YY/T 0513.3-2020 English PDFUS$249.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0513.3-2020: Allogeneic grafts - Part 3: Demineralized bone grafts Status: Valid YY/T 0513.3: Historical versions
Basic dataStandard ID: YY/T 0513.3-2020 (YY/T0513.3-2020)Description (Translated English): Allogeneic grafts - Part 3: Demineralized bone grafts Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C45 Classification of International Standard: 11.040.40 Word Count Estimation: 13,11 Date of Issue: 2020 Date of Implementation: 2021-01-01 Issuing agency(ies): State Drug Administration Summary: This standard specifies the definitions, specifications, requirements, test methods, labeling, instructions, packaging, transportation and storage requirements for demineralized bone. This standard applies to demineralized bone products prepared from human bone tissue. YY/T 0513.3-2020: Allogeneic grafts - Part 3: Demineralized bone grafts---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Allogeneic grafts--Part 3.Demineralized bone grafts People's Republic of China Pharmaceutical Industry Standards YY/T 0513.3-2020 replaces YY/T 0513.3-2009 Released on 2020-02-21 Implementation of.201-01-01 Issued by the National Medical Products Administration 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Specifications 2 5 Raw material requirements and control of external factors 2 6 Requirements 2 7 Test method 3 8 Labels, instructions 4 9 Packaging, transportation and storage 5 Appendix A (Normative Appendix) Donor requirements for demineralized bone products 6 Appendix B (informative appendix) Method for measuring residual water content of freeze-dried demineralized bone 7 Appendix C (informative appendix) Demineralization degree detection method 8 Reference 9 ForewordYY/T 0513 "Allogeneic Restorative Materials" is divided into the following parts. ---Part 1.The basic requirements of the organization library; ---Part 2.Deep-freezing bone and freeze-dried bone; ---Part 3.Demineralized bone. This part is part 3 of YY/T 0513. This section was drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces YY/T 0513.3-2009 "Allogeneic Bone Repair Materials Part 3.Demineralized Bone", and YY/T 0513.3- Compared with.2009, the main technical changes except for editorial changes are as follows. ---The standard name was revised to "Allogeneic Restorative Materials Part 3.Demineralized Bone"; --- Deleted "This product is suitable for the surgical treatment of human bone repair" in the "Scope" (see Chapter 1, Chapter 1 of the.2009 edition); --- Added "Normative Reference Document GB/T 16886.11 Medical Device Biological Evaluation Part 11.Systemic Toxicity Test" (See Chapter 2, Chapter 2 of the.2009 Edition); --- Deleted the term "3.2, 3.3, 3.6, 3.7, 3.8"; ---Modified "Specifications", no longer stipulating the minimum specific size of the product, emphasizing that the quantity and the size of the customized product should be marked (see Chapter 4, Chapter 4 of the.2009 edition); --- Modify "raw material requirements" to "raw material requirements and control of exogenous factors", in which 5.1 is changed to meet the requirements of Appendix A; 5.2 pairs The requirements of the production process have been added to the regulatory requirements that should be met; 5.3 has been moved to the product biological evaluation section 6.7.5 (see section 5. Chapter, Chapter 6, Chapter 5 of the.2009 Edition); ---Modified the content required by the "Specifications" (see Chapter 6, Chapter 6 of the.2009 Edition); ---Modified the "water content" requirements, consistent with the American Association of Tissue Banks (AATB) standards (see Chapter 6,.2009 Edition 6); --- Move the sterility requirement before the biological evaluation (see Chapter 6, P6 of the.2009 edition); ---Added "pyrogen test" and "pyrogen test method" in the biological evaluation (see Chapter 6 and Chapter 7); ---Modified the "implantation test", clarified the implantation cycle requirements and precautions for local implantation and long-term in situ implantation test (see section 6 Chapter, Chapter 7 of the.2009 Edition); ---Modified the "Ectopic Osteogenesis Test" (see Chapter 6, Chapter 7 of the.2009 Edition); ---Added "intradermal reaction test" (see Chapter 6) and "intradermal reaction test method" (see Chapter 7); --- Added "Systemic Acute Toxicity Test" (see Chapter 6) and "Systemic Acute Toxicity Test Method" (see Chapter 7); --- Added "Subchronic Toxicity Test" (see Chapter 6) and "Subchronic Toxicity Test Method" (see Chapter 7); --- Deleted the "inspection rules" (Chapter 8 of the.2009 edition); ---Added "immunological test" and its methods (see Chapter 6 and Chapter 7); --- Modify "marks, instructions" to "labels, instructions" and modify the content to meet the requirements of regulations, and also list "packaging, transportation, storage" Chapter 9 of the terms (see Chapter 8, Chapter 9, Chapter 9 of the.2009 edition); ---The temperature and storage time limit requirements in "Packaging, Transportation, and Storage" have been added, which are consistent with the AATB standard. (See Chapter 9,.2009 Chapter 9 of the edition); ---Modified the "packaging" content (see Chapter 5, Chapter 9 of the.2009 edition); --- Deleted "Appendix A (informative appendix) Reference specifications for demineralized bone products" (Appendix A of the.2009 edition); --- Deleted "Appendix C (informative appendix) Osteoinductive activity test of demineralized bone products" (Appendix C of the.2009 edition); --- Deleted "Appendix D (informative appendix) Demineralized bone pH test method", and its related content is merged in the standard text "acid-base" Degree" (see Chapter 7, Appendix D of the.2009 Edition); ---Revised part of "Appendix B" (see Appendix B, Appendix E of the.2009 edition); ---Revised part of "Appendix C" (see Appendix C, Appendix F of the.2009 edition). Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This part was proposed by the State Drug Administration. This part is under the jurisdiction of China Institute of Food and Drug Control. Drafting organizations of this section. Shanxi Provincial Medical Tissue Bank, China Food and Drug Control Research Institute, Chinese People's Liberation Army General Hospital. The main drafters of this section. Li Baoxing, Zhao Yaping, Shao Yaming, Wang Xianmei, Xu Liming, Shao Anliang, Guo Quanyi, Feng Xiaoming, Xi Tingfei. Allogeneic restorative materials. Part 3.Demineralized bone1 ScopeThis part of YY/T 0513 specifies the terms and definitions, specifications, requirements, test methods, labels, instructions, packaging, and transportation of demineralized bone And storage requirements. This section applies to demineralized bone products prepared from human bone tissue.2 Normative referencesThe following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management GB/T 16886.3 Biological Evaluation of Medical Devices Part 3.Genetic Toxicity, Carcinogenicity and Reproductive Toxicity Test GB/T 16886.5 Biological Evaluation of Medical Devices Part 5.In Vitro Cytotoxicity Test GB/T 16886.6 Biological evaluation of medical devices Part 6.Local reaction test after implantation GB/T 16886.10 Biological Evaluation of Medical Devices Part 10.Stimulus and Delayed Hypersensitivity Test GB/T 16886.11 Biological Evaluation of Medical Devices Part 11.Systemic Toxicity Test GB/T 16886.20 Biological Evaluation of Medical Devices Part 20.Principles and Methods of Immunotoxicology Tests for Medical Devices GB/T 19633.1 Packaging for terminally sterilized medical devices Part 1.Requirements for materials, sterile barrier systems and packaging systems YY 0033 Production and Management Standards for Sterile Medical Devices YY 0236 Composite film for pharmaceutical packaging (general rules) YY/T 1680-2020 Allogeneic repair material demineralized bone material in vivo osteogenic induction performance evaluation "The Pharmacopoeia of the People's Republic of China".2015 Edition (Part IV)3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 3.2 The process of using hydrochloric acid or other substances to remove minerals from tissues. 3.3 Note. This section specifically refers to allogeneic bone repair materials.4 SpecificationsIt should be marked by weight and volume, and special shapes should be marked with geometric dimensions.5 Raw material requirements and control of external factors5.1 The donor of allogeneic bone should meet the requirements of Appendix A. 5.2 Allogeneic bones should be contaminated by viruses and other exogenous factors.6 Requirements6.1 Specifications It should not exceed ±10% of the identification value or meet the processing specifications proposed by the user. 6.2 Appearance It is white or slightly yellow, and the bone morphology and structure are clear. No bone marrow and blood components should be attached. 6.3 pH The pH of the product extract is between 5.5 and 7.5. 6.4 Residual water volume of freeze-dried demineralized bone The residual water content of freeze-dried demineralized bone should be less than 6% (weightlessness method). 6.5 Degree of demineralization The calcium content of demineralized bone should not exceed 8%. 6.6 Sterility It should be sterile. 6.7 Biological evaluation 6.7.1 General Biological evaluation should be carried out in accordance with GB/T 168886.1. 6.7.2 Cytotoxicity test Should not be greater than level 1. 6.7.3 Sensitization test There should be no sensitization. 6.7.4 Pyrogen test There should be no pyrogen reaction. 6.7.5 Genotoxicity test There should be no genotoxicity. 6.7.6 Implantation test Divided into subcutaneous short-term implantation, select appropriate experimental animals according to GB/T 168886.6, the test period is 12 weeks, and the tissues surrounding the implant material There should be no obvious accumulation of neutrophils and tissue necrosis; for long-term in situ implantation, select appropriate experimental animals according to GB/T 168886.6. The period is not less than 26 weeks. The implant material should form an osseointegration with the adjacent host bone without abnormal pathological reactions. Note 1.The marketed product can be used as a control sample and implanted in the same way. There is no significant difference in the pathological response between the test material and the control material. Note 2.In order to exclude adverse reactions caused by differences in species between human bone tissue and experimental animals, it can be combined with a comprehensive evaluation of the material's performance in human clinical applications. 6.7.7 Ectopic osteogenic induction test The ectopic osteogenic induction test of demineralized bone should be positive. 6.7.8 Immunological test There should be no obvious immune rejection. 6.7.9 Intradermal reaction test There should be no intradermal irritation. 6.7.10 Systemic acute toxicity test There should be no systemic acute toxicity. 6.7.11 Subchronic toxicity test There should be no subchronic toxicity.7 Test method7.1 Specifications Use a balance or measuring tool that meets the accuracy requirements for testing, and the results should meet the requirements of 6.1. 7.2 Appearance Visual observation, the results should meet the requirements of 6.2. 7.3 pH According to the.2015 edition of the Pharmacopoeia of the People's Republic of China (Part IV) 0631pH determination method. Take 2g of fully demineralized cancellous bone strips or 2g～10g fully demineralized cortical bone strips are immersed in 20 times volume of freshly boiled and cooled purified water (pH 5.5～7.0), ultrasonically vibrated for 10 minutes and then allowed to stand for 10 minutes, and the pH of the supernatant is measured with an acidity meter., Repeat 3 times and take the average value. The result should meet the requirements of 6.3. 7.4 Residual water volume of freeze-dried demineralized bone Refer to Appendix B for testing, and the results should meet the requirements of 6.4. 7.5 Degree of demineralization Refer to Appendix C for testing, and the results should meet the requirements of 6.5. 7.6 Sterility Perform sterility inspection according to the.2015 edition (Part 4) of the "Pharmacopoeia of the People's Republic of China", 1101 sterility inspection method. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0513.3-2020_English be delivered?Answer: Upon your order, we will start to translate YY/T 0513.3-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0513.3-2020_English with my colleagues?Answer: Yes. 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