scope:

This Standard addresses issues related to the safety of human perfusable organs used for transplantation 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 transplant of perfusable organs.

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 organs intended for transplantation, including

a) organ donation organizations (ODOs);

b) transplant programs and facilities (hospitals and special clinics); and

c) histocompatibility laboratories.

This Standard is not intended to replace detailed specifications and standard operating procedures but is intended to be used in their preparation.

This Standard contains particular requirements for perfusable organs for transplantation and is intended to be used with the Z900.1 general requirements Standard. Where differences exist, the requirements of this Standard apply.

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.