CAN CSA Z900.1:2017 pdf download.Cells, tissues, and organs for transpl lantation: General requirements
1.4 CAN CSA Z900.1 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 This Standard applies to human cells, tissues, and organs retrieved from a living or deceased human body and intended for transplantation into humans. The requirements for cells and tssues 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) tissues such as heart valves and dura mater, which are classified by Health Canada as a medical device and are subject to the requirements of the Medical Devices Regulations. Users seeking to market heart valves will require a medical device license; and
b) autologous tissue banking.
4.1.5 The affiliations, governing board, and policy making authority of the establishment shall be clearly described and documented. Documentation should include the names and addresses of all affiliations of the establishment, the agreements and contracts defining activities to be performed, and the personnel responsible for compliance with this Standard and for performing audits or using other means to verify that these entities are in compliance with this Standard.
4.2.1.1 Qualified and experienced personnel, as defined in the standard operating procedures (SOPs), shall be available to carry out required procedures. They shall have the skills, experience, educational background, training, and necessary authority to perform their duties properly and safely, and to ensure that quality assurance (QA) activities are carried out.
4.2.2.4 The competency of personnel in the performance of their assigned duties shall be assessed following training and documented at regular and routine intervals thereafter, as established by the SOPs.Assessment of the competency of personnel regarding the procedures they perform and the corrective actions to be implemented for poor performance shall be documented in the SOPs.
A competency assessment program should evaluate the theoretical and practical knowledge of the procedures, and should include, but not be limited to,
a) direct observation of performance;
b) monitoring of recording and reporting;
c) written tests to assess problem-solving skills; and
d) assessment of knowledge of operating procedures and theory.CAN CSA Z900.1 pdf download.