Draft Details

1.1 Purpose

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 Inclusions

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 Limitations

This Standard is not intended to replace detailed specifications and SOPs but is intended to be used in their preparation.

1.4 Priority

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 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.