Ocular tissues for transplantation

1.1 Purpose

This Standard addresses issues related to the safety of human ocular tissues used for transplantation purposes. It includes aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to or affected by the transplant of ocular tissues.

1.2 Inclusions

This Standard applies to eye banks and other establishments and to individuals involved in the following activities related to ocular tissues intended for transplantation:

a) processing;

b) storage;

c) evaluation of the safety of ocular tissues prior to transplantation;

d) record-keeping;

e) error, accident, and adverse reaction investigation and reporting;

f) distribution;

g) importation or exportation; and

h) complaints and recalls.

1.3 Limitations

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

1.4 Priority

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