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YY/T 0606.12-2007Tissue engineered medical products - Part 12: Guide for processing cells, tissues and organs (English PDF)

组织工程医疗产品第12部分：细胞、组织、器官的加工处理指南

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Issued by

State Food and Drug Administration

Level / Type

Industry · Recommended

Issue date

January 31, 2007

Implementation date

January 1, 2008

Scope

YY/T 0606.12-2007 is the English-translated version of 组织工程医疗产品第12部分：细胞、组织、器官的加工处理指南.

YY/T 0606.12 is Part 12 of the Chinese tissue engineered medical product series and guides the processing of cells, tissues and organs.

It covers the handling steps between recovering biological material and having a product: procurement, transport, processing, storage and the controls that keep the material sterile, viable and traceable through all of them.

Processing is where a tissue-based product is made or lost, because the same donor material can yield an implant that works or one that provokes a response, depending on how it was decellularised, preserved and handled.

For a manufacturer working with donor tissue or cells for the Chinese market, this is the guidance the processing procedures and their validation are built on.

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Document preview — YY/T 0606.12-2007

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C45

Issued by: State Food and Drug Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Terms and definitions

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 0606.12 is Part 12 of the Chinese tissue engineered medical product series and guides the processing of cells, tissues and organs. It covers the handling steps between recovering biological material and having a product: procurement, transport, processing, storage and the controls that keep the material sterile, viable and traceable through all of them. Processing is where a tissue-based product is made or lost, because the same donor material can yield an implant that works or one that provokes a response, depending on how it was decellularised, preserved and handled. For a manufacturer working with donor tissue or cells for the Chinese market, this is the guidance the processing procedures and their validation are built on.

Remaining clauses in the full document

2 Normative references
3 Terms and definitions

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.

Referenced standards

Cited by

YY/T 1788-2021Implants for surgery-General requirements for animal-derived patch products

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