CAN/CSA-Z900.1:22

1 Scope 1.1 Purpose This Standard specifies general requirements related to the safety of human CTOs used for transplantation, and includes quality system requirements. It includes aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to or affected by the transplantation of CTOs. 1.2 Areas of application This Standard applies to establishments and individuals involved in the following activities related to CTOs intended for transplantation: a) processing; b) evaluation of the safety of CTOs prior to transplantation; c) transplantation procedures; d) recordkeeping; e) error, accident, and adverse reaction reporting; f) distribution; g) importation or exportation; and h) complaints and recalls. 1.3 Inclusions 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 h) in Clause 1.2. Note: Examples of establishments or individuals include the following: a) organ donation organizations; b) tissue retrieval organizations; c) tissue banks; d) eye banks; e) cell or tissue processing facilities (e.g., including islet cells); f) cell culture laboratories; g) histocompatibility laboratories; h) transplant programs and facilities (e.g., hospitals and special clinics); i) programs for lymphohematopoietic cells, including clinical programs, collection and processing facilities; j) health care professionals; k) designated importers and exporters; l) distributors; and m) other cell-, tissue-, and organ-dispensing services. 1.4 Limitations of use This Standard and its subset Standards (i.e., the CAN/CSA-Z900 series) are not intended to replace detailed specifications and standard operating procedures, but are intended to be used in their preparation. 1.5 Intended scope This Standard applies to human CTOs retrieved from a living or deceased human body and intended for transplantation into humans. The requirements for cells and tissues in this Standard are intended for minimally manipulated cells and tissues intended for homologous use (i.e., the cells or tissues perform the same basic function after transplantation). Notes: 1) Although the scope of this Standard refers to minimally manipulated cells and tissues, some of its requirements can also be relevant to other human cellular and tissue-based products. 2) It is recognized that the topics covered by this Standard can fall within more than one regulatory jurisdiction. Two specific topics covered by this Standard that are not within the current scope of Health Canada’s Safety of Human Cells, Tissues and Organs for Transplantation Regulations are a) dura mater, which is classified as a medical device by Health Canada and is subject to the requirements of the Medical Devices Regulations; and b) autologous cell and tissue banking. 3) Heart valves are classified by Health Canada as either a medical device or CTO. 1.6 Limitations of scope This Standard does not apply to a) tissues for assisted reproduction (see CAN/CSA-Z900.2.1); b) human milk and other excreted or secreted substances; c) whole blood (except for cord blood), blood components, or blood products; and d) fecal transplantation. Notes: 1) For blood components (i.e., red blood cells, granulocytes, platelets, plasma, and cryoprecipitate) and blood products (i.e., therapeutic products derived from plasma), see CAN/CSA-Z902. 2) CAN/CSA-Z900.2.5 includes specific requirements for cord blood. 1.7 Subset standards Subset standards have been developed for CTOs (see Clause 2). Where an applicable subset standard exists, this Standard is to be used in conjunction with that subset standard. Note: Where a subset standard exists and its requirements differ from this Standard’s requirements, the subset standard’s requirements apply. 1.8 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.