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YY/T 1453-2016: Tissue engineering medical device products--Methods for determination of type Ⅰ collagen
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YY/T 1453-2016: Tissue engineering medical device products--Methods for determination of type Ⅰ collagen

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Tissue engineering medical device products - Methods for determination of type I collagen ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Tissue engineering medical equipment products Characterization of type Ⅰ collagen 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 Test method for type Ⅰ collagen Appendix A (normative) Determination of purity of type Ⅰ collagen 4 Appendix B (normative) Determination of hydroxyproline content 6 Appendix C (normative) Melting point determination 9 Appendix D (normative) Trace element analysis 10 Appendix E (normative appendix) Determination of total sugar content 11 GB/T 1453-2016

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. And the normative reference in this standard international documents are consistent with the relationship between China's documents are as follows. GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (ISO 10993-1..2009, IDT). This standard is proposed by the State Food and Drug Administration. This standard by the National Surgical Implant and Orthopedic Equipment Standardization Technical Committee Organizational Engineering Medical Device Products Subcommittee (SAC/TC110/SC3). The drafting unit of this standard. China Food and Drug Administration Research Institute. The main drafters of this standard. Ke Linnan, Fang Yu, Fu Bufang, Wang Jian, Huang Yuanli, Duan Xiaojie, Chen Dandan, Feng Xiaoming, Wang Chunren. GB/T 1453-2016 Tissue engineering medical equipment products Characterization of type Ⅰ collagen

1 Scope

This standard specifies the test methods for the preparation of type I collagen for tissue engineering medical device products. This type of prescription is prescribed by this standard Collagen includes I derived from tissue, such as skin, tendons, bones, etc., extracted, isolated and purified, or other sources Type collagen.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. Food safety - Determination of total arsenic and inorganic arsenic in national standard foodstuffs GB 5009.11-2014 Food safety - Determination of total mercury and organic mercury in national foodstuffs GB 5009.17-2014 GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (ISO 10993-1, IDT) GB/T 22223-2008 Determination of total fat, saturated fats (acids), unsaturated fats (acids) in food - Hydrolysis - Gas phase color Spectrum method Pharmacopoeia of the People's Republic of China (2015)

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Type Ⅰ collagen type Ⅰcolagen The most abundant collagen protein, which is expressed in the mammalian tissue by the COL1A1 gene encoding the alpha chain and the COL1A2 gene, In fibrous collagen. Note 1. The peptide chain of type I collagen consists of repeating glycine-XY (proline often occupies X-position, hydroxyproline occupies Y position) amino acid sequence. Type Ⅰ collagen is rich in glycine (Gly), L-alanine (L-Ala), L-proline (L-Pro) and 4-hydroxyproline (4-Hypro) And does not contain L-tryptophan (L-Try). Note 2. Collagen has three alpha chains formed by three helices. In the case of heating (eg, above 60 ° C) the collagen α chain triple helix structure is irreversible Denatured into a single alpha chain and some beta and gamma bands (ie gelatin). Note 3. often associated with type Ⅰ collagen type Ⅲ collagen and Ⅴ collagen, in addition to non-collagen-like proteins such as elastin and other structural molecules (amino Polysaccharides, lipoproteins and glycoprotein complexes). 3.2 Exogenous factor adventitiousagents Contaminants present in type I collagen, including bacteria, fungi, mycoplasma and exogenous viruses. These substances may be inadvertently The ground is introduced into the production process and the final product. GB/T 1453-2016 ...