See generic requirements in section A.4.1.1.
See generic requirements in section A.220.127.116.11.
Amniotic membranes should be collected only from living donors as part of a planned caesarean section of the donor.
Donor placentas are removed by medical staff at a gynaecological clinic as part of a planned caesarean section of the donor. Staff performing the retrieval is to be dressed appropriately for the kind of retrieval so as to minimize the risk of contamination of the tissue to be removed and any hazard for the performing staff. This includes due disinfection (surgical hand disinfection), sterile clothes as well as wearing sterile gloves, face mask or protective mask and surgery cap.
See generic requirements in section A.4.1.4.
The quality control tests on amniotic membrane grafts should consider at least the following minimum quality criteria:
a) Absence of transmissible disease agents and malignant cells;
b) Integrity (to provide barrier function);
c) Accurately sized pieces and clean edges.
See generic requirements in section A.5.1.4.
See generic requirements in section A.4.1.5.
See generic requirements in section A.18.104.22.168.
Following retrieval, the obtained donor placentas are to be packaged in such a way that the contamination risk is minimized. For this purpose, sterile pouches / packs are suitable.
See generic requirements in section A.22.214.171.124.
See generic requirements in section A.2.3.6.
The donor placentas are to be stored at appropriate temperatures to maintain their characteristics and biological functions. The storage (and transport) time of donor placentas should be kept as short as possible, and a temperature of 40°C should not be exceeded.
The following minimal storage conditions necessary to maintain the required biological properties of the donor placenta / human amniotic membrane should be adhered to:
a) Transport time of the placenta from the operating room (OR) to the tissue bank less than 1 hour: temperature of 2-40 °C to be maintained;
b) Transport time of the placenta from the OR to the tissue bank - 1-48 hours: transport at an appropriate environmental temperature to ensure tissue safety / stability, e.g. by use of cooling elements;
c) Placenta storage until earliest preparation: temperature of +2-10°C to be maintained, e.g. in the refrigerator, in which case preparation should be carried out no later than six (6) hours after retrieval;
d) Placenta storage until earliest preparation: temperature -75°C to -85°C to be maintained (in freezer), in which case preparation should be carried out no later than six (6) months after retrieval.
The donor placental tissues are to be transported at appropriate temperatures to maintain their characteristics and biological functions. Principally these temperatures correspond to the storage temperatures (see chapter C.126.96.36.199.).
The package and the mode of transport are to be chosen in a way as to ensure maintenance of the tissue-specific storage temperatures (see chapter C.188.8.131.52). This is to be monitored by the tissue bank at regular intervals. If temperature stability should not be reliably guaranteed by the pack or mode of transport used, also in cases of unexpectedly high or low environmental temperatures, a temperature recording unit is to be enclosed that is to measure the temperature inside the pack in minimally half-hour intervals and the data saved. In addition, the pack is to prevent contamination by persons in charge of tissue packaging and transport.
The transport time of donor placentas should be kept as short as possible.
See generic requirements in section A.4.1.7.