YY/T 1950-2024Tissue engineering medical device - Silk fibroin (English PDF)
组织工程医疗器械 丝素蛋白
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 29, 2024
Implementation date
October 15, 2025
Scope
YY/T 1950-2024 is the English-translated version of 组织工程医疗器械 丝素蛋白.
YY/T 1950-2024 is the Chinese standard "Tissue engineering medical device - Silk fibroin".
Its scope clause reads: This document specifies the performance requirements of silk fibroin used in tissue engineering medical device products, as well as the labeling, packaging, transportation and storage. requirements and describes the corresponding test methods.
This document applies to silk fibroin for the preparation of tissue engineering medical device products. Note 1.The silk fibroin referred to in this document is the product obtained by removing the sericin from the cocoon layer or raw silk of natural silkworms (i.e. natural silk fibroin fiber).
Products obtained by processes such as degumming, dissolution and regeneration (i.e. regenerated silk fibroin). It does not include silk fibroin obtained by genetic engineering or genetic modification. protein.
Note 2.For silk fibroin used in other surgical implants or dressing products, refer to this document. Its clauses include terms and definitions.
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Document preview — YY/T 1950-2024
National Standard of the People's Republic of China
- ICS
- 11.030.30
- Classification
- C30
Issued by: National Medical Products Administration
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Categories
- 5 Requirements for Animal Origin Materials
- 6 Performance requirements
- 7 Test methods
- 8 Stability
- 9 Packaging, transportation and storage
- Appendix A (Informative) Research progress on basic structural characteristics and preparation methods of silk fibroin
- Appendix B (Normative) Determination of Molecular Weight of Regenerated Silk Fibroin---Rheological Method
1 Scope
This document specifies the performance requirements of silk fibroin used in tissue engineering medical device products, as well as the labeling, packaging, transportation and storage.
requirements and describes the corresponding test methods.
This document applies to silk fibroin for the preparation of tissue engineering medical device products.
Note 1.The silk fibroin referred to in this document is the product obtained by removing the sericin from the cocoon layer or raw silk of natural silkworms (i.e. natural silk fibroin fiber).
Products obtained by processes such as degumming, dissolution and regeneration (i.e. regenerated silk fibroin). It does not include silk fibroin obtained by genetic engineering or genetic modification.
protein.
Note 2.For silk fibroin used in other surgical implants or dressing products, refer to this document.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 16886 (all parts) Biological evaluation of medical devices
GB/T 32016 Determination of amino acids in silk
FZ/T 40006 Test method for oil content of silk
SN/T 2843 Determination of rubber content in raw silk
YY/T 0771.1 Medical devices of animal origin Part 1.Application of risk management
YY/T 0771.2 Medical devices of animal origin Part 2.Control of sources, collection and disposal
YY/T 0771.3 Medical devices of animal origin Part 3.Removal and inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents confirm
YY/T 1465 (all parts) Methods for evaluating the immunogenicity of medical devices
Pharmacopoeia of the People's Republic of China 2020 Edition
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Silk fibroin
Fibrous silk protein synthesized and secreted by the posterior silk gland of the silkworm.
Note. The core protein in mulberry silk fiber consists of a heavy chain (H chain protein) with a theoretical molecular mass of about 391 kDa, a light chain (L chain protein) of 25 kDa and a kDa or 27kDa P25 (also called fiber hexamer), the amount ratio of H chain protein, L chain protein and P25 protein is 6.6.1.
The heavy chain and light chain are connected by a single disulfide bond. P25 is a glycoprotein containing asparagine (ASN) oligosaccharide chains. P25 is connected to the heavy chain and light chain by a disulfide bond.
They are bound by non-covalent bonds such as hydrophobic bonds.
3.2 Regenerated Silk Protein
Silk core fiber (fibroin fiber) dissolves the protein mixture after desalting.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 32016Silk — Determination of amino acids
- YY/T 0771.1Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- YY/T 0771.2Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
- YY/T 0771.3Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
GB/T 16886
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.10-2024 — Biological evaluation of medical devices - Part 10: Tests for skin sensitization
GB/T 16886.11-2021 — Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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