Profile Page for Guidance Document for Cell, Tissue and Organ Establishments - Safety of Human Cells, Tissues and Organs for Transplantation

[Health Canada]

Overview

The Safety of Human Cells, Tissues and Organs for Transplantation Regulations apply to all individuals and establishments that handle, process, distribute or import human organs, or minimally manipulated cells and tissues for homologous use, for transplantation in another individual in Canada. This guidance document provides an interpretation of the Regulations.

In this guide

• Introduction
• Policy Objectives
• Scope and Application
• Background
• CSA Group National Standard
• Acronyms
• Guidance for Implementation
  • Interpretation (Section 1 of the CTO Regulations)
  • Application (Sections 2 & 3 of the CTO Regulations)
  • Prohibition (Section 4 of the CTO Regulations)
  • Registration (Sections 5 to 14 of the CTO Regulations)
  • Source Establishment (Section 15 of the CTO Regulations)
  • Processing (Sections 16 to 27 of the CTO Regulations)
  • Packaging and Labelling (Sections 28 to 33 of the CTO Regulations)
  • Quarantine (Section 34 of the CTO Regulations)
  • Storage (Sections 35 to 39 of the CTO Regulations)
  • Exceptional Distribution (Sections 40 to 42 of the CTO Regulations)
  • Errors, Accidents and Adverse Reaction Investigation and Reporting (Sections 43 to 54 of the CTO Regulations)
  • Records (Sections 55 to 63 of the CTO Regulations)
  • Personnel, Facilities, Equipment and Supplies (Sections 64 to 69 of the CTO Regulations
  • Quality Assurance System (Sections 70 to 76 of the CTO Regulations)
  • Powers of Inspectors (Section 77 of the CTO Regulations)
  • Transitional Provisions (Section 78 of the CTO Regulations)
  • Coming into Force (Section 79 of the CTO Regulations)
• Appendices
  • Appendix 1: Decision Tree for Help in the Classification of CTO
  • Appendix 2: Appropriate and effective tests for infectious disease testing
  • Appendix 3: Revised Measures to Address the Potential Risk of Zika Virus Transmission through Human Cells, Tissues and Organs

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Details and history

Published: June 18, 2013

Updated: May 31, 2018

Consulted: January 26, 2018

Part of topic(s): Guidance on legislation