Perfusable organs for transplantation

1.1 Purpose

This Standard addresses issues related to the safety of human perfusable organs used for transplantation. It includes quality system requirements and aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to, or affected by, the transplantation of perfusable organs.

1.2 Areas of application

This Standard applies to establishments (or facilities) and individuals involved in the following activities related to perfusable organs intended for transplantation:

a) processing;

b) evaluation of the safety of perfusable organs prior to transplantation;

c) recordkeeping;

d) error, accident, and adverse reaction reporting;

e) distribution;

f) importation or exportation; and

g) recall of human organs intended for transplantation.

1.3 Inclusions

This Standard is intended to serve as a benchmark and provide minimum requirements for the verification of safe practices in each of the activities listed in Items a) to g) in Clause 1.2.

Note: Examples of establishments or individuals include the following:

a) organ donation organizations (ODOs);

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

c) HLA laboratories.

1.4 Limitations

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

1.5 Priority

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