YY/T 0513.3-2020Allogeneic grafts - Part 3: Demineralized 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 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).

1 Scope

This 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 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: 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 definitions

The following terms and definitions apply to this document.

4 Specifications

It should be marked by weight and volume, 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

7 Test method