Preface
This is the third edition of CAN/CSA-Z900.2.2, 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.
The major changes to this edition include the following:
a) the terminology has been updated;
b) Clause 14 has been revised to align with CBS Evidence-based leading practice guidelines for: Tissue recovery, microbial sampling, processing of musculoskeletal tissue, processing of cardiac tissue, and processing of skin tissue;
c) exclusion criteria have been added for persons with a history or active or past Ebola infection in Clause 13.1.2; and
d) process and recovery times have been updated in Table 1.
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 tissues used for transplantation. It includes quality system requirements and aspects of safety for potential and actual donors and recipients, personnel, and others who could be exposed to, or affected by, the transplant of tissues.
1.2
This Standard applies to establishments and individuals involved in the following activities related to tissues intended for transplantation:
a) processing;
b) evaluation of the safety of tissues prior to transplantation;
c) recordkeeping;
d) error, accident, and adverse reaction investigation;
e) distribution;
f) importation or exportation; and
g) complaints and recalls.
Notes:
1) Examples of establishments or individuals include the following:
a) tissue banks;
b) tissue processing facilities;
c) transplant programs and facilities (hospital and clinic);
d) tissue retrieval organizations; and
e) other tissue-dispensing services.
2) For guidance on autologous tissues, see AORN Guideline for Autologous Tissue Management in Guidelines for Perioperative Practice.
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 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
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