CAN/CSA-Z900.2.4:22

Preface This is the fourth edition of CAN/CSA-Z900.2.4, Ocular tissues for transplantation . It supersedes the previous editions published in 2017, 2012, and 2003. This Standard is part of a series of management system StandardDetails 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) A requirement concerning travel history has been added in Clause 12.5. b) An exclusion regarding persons with an active Zika virus infection in the past 6 months has been added to Clause 13.1.3; also, the exclusion of persons with a medical diagnosis of a West Nile virus infection in the past 120 days has been incorporated into Clause 13.1.3. c) A note about determination of inactive leukemia or lymphoma has been added to Clause 13.1.3. d) Specific contraindications regarding corneal tissue for non-optical graft and keratoprosthesis have been added in Clause 13.1.6.2. e) The inclusion of a note in the PK (Clause 13.1.4), lamellar grafts (Clause 13.1.5.1.1), limbal grafts (Clause 13.1.5.2), scleral tissue (Clause 13.1.6.1), and non-optical graft and keratoprosthesis (Clause 13.1.6.2) clauses has been provided to clarify how the eye bank responsible for the evaluation of ocular tissue should define the corneoscleral disc minimum surgical suitability criteria within their SOPs. f) New sample collection requirements for deceased donors have been added in Clause 14.2.1.4. g) Post-processing slit-lamp biomicroscopy has been added for eye bank processed tissue in Clause 14.2.3.1.1. h) Clear zone delineation has been added in Clause 14.2.3.1.2. i) Povidone-iodine disinfection has been added in Clause 15.3.5. j) The information required on the forms accompanying tissue has been updated (Clause 16.4). k) The statement attached to tissue provided for purposes other than surgery has been updated (Clause 16.5.1). CSA Group acknowledges that the development of this Standard was made possible, in part, by the financial support of Health Canada. This Standard was prepared by the Subcommittee on Ocular Tissues, under the jurisdiction of the Technical Committee on Safety of Cells, Tissues, and Organs for Transplantation and Assisted Reproduction and the Strategic Steering Committee on Health Care Technology and Systems, and has been formally approved by the Technical Committee. This Standard has been developed in compliance with StandardDetails Council of Canada requirements for National StandardDetails of Canada. It has been published as a National Standard of Canada by CSA Group. Scope 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. 1.5 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.