Standard No.:	YY/T 1955-2025
English Name:	Tissue engineering medical device—Collagen—Terminology
Chinese Name:	组织工程医疗器械 胶原蛋白 术语
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	NMPA
Issued on:	2025-02-26
Implemented on:	2026-3-1
Status:	to be valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	165.0
Delivery:	via email in 1 business day

YY/T 1955-2025 Tissue engineering medical device – Collagen - Terminology 1 Scope This document defines the terms and definitions of collagen. This document is applicable to the collagen (including collagen prepared by tissue extraction or genetic recombination) for preparing tissue engineering scaffold materials and related medical device products. This document is not applicable to the collagen prepared by genetic recombination and without a triple helix structure. 2 Normative references No normative references are listed in this document. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 collagen secreted protein family containing at least 20 genetically different types, mainly playing a structural support role in the body, having a unique triple helix configuration composed of three polypeptide chains (referred to as α chains), and having certain biological functions [Source: YY/T 1849-2022, 3.1] 3.2 collagen polymer polymer with advanced structure formed by collagen molecules through self-assembly or polymerization, without introducing exogenous substances (such as cross-linking agents) 3.3 collagen mimetic peptide specific amino acid sequence of the triple helix structure of collagen, the basic sequence of the triple helix configuration of natural collagen, generally “glycine-proline-hydroxyproline” [(Gly-X-Y)] 3.4 propeptide non-triple helix structural region at the amino terminus and carboxyl terminus of a single collagen polypeptide chain (α chain) that guide triple helix folding and the formation of procollagen molecules Note: The propeptide needs to be removed during the formation and self-assembly of collagen fibrils. 3.5 tropocollagen collagen molecule composed of three α chains with the amino- and carboxyl-terminal propeptides removed (see Figure 1); with intact carboxyl-terminal and amino-terminal telopeptides Note: The tropocollagen can self-assemble to form a fibrous network. 3.6 procollagen collagen molecule composed of three carboxylated polypeptide chains (α chains), in which the amino-terminal propeptide and the carboxyl-terminal propeptide of the polypeptide chain remaining intact (see Figure 1).

Foreword i 1 Scope 2 Normative references 3 Terms and definitions Bibliography Index