T/LNSI 003-2023 Specifications for preparation, freezing, and resuscitation of human amniotic tissue

Scope

Scope: This document specifies the standardized operations and recommended methods for the preparation, cryopreservation, and resuscitation of human amniotic tissue. This document is applicable to medical institutions conducting the preparation, cryopreservation, and resuscitation of human amniotic tissue. Main technical content: 5 Human amniotic tissue preparation 5.1 Collection of human amniotic tissue samples 5.2 Storage and transportation of human amniotic tissue samples 5.3 Preparation of human amniotic tissue 6 Cryopreservation of human amniotic tissue The above-mentioned human amniotic tissue slices are stored frozen at -20 to -80°C in a deep-freeze refrigerator. 7 Resuscitation of human amniotic tissue During the resuscitation of human amniotic tissue, other processing of the amniotic tissue is carried out after removing the cryopreservation solution. 8 Data management The detailed information of the human amniotic tissue after cryopreservation is entered into a computer database, and a complete data archive is established for query. 9 Waste disposal Follow the "Regulations on the Management of Medical Waste" to dispose of it to designated locations properly. For used or unqualified human amniotic tissue, it must be disposed of in strict accordance with the procedures for handling biological samples. 10 Quality control

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