GB/T 14233.3-2024 English PDFUS$369.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 14233.3-2024: Test methods for infusion, transfusion, injection equipments for medical use - Part 3: Microbiological test methods Status: Valid
Basic dataStandard ID: GB/T 14233.3-2024 (GB/T14233.3-2024)Description (Translated English): Test methods for infusion, transfusion, injection equipments for medical use - Part 3: Microbiological test methods Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C31 Classification of International Standard: 11.040.20 Word Count Estimation: 18,121 Date of Issue: 2024-10-26 Date of Implementation: 2026-11-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 14233.3-2024: Test methods for infusion, transfusion, injection equipments for medical use - Part 3: Microbiological 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/GBT14233.3-2024 ICS 11.040.20 CCSC31 National Standard of the People's Republic of China Inspection methods for medical infusion, blood transfusion and injection equipment Part 3.Microbiological test methods Released on October 26, 2024 Implementation on November 1, 2026 State Administration for Market Regulation The National Standardization Administration issued Table of ContentsPreface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Sterility test 2 4.1 Materials and Instruments 2 4.2 Test Environment 3 4.3 Method design and validation 3 4.4 Test sample testing 5 Bacterial endotoxin test 4 5.1 Materials and Instruments 4 5.2 Test Environment 5 5.3 Method design and validation 5 5.4 Test sample 6 5.5 Test report 6 6 Bioburden Determination 7 6.1 Materials and Instruments 7 6.2 Test Environment 7 6.3 Method Design and Validation 7 6.4 Product Testing 8 7 Sterility test 9 7.1 Materials and Instruments 9 7.2 Test environment 10 7.3 Method design and validation 10 7.4 Product Testing 10 Reference 12 Preface This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document is Part 3 of GB/T 14233 "Test methods for medical infusion, blood transfusion and injection equipment". GB/T 14233 has been published. The following sections. --- Part 1.Chemical analysis methods; --- Part 2.Biological test methods; --- Part 3.Microbiological test methods. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106). This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Shandong Weigao Group Medical Polymer Products Co., Ltd. Company, Johnson & Johnson (Suzhou) Medical Devices Co., Ltd., Suzhou Baxter Medical Products Co., Ltd., Medtronic (Shanghai) Management Co., Ltd., Jiangxi San Xin Medical Technology Co., Ltd., Lepu (Beijing) Medical Devices Co., Ltd., Henan Tuoren Medical Devices Group Co., Ltd., Shandong Zhongbaokang Medical Equipment Co., Ltd. The main drafters of this document are. Luan Yuanyuan, Wang Wenqing, Long Jing, Qin Jie, Li Lingmei, Gong Yaoren, Liu Bingrong, Yang Tingru, Cui Jingqiang, Gong Xiangyang, Zhang Mengmeng, Sun Lingxiao, Li Cui, Ma Heng, and Fang Aihua.introductionGB/T 14233 "Test methods for medical infusion, blood transfusion and injection equipment" is planned to consist of three parts. --- Part 1.Chemical analysis methods. The purpose is to provide chemical analysis methods for medical infusion, blood transfusion and injection equipment. --- Part 2.Biological test methods. The purpose is to provide biological test methods for medical infusion, blood transfusion and injection equipment. --- Part 3.Microbiological test methods. The purpose is to provide microbiological test methods for medical infusion, blood transfusion and injection equipment. Microbiological testing performed on infusion, transfusion, and injection equipment products generally includes. --- Sterility test for sterile finished products; --- Bacterial endotoxin testing of sterile finished products; --- Determination of the total number of microorganisms on products given in GB/T 19973.1; --- GB/T 19973.2 gives the sterility tests used for the definition, validation and maintenance of the sterilization process. This document covers the above. The "sterility test" given in this document is applicable to products that undergo routine sterilization or aseptic processing and is based on reference to the pharmacopoeias of various countries. It is formulated based on the specific characteristics of infusion, blood transfusion and injection equipment. At the same time, the sterility test methods listed in this document have been verified to replace "Sterility test" in GB/T 14233.2-2005.Sterility test is often used for supervision and random inspection. If the sterility test does not meet the requirements, it indicates that the product The presence of microbial contamination under these test conditions confirms that the sample represents a population of viable microorganisms. Sterility testing is not a substitute for The development, validation and routine control of the sterilization process are used for product release. To demonstrate a sterility assurance level of 10-6, millions of products need to be tested. Sterility test is a destructive test, so such a high number of tests is obviously impossible to achieve, so sterility test cannot be used to confirm The sample represents a population that meets the sterility assurance level of 10-6.If the sterility test meets the requirements, it only means that the sample has not If microbial contamination is found, it is “not detected”. The "Bacterial Endotoxin Test" given in this document is applicable to products that undergo routine sterilization doses or aseptic processing, and is based on reference to the pharmacopoeias, This document is based on ISO 11737-3 and other standards, and is developed based on the specific characteristics of infusion, blood transfusion and injection equipment. The test method has been verified to replace the "Bacterial Endotoxin Test" in GB/T 14233.2-2005.Bacterial endotoxin test is often used in daily quality control. The methods specified in this document include gel method and photometric method. When necessary for the inspection of special medical devices, new bacterial endotoxin inspection methods such as the recombinant factor C method and the microgel method may be used when applicable. The "bioburden determination" given in this document is applicable to products to be sterilized and is the same as GB/T 19973.1 for medical infusion, blood transfusion and syringes. Bioburden includes the number, characteristics and properties of microorganisms. The bioburden determination given in this document refers specifically to sterilization. Test method for the number of microorganisms on pre-products. The "sterility test" given in this document is applicable to products that have been subjected to a sterilization dose lower than that of conventional sterilization. It is the same as GB/T 19973.2 in medical infusion and transfusion. This test is used to verify the number of viable microorganisms in all products after being subjected to certain sterilization conditions. To facilitate the distinction, this document uses the terms “sterility inspection” and “sterility test”. Represents two test types respectively. If applicable, microbiological tests in the inspection of other types of medical device products shall be conducted with reference to this document after verification. Inspection methods for medical infusion, blood transfusion and injection equipment Part 3.Microbiological test methods 1 Scope This document describes the sterility testing of medical infusion, blood transfusion, and injection equipment, bacterial endotoxin testing, bioburden determination, and sterility testing. method. This document applies to medical infusion, blood transfusion and injection equipment. 2 Normative references The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 19973.1 Microbiological methods for sterilization of health care products Part 1.Determination of the total number of microorganisms on the product 3 Terms and Definitions The following terms and definitions apply to this document. 3.1 Sterility test A technical operation performed on a product that has been aseptically processed or sterilized to check its sterility. 3.2 A sterility inspection/sterility test method in which the product is directly immersed in liquid culture medium for cultivation. 3.3 The liquid product or non-liquid product is washed with a flushing solution and the eluate is filtered through a membrane and the filter membrane is cultured for sterility testing. Sterility test method. 3.4 medium filling method A sterility inspection/sterility test method in which liquid culture medium is filled into the internal cavity or passage of the product for cultivation. 3.5 medium elution method Use liquid culture medium to elute the microorganisms that may be present on the product and collect the eluted culture medium for culture sterility test/sterility test Test method. 3.6 The use of Limulus amebocyte lysate (LAL) to detect or quantify bacterial endotoxins produced by Gram-negative bacteria to determine the limit of bacterial endotoxins in products. Whether it complies with regulations. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 14233.3-2024_English be delivered?Answer: Upon your order, we will start to translate GB/T 14233.3-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. 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