scope:

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.

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.

Limitations

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

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

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.