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YY/T 0606.12-2007 English PDF

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YY/T 0606.12-2007: Tissue engineered medical products. Part 12: Guide for processing cells, tissues, and organs
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0606.12-2007English339 Add to Cart 3 days [Need to translate] Tissue engineered medical products. Part 12: Guide for processing cells, tissues, and organs Valid YY/T 0606.12-2007

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Basic data

Standard ID YY/T 0606.12-2007 (YY/T0606.12-2007)
Description (Translated English) Tissue engineered medical products. Part 12: Guide for processing cells, tissues, and organs
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 13,187
Date of Issue 2007-01-31
Date of Implementation 2008-01-01
Regulation (derived from) Chinese industry standards for record 2007 of 4 (total of 88)
Issuing agency(ies) State Food and Drug Administration
Summary This standard provides for Tissue Engineered Medical Products (TEMPs) cells, tissues and organs processing, testing, production, and quality assurance requirements, including: a) cells, tissues and organs processed (ie: Facilities, Reagents, the receiving program, inspection and storage, tissue culture constituents, biological risk factors, and the operation area), b) for the body (human or non-human source) and screening, c) cells, tissues and organs of the test and processing. This section does not apply to the Drug Administration Law, in accordance with the existing products for the management of biological products.

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