Draft Details

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.

1.6 Terminology

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.

Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.