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Page 1:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 2:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 3:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 4:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 5:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 6:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 7:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 8:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 9:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 10:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 11:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 12:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 13:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai
Page 14:  · Skin Sensitization Test of Plain Medical Surgical Mask Sponsor: Address: According to ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract Shenzhonghai

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ISO 10993—Biological Evaluation of Medical Devices 10993.pdf · ISO 10993—Biological Evaluation of Medical Devices ... materials, then step back for a global “device-look”

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Technology INTRODUCTION Overview- EN ISO 10993-11: 2015 “Biological evaluation of medical devices. Part 11. Test for systemic toxicity.” - ISO 10993 -5: 2015 (EN ISO 109935: 2009,

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Cosmetics - LAUS Group• In vitro Eye Irritation - OECD 437 BCOP Test - EpiOcular Eye Irritation Test - HET Cam Test • In vitro Skin Sensitization - Direct Peptide Reactivity Assay