1 Scope
This 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 equipments.
2 Normative References
The 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 amending errors in the text) to, or revisions of, any of these publications do not apply. However, all parties coming to 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)
GB/T 16886.10 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed-type Hypersensitivity (GB/T 16886.10-2005, ISO 10993-10: 2002, IDT)
GB/T 16886.1l Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity (GB/T 16886.11-1997, Idt ISO 10993-11: 11993)
GB/T 16886.12 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials(GB/T 16886.12-2005, ISO 10993-12: 2002, IDT)
Pharmacopoeia of People's Republic of China Part II
3 Sterility Test
3.1 Purpose
This test inoculates medical equipment or its vat liquor into culture medium to test if the test substance is subject to bacteria and fungus contamination.
3.2 Reagent
Mass concentration is 9 g/L sterile sodium chloride solution and other diluent and flushing fluid to meet the requirements of Chinese Pharmacopoeia.
3.3 Main Equipment
Superclean bench, optical microscope, constant temperature incubator, thermostatic waterbath, pressure steam sterilizer and electric drying oven
3.4 Preparation Before the Test
3.4.1 Instrument sterilization
All the equipment to contact with the test solution shall be sterilized with sterilization - put in pressure steam sterilizer at 121 ℃ for 30min or in electric drying oven at 160 ℃ for 2h.
3.4.2 Disinfection chamber requirements
3.4.2.1 Partial disinfection chamber operating table or superclean bench shall meet the requirements of unidirectional airflow section at cleanliness class l00. After completion of disinfection treatment on the disinfection chamber, the colony number in the air shall be inspected, with the following methods: taking the petri dish with the diameter of about 90 mm; as for the aseptic operation, about 20mL of melted nutrient agar medium is injected, cultivated at 30℃~35℃ for 48h and proved sterile, three petri dishes are taken with the upper cover opened at the mean position of disinfection chamber operating table or superclean bench, superclean bench in contact for 30min, covered with cover and placed at 30℃~35℃ and cultivated for 48h and be taken out for inspection. The colony number growing on the three petri dishes shall not exceed 1.
3.4.2.2 The colony number in the air shall be inspected in the process of sterility test with the method as shown above. Opening petri dish cover at the beginning of the test and covering at the end of the test, the test conducted according to the above method and shall meet the above-mentioned requirements.
3.5 Culture Medium
The preparation for culture medium to cultivate aerobic (anaerobic) bacteria and fungus, the sensitivity inspection of culture medium and other requirements shall meet the requirements of "Sterility Test Method" in Appendix of "Chinese Pharmacopoeia (Part II)".
3.6 Test Substance Bacterial Inhibition Proof Test
As for the unknown or doubtable test substance, method proof test shall be conducted according to the requirements of "Sterility Test Method" in appendix of "Chinese Pharmacopoeia Part II" before the sterility test to confirm that the test substance is free from bacteriostatic activity or the bacteriostatic activity is negligible under the test conditions.
3.7 Test Method
3.7.1 Test substance quantity
As for the same batch No., there are 3~11 units of test substance.
Note: Other types of medical equipment may b adopted by reference according to specific conditions.
3.7.2 Leaching medium
Sterile sodium chloride solution with mass concentration of 9 g/L and other diluent and flushing fluid to meet the requirements of "Chinese Pharmacopoeia".
3.7.3 Preparation of test solution
Test substance or its representative parts are adopted preferentially to be directly put into the culture medium for cultivation. If the test substance is unsuitable for being directly put in, the test solution may be prepared according to the following method and leaching medium shall be sufficiently to elute the leaching surface of test substance. The test solution preparation shall be conducted according to the aseptic method and applied two hours after preparation.
The following suitable methods shall be selected according to the specific characteristics of test substance:
a) Tube category instruments: 1mL leaching medium to flow the tube inside chamber for every 10 cm2 of the tube inside surface area with the flow of 10mL/ min.
b) Vessel instrument: as for the vessel with liquid, the liquid in the vessel may be taken out directly as test solution; as for the empty vessel, add 1mL leaching medium for every 10cm2 of the inner surface area of the vessel, shake several times.
c) Solid instrument: as for the solid instrument, add 1mL leaching medium every 10 cm2 of the surface area and shake several times.
3.7.4 Inoculation, cultivation and observation
The suitable Inoculation mode specified in "sterility test method" of Appendix in "Chinese Pharmacopoeia (Part II)" is selected according to the specific property of test substance and conducted with aseptic method.
The cultivation and observation of test substance shall be conducted according to the requirements of "Sterility Test Method" in appendix of "Chinese Pharmacopoeia (Part II)".
3.7.5 Result judgment
It is conducted according to the requirements of "Sterility Test Method" in Appendix of "Chinese Pharmacopoeia (Part II)".
3.7.6 Test report
The following information should be provided in the test report.
a) Test substance name
b) Production batch No. and (or) sterilization batch No.;
c) Test solution preparation method;
d) Inoculation mode;
e) Daily observation;
f) Result judgment.
Contents
Foreword I
Introduction II
1 Scope
2 Normative References
3 Sterility Test
4 Test on Zymoid in Bacteria
5 Pyrogen Test
6 Acute Systemic Toxicity Test
7 Hemolytic Test
8 Cytotoxicity Test
9 Sensitization Test (Maximum Dose Method)
10 Intradermal Reaction Test
11 Implantation Test
Appendix A (Informative) Subacute (Subchronic) Systemic Toxicity Test
A.1 Purpose
A.2 Reagents
A.3 Main Equipment and Tool
A.4 Preparation Before Test
A.5 Test Methods
A.6 Test Report
Appendix B (Informative) Interaction Test With Blood (Apparatus and Instruments)
B.1 General Provisions
B.2 Phlebothrombosis Test in Vivo
B.3 Whole Blood Clotting Time Test
B.4 Test for Partial Thromboplastin Time (PTT)
B.5 Extracorporeal Spontaneity Platelet Agglutination Test
B.6 Platelet Adhesion Test
B.7 Complement Activation Test
Appendix C (Informative) Preparation of Common Cell Culturing Solution and Culture Solution
C.1 Balanced Salt Solution (BSS)
C.2 Digestion Solution
C.3 Methyl Thiazolyl Tetrazolium (MTT) Staining Solution
C.4 RPMl 1640 Cell Culture Solution
