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YY/T 0513.3-2020

Chinese Standard: 'YY/T 0513.3-2020'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0513.3-2020English259 Add to Cart Days<=3 Allogeneic grafts--Part 3: Demineralized bone grafts Valid YY/T 0513.3-2020
YY/T 0513.3-2020Chinese17 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YYT0513.3-2020 (YYT0513.3-2020)
Description (Translated English) Allogeneic grafts--Part 3: Demineralized bone grafts
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 13,130
Date of Issue 2020-02-21
Date of Implementation 2021-01-01
Older Standard (superseded by this standard) YY/T 0513.3-2009
Drafting Organization Shanxi Provincial Medical Organization Library, China Food and Drug Administration, Chinese People's Liberation Army General Hospital
Administrative Organization China Institute of Food and Drug test
Regulation (derived from) Announcement No. 20 of 2020 by the State Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 0513.3-2020
Allogeneic grafts--Part 3. Demineralized bone grafts
ICS 11.040.40
C45
People's Republic of China Pharmaceutical Industry Standard
Replace YY/T 0513.3-2009
Allogeneic repair materials. Part 3. Demineralized bone
Released on 2020-02-21
2021-01-01 implementation
Issued by the State Drug Administration
Contents
Foreword Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Specification 2
5 Raw material requirements and control of exogenous factors 2
6 Requirement 2
7 Test method 3
8 Labels, instructions 4
9 Packaging, Transportation, Storage 5
Appendix A (Normative Appendix) Donor Requirements for Demineralized Bone Products 6
Appendix B (informative appendix) Method for measuring the residual water content of freeze-dried demineralized bone 7
Appendix C (informative appendix) Demineralization degree detection method 8
Reference 9
Foreword
YY/T 0513 "Allogeneic Restorative Materials" is divided into the following parts.
--- Part 1. Basic requirements of organization library;
--- Part 2. Deep low temperature frozen 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 to.2009, the main technical changes except for editorial changes are as follows.
--- The standard name was changed to "Allogeneic Repair Materials Part 3. Demineralized Bone";
--- Deleted "the product is suitable for surgical treatment of human bone repair" in "Scope" (see Chapter 1, Chapter 1 of the.2009 edition);
--- Added "Normative Reference Document GB/T 16886.11 Biological Evaluation of Medical Devices Part 11. Systemic Toxicity Test"
(See Chapter 2, Chapter 2 of the.2009 edition);
--- Removed the terms "3.2,3.3,3.6,3.7,3.8";
--- Modified the "Specifications", no longer stipulate the specific minimum size of the product, emphasizing that the amount of loading and the size of customized products should be marked
Chapter 4 of the.2009 edition);
--- Modify "Raw Material Requirements" to "Raw Material Requirements and Control of Exogenous Factors", where 5.1 is changed to meet the requirements of Appendix A;
The requirements of the production process have been added to the regulatory requirements that should be met; move 5.3 to the product biological evaluation section 6.7.5 (see section 5
Chapter, Chapter 6, Chapter 5 of the.2009 edition);
--- Revised the content of "Specifications" (see Chapter 6, Chapter 6 of the.2009 edition);
--- Amended the "water content" requirement to be consistent with the American Association of Tissue Banks (AATB) standard (see Chapter 6,.2009 edition 6);
--- Move the sterility requirements before the biological evaluation (see Chapter 6, P6 of.2009 edition);
--- Added "pyrogenic test" and "pyrogenic test method" to biological evaluation (see Chapter 6 and Chapter 7);
--- Modified the "implantation test" to clarify 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 Induction 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 test method" (see Chapter 7);
--- Deleted "Inspection Rules" (Chapter 8 of the.2009 edition);
--- Added "immunological test" and its methods (see Chapter 6, Chapter 7);
--- Modify "Marks, Instructions" to "Label, Instructions" and modify the content to meet the requirements of the regulations, and also list "Packaging, Transportation, Storage"
Chapter 9 of the terms (see Chapter 8, Chapter 9, Chapter 9 of the.2009 edition);
--- Added requirements for temperature and storage time limit in "Packaging, Transportation, Storage", which is consistent with AATB standards. (See Chapter 9,.2009
Chapter 9 of the edition);
--- Revised the contents of "Packaging" (see Chapter 5, Chapter 9 of the.2009 edition);
--- Deleted "Appendix A (Informative Appendix) Reference Specifications of Demineralized Bone Products" (Appendix A of the.2009 edition);
--- Removed "Appendix C (Informative Appendix) Demineralized Bone Product Bone Induction Activity Test" (2009 version of Appendix C);
--- Deleted "Appendix D (informative appendix) Demineralized bone acidity and alkalinity test method", and its related content is incorporated in the standard body "Acid
Degree "(see Chapter 7, Appendix D of the.2009 edition);
--- Modified part of "Appendix B" (see Appendix B, Appendix E of the.2009 edition);
--- Modified part of "Appendix C" (see Appendix C, Appendix F of the.2009 edition).
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of China Food and Drug Administration.
This section was drafted by. Shanxi Provincial Medical Organization Library, China Food and Drug Inspection and 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 repair materials. Part 3. Demineralized bone
1 Scope
This part of YY/T 0513 specifies the terms and definitions, specifications, requirements, test methods, labels, instructions, packaging, transportation of demineralized bone
And storage requirements.
This section applies to demineralized bone products prepared from human bone tissue.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies 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. Genotoxicity, carcinogenicity and reproductive toxicity tests
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 response test after implantation
GB/T 16886.10 Biological evaluation of medical devices Part 10. Irritation and delayed-type 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 medical device immunotoxicology tests
GB/T 19633.1 Final Sterilized Medical Device Packaging Part 1. Requirements for Materials, Sterile Barrier System and Packaging System
YY 0033 Sterile medical device production management specification
YY 0236 Composite film for pharmaceutical packaging (general)
YY/T 1680-2020 Allogeneic repair material Demineralized bone material in vivo osteogenic induction performance
2015 Edition of the Pharmacopoeia of the People's Republic of China (Part 4)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Allogeneic bone repair material alogeneic bone grafts
Bone tissue obtained and prepared from different human beings.
3.2
Demineralisation
The process of removing minerals from tissues using hydrochloric acid or other substances.
3.3
Demineralized bone grafts
Demineralized bone repair materials.
Note. This section refers specifically to allogeneic bone repair materials.
Related standard: YY/T 0513.2-2020
Related PDF sample: YY/T 0606.9-2007    YY 0948-2015