YY/T 0954-2026Nonactive surgical implants - Type I collagen implants (English PDF)
无源外科植入物 I型胶原蛋白植入剂
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2026
Implementation date
March 1, 2027
Scope
YY/T 0954-2026 is the English-translated version of 无源外科植入物 I型胶原蛋白植入剂.
YY/T 0954 is the product standard for injectable and implantable type I collagen, the material used in soft tissue augmentation, dermal filling and tissue repair. As a standard for a non-active surgical implant it addresses the material and the finished implant together, since with collagen the two cannot be separated: the source tissue, the extraction route and the crosslinking determine what the implant does in the body. It is the finished-product counterpart to YY/T 1985 on collagen as a tissue engineering raw material, revised in the same period. For a manufacturer of collagen fillers or collagen-based implants seeking registration in China, this is the standard the product specification is written against, and for a foreign supplier it is the document a Chinese partner will cite when qualifying the material.
Document preview — YY/T 0954-2026
National Standard of the People's Republic of China
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
Foreword
This document was issued on 9 March 2026 by the National Medical Products Administration and takes effect on 1 March 2027.
It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.
1 Scope
YY/T 0954 is the product standard for injectable and implantable type I collagen, the material used in soft tissue augmentation, dermal filling and tissue repair. As a standard for a non-active surgical implant it addresses the material and the finished implant together, since with collagen the two cannot be separated: the source tissue, the extraction route and the crosslinking determine what the implant does in the body. It is the finished-product counterpart to YY/T 1985 on collagen as a tissue engineering raw material, revised in the same period. For a manufacturer of collagen fillers or collagen-based implants seeking registration in China, this is the standard the product specification is written against, and for a foreign supplier it is the document a Chinese partner will cite when qualifying the material.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
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YY/T 0954-2026
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