GB/T 14233.2-2005 PDF EnglishUS$155.00 · In stock · Download in 9 seconds
GB/T 14233.2-2005: Test methods for infusion, transfusion, injection equipment for medical use -- Part 2: Biological test methods Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB/T 14233.2: Historical versions
Similar standardsGB/T 14233.2-2005: Test methods for infusion, transfusion, injection equipment for medical use -- Part 2: Biological test methods---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT14233.2-2005 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.20 C 31 Replacing GB/T 14233.2-1993 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use – Part 2.Biological Test Methods Issued on. NOVEMBER 17, 2005 Implemented on. MAY 1, 2006 Jointly Issued by. General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ); Standardization Administration (SAC) of the People's Republic of China. Table of ContentsForeword... 3 Introduction... 4 1 Scope... 5 2 Normative References... 5 3 Sterility Test... 6 4 Bacterial Endotoxin Test... 8 5 Pyrogen Test... 11 6 Acute Systemic Toxicity Test... 13 7 Hemolytic Test... 15 8 Cytotoxicity Test... 17 9 Sensitization Test (Maximum Dose Method)... 21 10 Intradermal Reaction Test... 23 11 Implantation Test... 24 Appendix A (Informative) Sub-acute (Sub-chronic) Systemic Toxicity Test ... 29 Appendix B (Informative) Interaction Test With Blood (Devices)... 35 Appendix C (Informative) Preparation of Common Cell Culturing Solution and Culture Solution... 481 ScopeThis Part of GB/T 14233 specifies the biological test methods of medical infusion, transfusion and injection equipment. This Part is applicable to medical infusion, transfusion and injection equipment.2 Normative ReferencesThe following normative documents contain provisions which, through reference of this Part of GB/T 14233, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrigendum) or revisions of these publications do not apply. However, all parties who enter into an agreement according to this standard are encouraged to study whether the latest editions of these documents are applicable. For undated references, the latest edition of the normative documents referred to applies. GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing (GB/T 16886.1-2001, IDT ISO 10993-1.1997) GB/T 16886.4 Biological Evaluation Of Medical Devices - Part 4.Selection of Tests for Interactions with Blood (GB/T 16886.4-2003, ISO 10993-4.2000, IDT) GB/T 16886.5 Biological Evaluation of Medical Devices - Part 5.Test for in Vitro Cytotoxicity (GB/T 16886.5-2003, ISO10993-5.1999, IDT) GB/T 16886.6 Biological Evaluation of Medical Devices - Part 6.Tests for Local Effects after Implantation (GB/T 16886.6-1997, IDT ISO 10993-6.1996)3 Sterility Test3.1 Purpose This test inoculates the medical equipment or its vat liquor into culture medium, so as to test if the test substance is subject to bacteria and fungus contamination. 3.2 Reagent Sodium chloride solution of which the mass concentration is 9 g/L, and other diluent and flushing fluid that meet the requirements of Chinese Pharmacopoeia. 3.3 Main Equipment Super-clean bench, optical microscope, constant temperature incubator, thermostatic water bath, pressure steam sterilizer, and electric drying oven 3.4 Preparation Before the Test 3.5 Culture Medium It is used to cultivate aerobic (anaerobic) bacteria and fungus, the sensitivity inspection of culture medium. Other requirements shall comply with the provisions of "Sterility Test Method" in Appendix of "Chinese Pharmacopoeia (Part II)".4 Bacterial Endotoxin Test4.1 Purpose This test is the "Gel Method" as specified in "Bacterial endotoxin test method" of Appendix in "Chinese Pharmacopoeia (Part II)". It utilizes the mechanism of agglutination produced by TAL (Tachypleus Amebocyte Lysate) and bacterial endotoxin, so as to judge if the maximum level of bacterial endotoxin in test substance meets the requirements. 4.2 Reagent National standard product of bacterial endotoxin, working standard product of bacterial endotoxin, TAL(Tachypleus Amebocyte Lysate), and examination water for bacterial endotoxin. 4.3 Main Equipment Super-clean bench, constant temperature incubator, thermostatic water bath, electric drying oven, and vortex mixers. 4.4 Preparation Before Test 4.4.1 Instrument Treatment The vessel for the test needs to be treated to remove the possibly existing exogenous endotoxin. Put the glass dish in electric drying oven at 180°C to dry-roast for at least 2h, or at 250°C to dry-roast for at least 30min. 4.4.2 TAL (Tachypleus Amebocyte Lysate) sensitivity verification test 4.4.3 Test substance interference test 4.5 Test Methods 4.5.1 Test substance quantity For the same batch, at least 3 units of test substance are required. 