ADA TR 1089-2016

Track and Trace for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)


 

 

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标准号
ADA TR 1089-2016
发布单位
美国国家标准学会
替代标准
ADA TR 1089-2019
当前最新
ADA TR 1089-2019
 
 
适用范围
This technical report defines inventory management requirements in dental practices for HCT/Ps to ensure traceability from the donor to the recipient and the recipient to the donor. Its intent is also to facilitate reporting of potential adverse reactions, including disease transmission, to all parties involved in processing the HCT/P. This technical report should be used in conjunction with ADA SCDI TR 1081, Track and Trace for Implantable Devices and Biologics, which addresses HCT/P’s regulated as medical devices which are covered under the FDA’s Unique Device Identifier (UDI) final rule.

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