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YY/T 0606.13-2008Tissue engineered medical products - Part 13: Standard test method for automated cell counting (English PDF)

组织工程医疗产品第13部分：细胞自动计数法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

April 25, 2008

Implementation date

June 1, 2009

Scope

YY/T 0606.13-2008 is the English-translated version of 组织工程医疗产品第13部分：细胞自动计数法.

Manual counting on a haemocytometer carries an operator-dependent variability that is tolerable in research and not in manufacture, which is what makes an automated method with a defined procedure necessary.

The standard sets out how such counting is performed and validated for tissue engineered products. It is the counting counterpart of YY/T 1562 on cell viability in the same family of scaffold and cell evaluation methods.

For a manufacturer of cell-based or cell-seeded products for the Chinese market, this is the method behind the cell number on the label.

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Document preview — YY/T 0606.13-2008

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C45

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

This document was issued on 25 April 2008 by the National Medical Products Administration and takes effect on 1 June 2009.

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 0606.13 is Part 13 of the Chinese tissue engineered medical product series and covers automated cell counting. For a cell-containing product, the cell count is a release specification: it is the dose. Manual counting on a haemocytometer carries an operator-dependent variability that is tolerable in research and not in manufacture, which is what makes an automated method with a defined procedure necessary. The standard sets out how such counting is performed and validated for tissue engineered products. It is the counting counterpart of YY/T 1562 on cell viability in the same family of scaffold and cell evaluation methods. For a manufacturer of cell-based or cell-seeded products for the Chinese market, this is the method behind the cell number on the label.

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 — 15 pages — is available in the English PDF.

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