4.5.2 Leaching medium Examination water for bacterial endotoxin. 4.5.3 Test solution preparation According to the bacterial endotoxin limits specified by product standard to determine the leaching medium volume, it shall select the following suitable methods to prepare test solution. 4.5.4 Test procedure and result judgment They shall be conducted according to the requirements of "Gel Method" in "Inspection method of bacterial endotoxin" of Appendix of "Chinese Pharmacopoeia (Part II)". 4.5.5 Test Report The following information should be provided in the test report.5 Pyrogen Test5.1 Purpose In this test, inject the leach liquor of medical equipment into rabbit vein; observe the rise of body temperature of rabbit, so as to judge if the test substance has potential material thermogenic action. 5.2 Reagent It is the aseptic pyrogen-free sodium chloride injection with mass concentration of 9g/L. 5.3 Main Equipment Super-clean bench, electric drying oven, electric heating thermostatic water bath, pressure steam sterilizer, and pyrogen tester. 5.4 Preparation Before Test 5.4.1 Pyrogen removal from instrument All the glass dishes in contact with test solution are dry-roasted at 180°C in electric drying oven for at least 2h, or at 250°C for at least 30 min. Other appropriate methods may also be adopted to remove pyrogen. 5.4.2 Temperature measurement instrument Pyrogen thermodetector or clinical thermometer for rectal use with the precision of ±0.1°C shall be adopted to determine the body temperature of rabbit. 5.5 Test Method 5.5.1 Test solution preparation Appropriate leaching condition shall be selected according to the requirements of GB/T 16886.12. 5.5.2 Test procedure It shall be conducted according to the requirements of "pyrogen test" of Appendix in "Chinese Pharmacopoeia (Part II)" with the injection amount of rabbit as 10mL/kg. 5.5.3 Result judgment If the test substance meets the requirements of "pyrogen test" in Appendix of "Chinese Pharmacopoeia (Part II)" after preliminary examination or re-examination, they are judged as free from material thermogenic action. 5.6 Test Report Test report should provide the following information.6 Acute Systemic Toxicity Test6.1 Purpose In this test, inject the leach liquor of medical equipment into the vein and inner cavity of mice; observe whether the mice have toxic reaction and death within specified time, so as to judge whether the test substance has potential acute systemic toxicity action. 6.2 Reagent The sodium chloride injection with mass concentration of 9 g/L, and fresh refined vegetable oil. 6.3 Main Equipment and Tool Pressure steam sterilizer, animal balance, and hypodermic needle. 6.4 Preparation before test 6.4.1 Instrument sterilization All the equipment which are to contact with the test solution shall be placed in the pressure steam sterilizer at the temperature of 121°C for 30 min. 6,4.2 Preparation for the test animal 6.5 Test Method 6.5.1 Preparation of test solution Appropriate leaching conditions are selected according to the requirements of GB/T 16886.12; sodium chloride injection with the mass concentration 9 g/L and two types of leach liquor of vegetable oil are prepared for each test substance. Control solution of leaching medium is prepared under the same conditions. 6.5.2 Test solution injection 6.5.3 Observation of animal reaction after injection After completion of injection, observe the immediate reaction of mice; observe and record the general state, toxic performance and dead animal number of the treatment group and control group animals at 4h, 24h, 48h and 72h; weigh the animal body mass at 72h. Animal reaction observation judgment is specified according to Table 1. 6.5.4 Result judgment 6.5.4.1 Within observation period of 72h, if the reaction of animals in test team is not greater than the animals in control group, the test substance is judged as free from acute systemic toxic reaction. 6.5.4.2 If two or more animals in test group have medium toxic symptom or die, the test substance is judged as with acute systematic toxic reaction. 6.5.4.3 If the animals in test group have slight toxic symptom, or not more than one animal has medium toxic symptom, or die, or that although the animal is free from toxic symptom, but the mass of animal body in the group drops generally, then take another 10 mice as a group for retest. If the retest results meet the requirements of 6.5.4.1, the test substance is judged as free from acute systematic toxic reaction. 