CSA Group Ocular tissues for transplantation

Preface This is the third edition of CAN/CSA-Z900.2.4, Ocular tissues for transplantation. It supersedes the previous editions published in 2012 and 2003.  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) terminology has been updated;  b) donor screening has been updated, notably the exclusion criteria in Clause 13.1.3 for persons with  i) active leukemia or active lymphoma;  ii) a history of active or past Ebola infection; or  iii) a history of melanoma with known metastatic disease (unless irradiated ocular tissue). c) an exclusion regarding scleral tissue has been added in Clause 13.1.6 for persons with  i) a history of melanoma with or without metastasis; or  ii) a history of solid, cancerous, non melanoma tumor with metastasis; d) a general exclusion has been added regarding persons with an intrinsic eye disease that would preclude good success of the transplant or have a risk of transmitting disease, to address other emerging pathogens/diseases; and  e) the time-frame for the collection of donor blood for laboratory testing (Clause 14.2.1.3) has been updated.  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 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 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) donor suitability assessment;  b) retrieval;  c) processing;  d) preservation;  e) packaging;  f) labelling;  g) storage;  h) quarantine;  i) evaluation;  j) record keeping;  k) error, accident, and adverse reaction investigation and reporting; and  l) distribution, importation or exportation, and recall.  1.3 This Standard is not intended to replace detailed specifications and standard operating procedures but is intended to be used in their preparation.  1.4 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 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.