YY/T 0606.12-2007 Active
YY/T 0606.12-2007 Tissue engineered medical products—Part 12:Guide for processing cells,tissues,and organs
Abstract
1.1 This part of YY/T 0606 specifies the requirements for the processing, testing, production, and quality assurance of cells, tissues, and organs used in tissue engineering medical products (TEMPs), including: a) Processing of cells, tissues, and organs (i.e., facilities, reagents, reception procedures, inspection, and storage; tissue culture components, biological hazard factors, and operating areas); b) Donors (human or non-human) and screening; c) Testing and processing of cells, tissues, and organs. 1.2 This part does not apply to products that are managed as biological products according to the current Pharmaceutical Administration Law.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 0606.12-2007 |
| CCS | Extracorporeal circulation, artificial organs, and prosthetic devices |
| ICS | Surgical implants, prostheses, and orthoses |
| Implement Date | 2008-01-01 |