6.6 Test Report The following information should be provided in the test report.7 Hemolytic Test7.1 Purpose In this test, the medical equipment is directly in contact with blood. External hemolysis degree of test substance is judged through determination of hemoglobin amount released by red blood cell. This test is not applicable to evaluate the equipment-with- drug. 7.2 Reagent Potassium oxalate, sodium chloride injection with the mass concentration of 9 g/L, and fresh anticoagulant rabbit blood. 7.3 Main equipment Electric heating constant temperature water bath, spectrophotometer and centrifuger. 7.4 Preparation of Test Solution 7.5 Fresh Diluted Anticoagulant Rabbit Blood Preparation Blood is taken from the hearts of healthy rabbits according to the blood volume for test. If 10mL of blood is taken, add 0.5 ml of potassium oxalate solution with the mass concentration of 20 g/L; prepare it into fresh anticoagulant rabbit blood. Take 8 mL of fresh anticoagulant rabbit blood; add 10mL of sodium chloride injection with the mass concentration of 9 g/L for dilution. 7.6 Test Method For test substance group, each tube is added with 5g of test substance; or in the case of 7.4.2, add test substance with the leaching proportion specified in GB/T 16886.12; add 10mL of sodium chloride injection then. 7.7 Result Calculation Mean of three tubes is taken for absorbance of test substance group and control group. The absorbance of negative control tube shall not be greater than 0.3; and that of positive control tubes shall be 0.8± 0.3; otherwise retest shall be conducted. 7.8 Result Judgment Appropriate acceptance judgment index is determined according to the expected clinical usage and equipment material characteristics of medical equipment. 7.9 Test Report The following information should be provided in the test report.8 Cytotoxicity Test8.1 Purpose In this test, medical equipment leach liquor is in contact with cultured cell; the test substance's toxic effect on external cells is evaluated according to the observation of cellular morphology, proliferation and inhibition influence. 8.2 Reagent Sodium chloride, potassium chloride, calcium chloride, magnesium sulfate, disodium hydrogen phosphate, monopotassium phosphate, sodium hydroxide, glucose, phenol red, trypan blue, disodium EDTA (EDTA), trypsin, Eagle culture medium, RPMI 1640 culture medium, (fetal) calf serum, Penicillin G (sodium benzoate), streptomycin sulphate, ethanol, phenol, and dimethyl sulfoxide (DMSO). 8.3 Main Equipment and Instrument Super-clean bench, carbon dioxide (CO2) incubator, constant temperature water bath, refrigerator, inverted microscope, optical microscope, pressure steam sterilizer, suction flask, magnetic stirrer, and culture plate (ware). 8.5 Test Methods 8.5.1 Cell strain For cell strain in test, ATCC CCLI [NCTC clone 929 (L cell) or other suitable cells may be adopted. Vigorous cells with passage of 48 h~ 72 h shall be adopted for test. 8.5.2 Leaching medium The cell culture liquid with or without serum, the sodium chloride injection with the mass concentration of 9 g/L. 8.5.3 Control sample 8.6 Result Judgment Test substance cytotoxicity reaction degree is analyzed and judged under the condition that negative control and positive control produce the expected reaction. Notes 1.The test solution inspection concentration recommended in this test is 100 %,; it is applicable to medical infusion, transfusion and injection equipment. Other types of medical equipment may adjust test solution inspection concentration according to clinical application condition, e.g. 100%, 75%, 50% and 25% etc. 8.7 Test Report The following information should be provided in the test report.9 Sensitization Test (Maximum Dose Method)9.1 Purpose In this test, medical equipment leaching liquor is adopted to contact the cavy skin to evaluate the potentiality of delayed type hypersensitivity of test substance initiated under test conditions. 9.2 Reagent Sodium chloride injection, fresh refined vegetable oil, rochlorobenzene (dinitrochlorobenzene, DNCB), sodium lauryl sulfate, and Freund complete adjuvant with mass concentration of 9 g/L. 9.3 Main Equipment and Instrument Pressure steam sterilizer, electric razor, hypodermic syringe, and glass mortar. 9.4 Preparation Before Test 9.5 Test Methods 9.5.3 Preparation of test solution According to the requirements of GB/T 16886.10, select appropriate leaching conditions, sodium chloride injection with the mass concentration 9 g/L, and/or vegetable oil leaching liquor. 9.5.4 Test procedure and result judgment They shall be operated according to "Maximum Dose Sensitization Test" specified in GB/T 16886.10. 9.6 Test Report The following information should be provided in the test report. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |
