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YY/T 1955-2025Tissue engineering medical device - Collagen - Terminology (English PDF)

组织工程医疗器械胶原蛋白术语

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 26, 2025

Implementation date

March 1, 2026

Scope

YY/T 1955-2025 is the English-translated version of 组织工程医疗器械胶原蛋白术语.

YY/T 1955-2025 is the Chinese standard "Tissue engineering medical device - Collagen - Terminology". Its scope clause reads: This document defines the terms and definitions of collagen.

This document applies to collagen for the preparation of tissue engineering scaffold materials and their medical device products, including tissue extraction or genetic recombination Collagen.

This document does not apply to genetically modified collagen without a triple helix structure. Its clauses include terms and definitions.

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Document preview — YY/T 1955-2025

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C30

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions
3.

1 Scope

This document defines the terms and definitions of collagen.

This document applies to collagen for the preparation of tissue engineering scaffold materials and their medical device products, including tissue extraction or genetic recombination

Collagen.

This document does not apply to genetically modified collagen without a triple helix structure.

2 Normative references

This document has no normative references.

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Collagen

Collagen

A family of secretory proteins containing at least 20 genetically distinct types that primarily provide structural support for the body.

A unique triple helical structure consisting of three polypeptide chains (called alpha chains) with certain biological functions.

[Source. YY/T 1849-2022, 3.1]

3.2 Collagen polymer

Without the introduction of exogenous substances (such as cross-linking agents), collagen molecules are self-assembled or polymerized to form a polymer with a high-level structure.

Compound.

3.3

The specific amino acid sequence of the triple helical structure of collagen is the basic sequence of the triple helical structure of natural collagen, usually "glycine-

Proline-Hydroxyproline-"􀰷(Gly-XY)􀰺.

3.4 Propeptide

The amino- and carboxyl-terminal non-trimeric residues of individual collagen polypeptide chains (alpha chains) that direct triple helical folding and procollagen molecule formation

Helical structure area.

NOTE. Removal of propeptides is required for collagen fibril formation and self-assembly.

3.5 Tropocollagen

The collagen molecule consists of three alpha chains with the amino- and carboxyl-terminal propeptides removed (see Figure 1); the carboxyl- and amino-terminal telopeptides remain.

whole.

Note. Tropocollagen can self-assemble to form a fibrotic network.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

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