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YY/T 0513.2-2020: (Allogeneic restorative materials - Part 2: Cryogenic frozen bone and freeze-dried bone)
Status: Valid YY/T 0513.2: Evolution and historical versions
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| YY/T 0513.2-2020 | English | 249 |
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(Allogeneic restorative materials - Part 2: Cryogenic frozen bone and freeze-dried bone)
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YY/T 0513.2-2020
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| YY/T 0513.2-2009 | English | 639 |
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Allogeneic bone grafts. Part 2: Deep-frozen allogeneic bone grafts and freeze-dried allogeneic bone grafts
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YY/T 0513.2-2009
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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) | | Classification of Chinese Standard | C45 | | Word Count Estimation | 13,127 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-06-01 | | Older Standard (superseded by this standard) | YY/T 0513.2-2009 | | Regulation (derived from) | Announcement No. 76 (2020) of the National Medical Products Administration | | Issuing agency(ies) | State Drug Administration | YY/T 0513.2-2020: (Allogeneic restorative materials - Part 2: Cryogenic frozen bone and freeze-dried bone)
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People's Republic of China Pharmaceutical Industry Standards
YY/T 0513.2-2020 replaces YY/T 0513.2-2009
Released on 2020-06-30
Implementation of 2021-06-01
Issued by the National Medical Products Administration
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) Method for measuring residual water content of freeze-dried bones 8
Reference 9
Foreword
YY/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 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 Medical Device Biological Evaluation Part 11.Systemic Toxicity Test" (see
Chapter 2, Chapter 2 of the.2009 Edition);
---Modified the term "freeze-dried bone", which is 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 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 external factors", in which 5.1 is changed to comply with 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
Chapter 5, 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 "moisture 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);
---Pyrogen test (see Chapter 6) and pyrogen test method (see Chapter 7) have been added to 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 requirements of "systemic acute toxicity test" (see Chapter 6) and the method of "systemic acute toxicity test" (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 the "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);
---The temperature and storage time limit requirements in "Packaging, Transportation and Storage" have been added, which are consistent with the STB standard (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 Allograft 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 "implant test" and "pH" (see Chapter 6, Chapter 7,
Appendix A and Appendix C of the.2009 edition);
---Appendix A is a normative appendix, and Appendix B and Appendix C are informative appendices (see Appendix A, Appendix B, Appendix C, the.2009 edition of the appendix
Record B, Appendix D, Appendix F);
---Modified C in Appendix C. 3.C. The content of 5 (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.
The previous editions of the standards replaced by this part are as follows.
Allogeneic restorative 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 specifications, raw material requirements and control of external factors, 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 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.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 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) The Pharmacopoeia of the People’s Republic of China (2015 edition four)
3 Terms and definitions
The following terms and definitions apply to this document.
4 Product categories, models and specifications
4.1 Classification
4.1.1 Divided into 3 categories according to the purpose. general type (non-structural bone graft), bony implants, large bone joints (structural bone graft), etc.
4.1.2 According to the processing technology, it can be divided into. freeze-dried bone (abbreviated as freeze-dried bone, code DG), and cryogenic frozen bone (abbreviated as deep-frozen bone, code SD).
4.1.3 According to the tissue structure and anatomy, it can be divided into cancellous bone, cortical bone, mixed bone (cortical cancellous bone), long bone, diaphysis, bone joint, etc.
4.1.4 According to the processed shape, it is divided into bone strips, bone blocks, bone plates, bone meal, bone nails, bone cages, etc.
4.2 Specifications
It should be marked by weight, volume or length, and special shapes should be marked with geometric dimensions.
5 Raw material requirements and control of external factors
5.1 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 Requirements
6.1 Specifications
The specifications of allogeneic bone products should not exceed ±10% of the marked value or meet the processing specifications proposed by the user.
6.2 Appearance
The appearance is white or slightly yellow, and the bone morphology and structure are clear. No bone marrow and blood components should be observed.
6.3 Density
Freeze-dried cancellous bone is 0.17g/cm3~0.45g/cm3, and freeze-dried cortical bone is 1.43g/cm3~2.23g/cm3.
6.4 pH
The pH of the product extract is between 5.5 and 7.5.
6.5 Water content
The residual water content of freeze-dried bone is less than 6% (weight loss method).
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.
YY/T 0513.2-2020
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 short-term subcutaneous implantation, select appropriate experimental animals in accordance with GB/T 168886.6, the test period is 12 weeks, and the tissue 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 should be no significant difference in pathology between the experimental 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...
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