CAN/CSA-Z900.2.3-17:2017 Edition

Preface

This is the third edition of CAN/CSA-Z900.2.3, Perfusable organs for transplantation. It supersedes the previous editions published in 2003 and 2012.

This Standard is part of a series of management system standards related to the safety of cells, tissues, and organs for transplantation and assisted reproduction. It was developed from work initiated by Health Canada’s Expert Working Group on Safety of Organs and Tissues for Transplantation.

Major changes to this edition include the following:
a) donor history related to West Nile virus has been updated
b) donor advocate has been clarified in Clause 12.2.3
c) exclusion of islet cells haven been updated in Clause 15.4 and
d) a new informative Annex summarizing exceptional distribution criteria has been added.

CSA Group gratefully acknowledges that the development of this Standard was made possible, in part, by the financial support of Health Canada.

Scope

1.1
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
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
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) histocompatibility laboratories.

1.4
This Standard is not intended to replace detailed specifications and standard operating procedures but is intended to be used in their preparation.

1.5
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
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.