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YY/T 1453-2016Tissue engineering medical device products--Methods for determination of type I collagen (English PDF)

组织工程医疗器械产品 I型胶原蛋白表征方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 29, 2016

Implementation date

June 1, 2017

Scope

YY/T 1453-2016 is the English-translated version of 组织工程医疗器械产品 I型胶原蛋白表征方法.

YY/T 1453-2016 is the Chinese pharmaceutical industry standard that gives the test methods for characterizing type I collagen prepared for tissue engineering medical device products, whether extracted, separated and purified from tissue such as skin, tendon or bone, or obtained from other sources.

Its normative appendices set out how to determine the purity of the collagen, the hydroxyproline content, the melting point, trace elements and the total sugar content, drawing on the Pharmacopoeia of the People's Republic of China and on GB/T food analysis methods for arsenic, mercury and fats.

It also defines type I collagen and the adventitious agents - bacteria, fungi, mycoplasma and viruses - that may be introduced during production, and refers biological evaluation to GB/T 16886.1. Issued on 29 July 2016, it has applied since 1 June 2017.

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Document preview — YY/T 1453-2016

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C 35

Issued by: National Medical Products Administration of the People's Republic of China

Preface
1 Scope
2 normative reference document
3 Terms and definitions
Appendix A (normative) Determination of purity of type I collagen
Appendix B (normative) Determination of hydroxyproline content
Appendix C (normative) Melting point determination
Appendix D (normative) Trace element analysis
Appendix E (normative appendix) Determination of total sugar content

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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 alpha 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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 22223-2008

Cited by

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