This Standard specifies general requirements related to the safety of human cells, tissues, and organs used for transplantation and assisted reproduction purposes. It includes aspects of safety for potential and actual donors and recipients, personnel, and others who may be exposed to or affected by the transplantation of cells, tissues, or organs. This Standard is intended to serve as a benchmark and provide minimum requirements for the verification of safe practices in the donor suitability assessment, retrieval, processing, preservation, packaging, labelling, storage, quarantine, evaluation, recordkeeping, adverse event reporting, distribution, importation or exportation, and recall of human cells, tissues, and organs for transplantation and assisted reproduction.
This Standard applies to establishments (or facilities) and individuals involved in the donor suitability assessment, retrieval, processing, preservation, packaging, labelling, storage, quarantine, evaluation, recordkeeping, adverse event reporting, distribution, importation or exportation, and recall of human cells, tissues, and organs intended for transplantation or assisted reproduction. Note: Examples of establishments (or facilities) or individuals include the following:
a) organ donation organizations;
b) tissue retrieval organizations;
c) tissue banks;
d) cell or tissue processing facilities;
e) cell culture laboratories;
f) histocompatibility laboratories;
g) transplant programs and facilities (e.g., hospitals and special clinics);
h) programs for lymphohematopoietic cells, including clinical programs, retrieval facilities, and processing facilities;
i) centres for assisted reproduction, including facilities using assisted reproduction techniques or procedures, and facilities providing related laboratory services;
j) health care professionals;
k) designated importers and exporters;
l) distributors; and
m) other cell-, tissue-, and organ-dispensing services.
This Standard and its subset Standards (i.e., the Z900 series of Standards) are not intended to replace detailed specifications and standard operating procedures but are intended to be used in their preparation.
This Standard and its subset apply to human cells, tissues, and organs retrieved from a living or dead body and intended for transplantation or assisted reproduction into humans but do not apply to the following:
a) whole blood, blood components (i.e., red blood cells, granulocytes, platelets, plasma, and cryoprecipitate), and blood products (i.e., therapeutic products derived from plasma);
b) human milk and other excreted or secreted substances; and
c) autologous cells, tissues, and organs that are not extensively manipulated, altered, or stored.
Note: Some requirements in this Standard may apply to human cellular and tissue-based products.
Subset Standards have been developed for cells, tissues, and organs (see Clause 2). Where an applicable subset Standard exists, this Standard is to be used in conjunction with that subset Standard. Where a subset Standard exists and its requirements differ from this Standard's requirements, the subset Standard applies. Where no subset Standard exists, this Standard applies.
In this Standard, shall is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; should is used to express a recommendation or that which is advised but not required; and may is used to express an option or that which is permissible within the limits of the standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements.