GB/T 14233.2-1993 Translated English of Chinese Standard. (GBT 14233.2-1993, GB/T14233.2-1993, GBT14233.2-1993): Infusion, transfusion, injection equipment for medical use - Part 2: Biological test methodshttps://www.chinesestandard.net, 31/03/2020 - 33 من الصفحات This Standard specifies biological performance test methods for finished products and materials of infusion, transfusion, injection equipment for syringes. This Standard is applicable to biological performance tests of infusion, transfusion, injection and supporting equipment that are made of medical polymer materials. Other medical polymer products can also refer to this Standard for use. |
المحتوى
3 | |
Rabbit pyrogen test | 6 |
Bacterial endotoxin test | 10 |
Acute systemic toxicity test | 13 |
Hemolysis test | 15 |
Chapter Two Material test | 17 |
Intradermal stimulation test | 20 |
Skin sensitization test | 22 |
Shortterm muscle implantation test | 25 |
Annex A Preparation of mediums | 29 |
Annex B Preparations of cell culture solution digestive solution balanced salt solution Supplementary | 31 |
عبارات ومصطلحات مألوفة
100mL of stock 1mL of extraction Add 1mL aerobic and anaerobic agar anaerobic medium anal thermometer Appliance sterilization appliances in contact bacterial endotoxin bacterial growth blank control solution body temperature cell culture solution Definition This test dissolve edema electric drying oven erythema ethanol extract solution Extraction medium 0.9 fibroblasts Freund's complete adjuvant glucose hemocytometer hemolysis implantation incubating at 30~35°C item or negative Main equipment medium per 3cm2 mice mold medium negative control Number of test observe Penicillin pentobarbital Peptone Place at 60°C positive control solution positive control tube Potassium dihydrogen phosphate Preparation before test Preparation of test pressure steam sterilizer pyrogen pyrogen test pyrogen-free water rabbit hair re-test Reagents sodium chloride injection solid appliances solution of test staphylococcus aureus Sterility test sterilize at 115°C sterilizer to sterilize Stock solution sub-packaging surface area tachypleus amebocyte lysate temperature measurement test item group Test methods test solution test tubes tissue trypan blue trypsin