Shandong Weigao Group Medical Polymer Co., Ltd Inspection Report Report No.:_SY2014-41 Description Tiel Type | / he 140226 | Quantity | 200000PCS Sterilization Sample Sample Date Feb.22.2014 Selection Date Feb.22.2014 Quantity 37PCS Executive B Mfg. date i Standard TSO8536-4:2007 ig. 02.2014 Exp. date 02.2019 Inspection Tt i i Inspection Items Standard Stipulations aa Biological Performance Sterilzation | Sterile Pass Pyrogen Pyrogenfee Pass Chemical Performance Indicator gays need any kind of stndard soluton CO.OImolD aan shouldbe ess than 1m con EO remain ‘<0.Sme'pes 0 UV absorbance ‘The test luquid shall not be more than 0.1 0.04 Reducing matter Consume KMnO4 volumeS=2.0ml 0.1m Particulate pollution | Pollution index: N=90 2.5 Physical Performance Particulte pollution | Particulate polktion index: N=Na-Nb<90 25 3 S0Kpaair pressure in 15s, no gas aking Pass raking =20Kpano gas in Pass The connection of the parts not include the protection cap should Tensile strength | be able to siand ISN static tension in 138 as Bote stopper, | Canpicrec:the cork and-not cause debris Pass puncture devive Intake pieces of cork puncture outfit or needle should have P: ass ‘Air suction rotection cap eatin Can be with the bottle puncture oullt_ or separate fom Pass ‘The flow should be no less than 20% 9%~12% Should be transparent enough and can distinguish hydration air a interfice, the length is less than 1500mm. oe The needle is clean | should be clean and no debris NA Necdb fie | no sharp area and bur injection moldng deftet NA Color of the needle NA NA file ThE baich of the producis by inspection accord with standard factory Inspection conclusion requirements, Conclusion: pass | Remarks Without needle Inspector: Hai Chee 3p EAWEGORG ‘{2SeS0BRRATHARGARAS YOUTTER Avr ia? SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., ITD. Biological Properties COA No. ¥2016061821 Entrusting Company _| Infusion Set Branch Company Manufacturing Infusion Set Branch | Test Environment | Temperature: 20° ¢ Company Company Humidity: 60% Product Name Infusion Set for Single | Sample Condition | In good condition Use Batch No. 20160601, Test Basis YZ8/National 0583-2014 Sterilization No. 2016060210303 | Test Classification | Type Test Specification OSS#withneedle | Test Quantity Ssets ‘Sample No. y2016061821 ‘Test Date 2016/06/21-2016/06/24 Testing Standard: ISO 10993-11: 2006(€)5 Acute Systemic Toxicity Test Test Item: ‘Technical Requirement: Should not have any acute systemic toxicity Equipment and Reagent: 0.9% sodium chloride solution, freshly refined cottonseed oil, pressure steam sterilizer, animal balance, 2ml syringe, and 41/2# syringe needle. 2. Test Method 2.1 All the appliance related to the test should be putted in to the drying cabinet at 115° C for 30 minutes to eliminate the pyrogen. 2.2 Test Animal Preparation Testing rats should be in qualified health condition. They all should be raised In the same condition(The temperature in laboratory and feeding room should be 19°28" C). All the rats should have the same origin and the same breed. Female rats should not be pregnant and their weight should be 17~23g. The rats that have taken this test should not be used repeatedly. Separate the rats into test group and control group randomly, and each team should contain 5 rats. During the retest, take 18~19g rats and 10 in each group. 2.3 Test Solution Preparation Take 5 samples and cut them into pieces. Put them Into 4g:20ml sterile sodium chloride solution, and place it under 121" C for 1 hour to make the polarity test solution, Under the same condition, make the polarity solution without samples as the control solution. Use the same method to make the non-polarity test solution and non-polarity control solution. The method is as same as above and the medium is cotton seed cil 2.4 Test solution Injection Inject the 0.9% sodium chloride solution and medium control solution into the caudal vein with the speed no more than O.1mi/s constantly. And the dosage should be SOmi/kg. After injection, observe the rats’ immediate reaction and if there are blood or test solution overflow ‘occurring, eliminate this rat and take other rat to operate. Inject the cotton seed oil leach liquor ‘and medium control solution into enterocoelia, and the dosage should be SOmI/ke. 2.5 Observation on animal reaction after reaction After the injection, the feeding method should be as same as before the test. Observe the= est YOUR HEALTH WE CARE ‘Addi No. 312, Shichang Road, Weihai, Shandong, China P.C.:264209 Tel: 0086-631-5620485 Fax: 0086-631-5622563 immediate reaction of rats and record the normal condition, toxicity expression and the death count of test group and control group in 4h, 24h, 48h, and 72h, 2.6 Result Evaluation 2.6.1 Within the 72h observation period, the animal reaction of test group is no larger than the control group, then the test item does not have acute systemic toxicity reaction. 2.6.2 If there are 2 or more than 2 animals appearing medium toxic symptom or death, then the test item has acute systemic toxicity reaction. 2.6.3 If there are 2 or more than 2 animals appearing slight toxic symptom, or no more than 1 animal appearing medium toxic symptom or death, then take another 10 of 18~19g rats as one ‘group for retest. Within the 72h observation period, the animal reaction of test group is no larger than the control group, then the test item does not have acute systemic toxicity reaction. Toxicity Reactions Degree | Symptom None _| No toxicity symptom Slight | Slight symptom without movement reduction, dyspnea, or ventral stimulation symptom, Medium | Ventral stimulation, dyspnea, movement reduction, ptosis, diarrhea, and the weight decreased to 15~17g. Significant | Collapse, cyanosis, tremor or severe venter stimulation symptom, diarrhea, ptosis or dyspnea occurs after injection(the mass reducesrapidlytolessthan15e) Death | Death occurs after injection Test Results There is no acute systemic tonicity.) Item Conclusion: Qualified. Note: Review: Wen Liu Checker: Gang Wang Date: 2016/06/24