YY/T 0513.2-2020Allogeneic grafts - Part 2: Deep-frozen bone grafts and freeze-dried bone grafts (English PDF)

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).

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 document. 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

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