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GB/T 14233.2-2005 English PDF (GBT14233.2-2005)

GB/T 14233.2-2005 English PDF (GBT14233.2-2005)

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GB/T 14233.2-2005: Test methods for infusion, transfusion, injection equipment for medical use -- Part 2: Biological test methods

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 equipment.
GB/T 14233.2-2005
GB
NATIONAL STANDARD OF THE
PEOPLE 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 Contents
Foreword ... 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 ... 48
Foreword
GB 14233 "Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use" is divided into two parts.
- Part 1. Chemical Analysis Method;
- Part 2. Biological Test Methods.
This Part is Part 2 of GB/T 14233. This Part replaces GB/T 14233.2-1993 "Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 2. Biological Test Methods". For the 3 tests - sterile, pyrogen and bacterial endotoxin, this revision directly quotes the applicable chapters and sections of "Chinese Pharmacopoeia (Part II)", so as to keep in line with the updated and revised edition of Chinese Pharmacopoeia; cytotoxicity test methods were modified by reference to GB/T 16886 "Biological Evaluation of Medical Devices"; GB/T 16886 "Biological Evaluation of Medical Devices" was directly quoted by reference for sensitization, intradermal reaction and implantation test; test methods for sub-acute (sub-chronic) systemic toxicity and blood (equipment) interaction were added; product acceptance judgment indexes were deleted. Appendix A, Appendix B and Appendix C in this Part are informative.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee on Medical Syringes of Standardization Administration of China.
Drafting organizations of this Part. Jinan Center for Medical Equipment Quality Supervision and Testing of State Food and Drug Administration, and Tianjin Medical Biomaterial Monitoring Research Center.
Chief drafting staffs of this Part. You Shaohua, Zhu Xuetao, Liu Xin, Huang Jingchun, Wang Xin, Zhu Junmei, Wang Kelei, and Hao Shubin.
This Part was first-time issued in March, 1993.
Introduction
The biological test methods provided in this Part are based on the basic principles of GB/T 16886.1 "Biological Evaluation of Medical Devices. Part 1. Evaluation and Testing", and are established especially in accordance with the biological evaluation demand of medical infusion, transfusion and injection equipment. This revision is made on the basis of the corresponding test methodology principle and test procedures in GB/T 16886 "Biological Evaluation of Medical Devices" and "Chinese Pharmacopoeia (Part II)", and according to the characteristics of medical infusion, transfusion and injection equipment. Therefore, this Part shares methodology identity property with GB/T 16886 and the methods of "Chinese Pharmacopoeia"; it is applicable to the method standard of biological performance test of medical infusion, transfusion and injection equipment.
For the sterile, pyrogen and bacterial endotoxin tests, this revision directly quotes the applicable chapters and sections of "Chinese Pharmacopoeia", without the year number of pharmacopoeia noted, so as to be in line with the updated and revised edition of "Chinese Pharmacopoeia". For the test items without detailed test procedure given in GB/T 16886, they are refined, e.g. cytotoxicity, acute systemic toxicity, sub-acute (sub-chronic) systemic toxicity and tests in interaction with blood (equipment). For the stimulation, sensitization and implantation tests with test procedures given in detail in GB/T 16886, this revision directly adopts the corresponding sections of GB/T 16886.
This Part acts as the test method standard; this revision deletes the product acceptance judgment indexes in the main body, but provides the current general judgment indexes for reference in article note. The relevant product standards, when quoting this Part, shall specify the suitable acceptance judgment indexes according to the product application characteristics.
Test Methods for Infusion, Transfusion, Injection
Equipment for Medical Use ?€?
Part 2. Biological Test Methods
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 equipment. 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 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)
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 16886.11 Biological Evaluation of Medical Devices - Part 11. Tests for Systemic Toxicity (GB/T 16886.11-1997, IDT ISO 10993-11.1993)
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 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
3.4.1 Instrument sterilization
All the equipment that contact with the test solution shall be sterilized by reliable method - Put in pressure steam sterilizer at 121??C for 30min or in electric drying oven at 160??C for 2h.
3.4.2 Disinfection chamber requirements
3.4.2.1 Partial disinfection chamber operating table or super-clean bench shall meet the requirements of unidirectional airflow area at cleanliness class 100. After completion of disinfection treatment on the disinfection chamber, the colony number in the air shall be inspected, with the following methods. Take a petri dish with the diameter of about 90 mm; for the aseptic operation, inject about 20mL of melted nutrient agar medium; cultivate at 30??C~35??C for 48h. After it is confirmed as sterile, take 3 petri dishes; open the upper cover at the mean position of disinfection chamber operating table or super-clean bench; after exposing for 30min, cover it and place at 30??C~35??C to cultivate for 48h; take out for inspection. The colony number growing on the 3 petri dishes shall not exceed 1.
3.4.2.2...

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