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Position: Chinese Standard in English/GB/T 14233.2-2005
GB/T 14233.2-2005   Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods (English Version)
Standard No.: GB/T 14233.2-2005 Status:valid remind me the status change

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Implemented on:2006-5-1 Delivery: via email in 1 business day
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Standard No.: GB/T 14233.2-2005
English Name: Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
Chinese Name: 医用输液、输血、注射器具检验方法 第2部分:生物学实验方法
Chinese Classification: C31    General and microsurgical devices
Professional Classification: GB    National Standard
ICS Classification: 11.040.20 11.040.20    Transfusion, infusion and injection equipment 11.040.20
Issued by: AQSIQ
Issued on: 2005-11-17
Implemented on: 2006-5-1
Status: valid
Superseding:GB/T 14233.2-1993 Infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
Language: English
File Format: PDF
Word Count: 16000 words
Price(USD): 150.0
Delivery: via email in 1 business day
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
Referred in GB/T 14233.2-2005:
*GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
*GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
*GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity
*GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation
*GB/T 16886.10-2017 Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitization
*GBT16886.1l-
*GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
*Pharmacopoeiaof-
GB/T 14233.2-2005 is referred in:
* YY/T 0821-2010 Dispensing syringe for single use
* YY 0321.3-2009 Single-use filter for anaesthesia
* YY/T 0908-2013 Single-use filter for syringe
* YY 0321.3-2009 Single-use filter for anaesthesia
* YY 0321.3-2009 Single-use filter for anaesthesia
* YY 0469-2011 Surgical mask
* YY 0502-2005 Knee joint prostheses
* GB 8369-2005 Transfusion sets for single use
* GB 15811-2016 Sterile hypodermic needles for single use
*YY 0477-2004 Rigid gas permedable contact lenses for orthokeratology
*YY 0477-2004/XG1-2016 Rigid gas permeable contact lenses for orthokeratology
*YY 0778-2010 Radio frequency ablation catheter
*GB 19083-2010 Technical requirements for protective face mask for medical use
*YY 1282-2016 Intravenous catheter for single use
*YY 1272-2016 Dialysis fluid filter
*GB 18671-2009 Intravenous needles for single use
*YY 0502-2016 Joint replacement implants―Knee joint prostheses
*YY 0118-2016 Joint replacement implants - Hip joint prostheses
*GB 15810-2019 Sterile syringes for single use
*GB 19082-2009 Technical requirements for single-use protective clothing for medical use
*YY 0118-2005 Hip joint prostheses
*GB 8368-2005 Infusion sets for single use, gravity feed
*YY/T 1794-2021 General technical requirements for dental collagen membrane
*GB 19335-2003 Blood flow products for single use—General specification
*YY/T 1287.3-2016 Intracranial external drainage system- Part 3:Intracranial external drainage catheter
*YY 0341.2-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 2:Particular requirements for spinal implants
*GB 8369.2-2020 Transfusion sets for single use—Part 2: With pressure infusion apparatus use
*YY 0613-2007 Blood components separation sets for single use centrifuge bag type
*GB/T 19335-2022 Blood flow products for single use-General specification
Code of China
Standard
GB/T 14233.2-2005  Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods (English Version)
Standard No.GB/T 14233.2-2005
Statusvalid
LanguageEnglish
File FormatPDF
Word Count16000 words
Price(USD)150.0
Implemented on2006-5-1
Deliveryvia email in 1 business day
Detail of GB/T 14233.2-2005
Standard No.
GB/T 14233.2-2005
English Name
Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
Chinese Name
医用输液、输血、注射器具检验方法 第2部分:生物学实验方法
Chinese Classification
C31
Professional Classification
GB
ICS Classification
Issued by
AQSIQ
Issued on
2005-11-17
Implemented on
2006-5-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
GB/T 14233.2-1993 Infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
Language
English
File Format
PDF
Word Count
16000 words
Price(USD)
150.0
Keywords
GB/T 14233.2-2005, GB 14233.2-2005, GBT 14233.2-2005, GB/T14233.2-2005, GB/T 14233.2, GB/T14233.2, GB14233.2-2005, GB 14233.2, GB14233.2, GBT14233.2-2005, GBT 14233.2, GBT14233.2
Introduction of GB/T 14233.2-2005
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 of GB/T 14233.2-2005
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
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Keywords:
GB/T 14233.2-2005, GB 14233.2-2005, GBT 14233.2-2005, GB/T14233.2-2005, GB/T 14233.2, GB/T14233.2, GB14233.2-2005, GB 14233.2, GB14233.2, GBT14233.2-2005, GBT 14233.2, GBT14233.2