YY/T 0606.3-2007Tissue engineered medical products - Part 3: General classification (English PDF)
组织工程医疗产品 第3部分：通用分类
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 31, 2007
Implementation date
January 1, 2008
Scope
YY/T 0606.3-2007 is the English-translated version of 组织工程医疗产品 第3部分：通用分类.
YY/T 0606.3 is Part 3 of the Chinese tissue engineered medical product series and sets out the general classification for the field. Tissue engineered products sit awkwardly between devices, biologics and cell therapies, and a classification is what determines which requirements apply to a given product: a scaffold alone, a scaffold seeded with cells, and a cell preparation with no scaffold raise different questions and different evidence. As the earliest part of a series that now runs to more than a dozen documents, it established the framework that YY/T 1995, YY/T 1985 and the other tissue engineering standards fit into. For a manufacturer developing a tissue engineered product for China, this is where the regulatory classification of the product starts.
Document preview — YY/T 0606.3-2007
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C45
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 31 January 2007 by the National Medical Products Administration and takes effect on 1 January 2008.
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.
It is classified under ICS 11.040.40, Chinese classification C45.
1 Scope
YY/T 0606.3 is Part 3 of the Chinese tissue engineered medical product series and sets out the general classification for the field. Tissue engineered products sit awkwardly between devices, biologics and cell therapies, and a classification is what determines which requirements apply to a given product: a scaffold alone, a scaffold seeded with cells, and a cell preparation with no scaffold raise different questions and different evidence. As the earliest part of a series that now runs to more than a dozen documents, it established the framework that YY/T 1995, YY/T 1985 and the other tissue engineering standards fit into. For a manufacturer developing a tissue engineered product for China, this is where the regulatory classification of the product starts.
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 — 16 pages — is available in the English PDF.
Referenced standards
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Related Standards
YY/T 0606.10-2008 — Tissue engineered medical products - Part 10: Guide for in vivo assessment of implants for repair or regeneration of articular cartilage
YY/T 0606.12-2007 — Tissue engineered medical products - Part 12: Guide for processing cells, tissues and organs
YY/T 0606.13-2008 — Tissue engineered medical products - Part 13: Standard test method for automated cell counting
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YY/T 0606.3-2007
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