Introduction
The test article,Borne nasal spray,were evaluated for cytotoxicity in accordance with 1 0993—5,1 999:Tests for in vitro cytotoxicity ASTM F8 1 3．07 and USP(87):Biological Reactivity Test,In Vitro—Elution test．The purpose of this study was to determine the potential cytotoxicity of the testing article to L-929 cell．    .
Test system and test system Management
L-929 mammalian fibroblast cell will be grown in RPMI 1 640 supplemented with 1 0％serum,1 00 U／ml penicillin and 1 00 μ g／ml streptomycin．Cells will be seeded into the 96-well cell culture plates,and incubated at 37℃ in a humidified incubator with 5％C02 to obtain confluent monolayers of cells prior to use．Aseptic procedures will be used in the handling of cell culture．
Facility:SDFY is an ISO／IEC 1 7025:2005 accredited  lab．The number of Lab Accreditation
Certificate is:No CNAS L2954．
Personnel:Associates involved were appropriately qualified and trained．   more.....