Extraction Ratio definition
Extraction Ratio. 6 cm2 : 1 ml 3 cm2 : 1 ml 1.25 cm2 : 1 ml 0.2g : 1 ml 0.1 g : 1 ml Fill to Capacity Leave it blank if don’t know. . Extraction Condition : (50±2)℃ for (72±2) h (70±2)℃ for (24±2) h (121±2)℃ for (1±0.1) h (37±1)℃ for (72±2) h 37℃ for 24 h (Cytotoxicity only) : 1. Recommended extraction condition: Cytotoxicity test: 37℃ for 24h, and other test: 50℃ for 72h or more. : 37°C for 24h 50℃ for 72h 2. In some cases, temperatures above 37 °C result in chemicals that may not occur in clinical use and may result in adverse biological responses not representative of the medical device in its final finished form. 37°C * Ignore this part if the samples are not going to be extracted. On the premise that the sample must not be cut and the whole sample is obtained, if the surface area or weight exceeds a certain amount, an additional extraction fee shall be charged. Items Tests Test Methods Extractant(s) Standards Note Application No. MTT Method MTT MEM with Serum Cytotoxicity Elution Test Direct Contact Agar Diffusion MEM without Serum GB/T 16886.5-2017 ISO 10993-5:2009 Filter Diffusion Not Applicable Irritation Skin Irritation - Extraction - Skin Irritation - Direct Contact - Intracutaneous Reactivity Penile Irritation Rectal Irritation Vaginal Irritation Ocular Irritation Oral Mucosa Irritation Polar Non-polar Not applicable GB/T 16886.10-2017 ISO 10993-23:2021 Items Tests Test Methods Extractant(s) Standards Note Application No. Sensitization GPMT ( Prefered) Buehle Test, BT Polar Non-polar Not Applicable GB/T 16886.10-2017 ISO 10993-10:2021 System Toxicity (Acute) Injection (iv or ip) ( ) Gavage Polar Non-polar Not Applicable GB/T 16886.11-2021 ISO 10993-11:2017 Pyrogenicity Material - Mediated Pyrogen Rabbit Method 2020 USP <151> Bacterial Endotoxin Gel-clot Limit Test Sub-acute Injection (iv or ip) ( ) Implant in Subcutaneous Gavage Period Polar Non-polar Not Applicable GB/T 16886.11-2021 ISO 10993-11:2017 Sub-chronic Genotoxicity Bone Marrow Micronucleus (MN) Bacterial Gene Mutation (▇▇▇▇) Polar Non-polar GB/T 16886.3-2019 ISO 10993-3:2014 Mouse Lymphoma Assay (MLA) Treated Time 4H 4H, 24H Polar 1640 Non-polar 95% DMSO Chromosome Aberration Test Polar Non-polar Implantation in Muscle in Subcutaneous Tissue in Bone in Brain Period: 3 periods need to be provided for degradable materials. GB/T 16886.6-2022 ISO 10993-6:2016 Haemo-compatibility Hemolysis - directly WHO ( ) PTT PT Platelet Count Leukocyte Count In Vivo Thromboresistance Study GB/T 16886.4-2022 ISO 10993-4...