YY/T 0606.12-2007 Active Industry standards-Medicine

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

Publish Date: 2007-01-31 Implement Date: 2008-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0606.12-2007

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2007-01-31

Implement Date: 2008-01-01

Pages: 12 pages

Scope

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.