GB/T 36988-2018

Active

Guidance for good tissue practice of human origin for tissue engineered medical products

组织工程用人源组织操作规范指南

Standard Type
GBT
ICS
11.040.40
CCS
C45
Status
Active
Issue Date
2018-12-28
Implementation
2021-01-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard provides operational guidelines for the procurement, processing, storage, and quality control of human-derived tissues used in tissue-engineered medical products. It is applied in healthcare and biomedical manufacturing settings to ensure the safety, traceability, and ethical handling of human tissues during the production of implants or regenerative therapies. The standard is particularly relevant for manufacturers, clinical research institutions, and regulatory bodies involved in developing or evaluating tissue-engineered products for human use.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.