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YY/T 0513.2-2020

Chinese Standard: 'YY/T 0513.2-2020'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0513.2-2020English259 Add to Cart Days<=3 (Allogeneic restorative materials Part 2: Cryogenic frozen bone and freeze-dried bone) Valid YY/T 0513.2-2020
YY/T 0513.2-2020Chinese17 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY/T 0513.2-2020 (YY/T0513.2-2020)
Description (Translated English) (Allogeneic restorative materials Part 2: Cryogenic frozen bone and freeze-dried bone)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Word Count Estimation 13,118
Date of Issue 2020-06-30
Date of Implementation 2021-06-01
Older Standard (superseded by this standard) YY/T 0513.2-2009
Regulation (derived from) Announcement No. 76 (2020) of the National Medical Products Administration

YY/T 0513:2-2020
(Allogeneic restorative materials Part 2: Cryogenic frozen bone and freeze-dried bone)
ICS 11:040:40
C45
People's Republic of China Pharmaceutical Industry Standard
Replace YY/T 0513:2-2009
Allogeneic restoration materials
Part 2: Cryogenic frozen bone and freeze-dried bone
2020-06-30 released
2021-06-01 implementation
Issued by the State Drug Administration
Table of contents
Preface Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Product classification, model and specification 1
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 allogeneic bone products 6
Appendix B (informative appendix) Allogeneic bone mineral density measurement method 7
Appendix C (informative appendix) Freeze-dried bone residual water measurement method 8
Reference 9
Preface
YY/T 0513 "Allogeneic Restorative Materials" is divided into the following parts:
---Part 1: The basic requirements of the organization library;
---Part 2: Deep cryogenic freezing bone and freeze-dried bone;
---Part 3: Demineralized bone:
This part is Part 2 of YY/T 0513:
This section was drafted in accordance with the rules given in GB/T 1:1-2009:
This part is a reference to YY/T 0513:2-2009 "Allogeneic bone repair materials Part 2: Cryogenic frozen bone and freeze-dried bone"
Revision: This part replaces YY/T 0513:2-2009: Compared with the original standard, the main technical changes except for editorial changes are as follows:
---The standard name was revised to "Allogeneic Restorative Materials Part 2: Cryogenic Frozen Bone and Freeze-dried Bone";
--- Deleted the expression "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 Citation GB/T 16886:11 Biological Evaluation of Medical Devices Part 11: Systemic Toxicity Test" (see
Chapter 2, Chapter 2 of the:2009 edition);
---Modified the term "freeze-dried bone" to be consistent with the Tissue Bank (STB) standard of the American Association of Tissue Banks (AATB) (see Chapter 3,
Chapter 3 of the:2009 edition);
--- Deleted "3:2, 3:3, 3:6, 3:7, 3:8, 3:9, 3:10" because it did not appear in the text (Chapter 3 of the:2009 edition);
---Modified "Specifications", no longer stipulate the specific minimum size of the product, and emphasized that the quantity and customized product size should be marked (see Chapter 4,
Chapter 4 of the:2009 edition);
--- Modify "raw material requirements" to "raw material requirements and control of external factors", in which 5:1 is changed to meet the requirements of Appendix A; 5:2 is correct
The regulatory requirements that should be met are added to the requirements of the production process; 5:3 is moved to the product biological evaluation part 6:7:5 (see section
Chapter 5, Chapter 6, Chapter 5 of the:2009 edition);
---Modified the content of the "specification" requirements (see Chapter 6, Chapter 6 of the:2009 edition);
---Modified the "water content" requirements, consistent with the AATB standard (see Chapter 6, Chapter 6 of the:2009 edition);
--- Advance the sterility requirement to 6:6 (see Chapter 6, Chapter 6 of the:2009 edition);
---Added pyrogen test (see Chapter 6) and pyrogen test method (see Chapter 7) in the biological evaluation;
---Modified the "implantation test", clarified the requirements and precautions for local implantation and long-term in situ implantation test (see Chapter 6,:2009
Chapter 6 of the edition);
---Added the requirements of "immunological test" (see Chapter 6) and the method of "immunological test" (see Chapter 7);
---Added the requirements of "intradermal reaction test" (see Chapter 6) and the method of "intradermal reaction test" (see Chapter 7);
---Added the "systemic acute toxicity test" requirements (see Chapter 6) and the "systemic acute toxicity test" method (see Chapter 7);
---Added the requirements of "sub-chronic toxicity test" (see Chapter 6) and the method of "sub-chronic toxicity test" (see Chapter 7);
--- Deleted "inspection rules" (Chapter 8 of the:2009 edition);
--- 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);
---Added the temperature and storage time limit requirements in "Packaging, Transportation, and Storage", consistent with STB standards (see Chapter 9,:2009 edition
Chapter 9);
---Modified the "packaging" content (see Chapter 9, Chapter 9 of the:2009 edition);
--- Deleted "Appendix A (informative appendix) reference specifications for allogeneic bone" (see Appendix A of the:2009 edition);
--- The original "Appendix C (informative appendix) test methods for allogeneic bone implantation" and "Appendix E (normative appendix) bone sample acid
Alkalinity test method", its related content is combined in the standard text "implantation test" and "pH" (see Chapter 6, Chapter 7,
Appendix A and Appendix C of the:2009 edition);
---Appendix A is a normative appendix, Appendices B and C are informative appendices (see Appendix A, Appendix B, Appendix C, the:2009 edition of the appendix
Record B, Appendix D, Appendix F);
---Modified the contents of C:3 and C:5 in Appendix C (see Appendix C, Appendix F of the:2009 edition):
Please note that certain 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 units 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:
The previous versions of the standards replaced by this part are as follows:
---YY/T 0513:2-2009:
Allogeneic restoration materials
Part 2: Cryogenic frozen bone and freeze-dried bone
1 Scope
This part of YY/T 0513 specifies the terms and definitions, product classification, model and specification, original
Material requirements and exogenous factors control, requirements, test methods, labels, instructions, packaging, transportation and storage requirements:
This section applies to cryogenic frozen bone and freeze-dried bone products prepared from human bone tissue:
2 Normative references
The 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 references, 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: 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: Irritation and Skin Sensitization 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 Test for Medical Devices
GB/T 19633:1 Terminally sterilized medical device packaging Part 1: Requirements for materials, sterile barrier systems and packaging systems
YY 0033 Sterile medical device production management specifications
YY 0236 Composite film for pharmaceutical packaging (general rules)
Pharmacopoeia of the People's Republic of China (2015 edition four)
3 Terms and definitions
The following terms and definitions apply to this document:
3:1
Allogeneic bone repair material alogeneicbonegrafts
Bone tissue obtained and prepared from different human individuals:
3:2
Deep-frozen bone grafts
Bone products stored in an environment below -40°C before and after preparation:
3:3
Freeze-dried bone grafts
A bone product with a residual water content of less than 6% (weightlessness method) after lyophilization:
4 Product classification, model and specifications
4:1 Classification
4:1:1 Divided into 3 categories according to the purpose: general (non-structural bone graft), bony endophytes, large segment bone joints (structural bone graft), etc:
Related standard: YY/T 0513.3-2020