Safety of Human Cells, Tissues and Organs for Transplantation Regulations (SOR/2007-118)
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Regulations are current to 2024-10-30 and last amended on 2023-11-24. Previous Versions
Processing (continued)
Packaging and Labelling (continued)
Labelling (continued)
Marginal note:Tissues
31 An establishment that distributes tissues must ensure that all of the applicable information, as indicated by an “X”, set out in the table to this section is provided on the interior label, in the package insert and on the exterior label.
TABLE TO SECTION 31
Labelling Requirements for Tissue
| Column 1 | Column 2 | Column 3 | |||||
|---|---|---|---|---|---|---|---|
| From retrieval establishment to tissue bank | From tissue bank to any other establishment | ||||||
| Item | Required information | Interior label | Package insert | Exterior label | Interior label | Package insert | Exterior label |
| Information about donor and tissue | |||||||
| 1 | Name of tissue, and whether left or right side, if applicable | X | X | X | X | ||
| 2 | Description of tissue | X | X | ||||
| 3 | Donor identification code, clearly labelled as such | X | X | ||||
| 4 | Information capable of identifying the donor | X | X | ||||
| 5 | Donor assessment record | X | |||||
| 6 | The pictogram entitled “Biohazardous infectious materials” set out in Schedule 3 to the Hazardous Products Regulations, if applicable | X | X | X | X | ||
| Retrieval information | |||||||
| 7 | Date, time and time zone of asystole or aortic clamping, if applicable | X | |||||
| 8 | Date, time and time zone of retrieval | X | |||||
| 9 | Information specific to retrieval procedure | X | |||||
| Processing information | |||||||
| 10 | Name of storage solution, if applicable | X | X | ||||
| 11 | Name of anticoagulant and other additive, if applicable | X | |||||
| 12 | Statement that the tissue has been irradiated, if applicable | X | X | ||||
| 13 | Description of the disinfection and sterilization processes that were used, if applicable | X | |||||
| 14 | Statement “For Autologous Use Only”, if applicable | X | X | X | X | ||
| Information for transplant establishment | |||||||
| 15 | Tissue-specific instructions for preparation for use, if applicable | X | |||||
| 16 | Statement that the tissue has been declared safe for transplantation | X | |||||
| 17 | Statement “For Exceptional Distribution”, if applicable | X | X | ||||
| 18 | If applicable, the reasons for exceptional distribution and a statement of how the tissue does not meet the requirements of these Regulations | X | |||||
| 19 | Instructions on how to report errors, accidents and adverse reactions | X | |||||
| 20 | Expiry date and time, if applicable | X | X | ||||
| Establishment information | |||||||
| 21 | Name of retrieval establishment, its civic address and contact information | X | X | ||||
| 22 | Name of source establishment, its civic address and contact information | X | X | X | X | ||
| 23 | Registration number of source establishment, clearly labelled as such | X | X | ||||
| 24 | Name of transplant establishment, if known, its civic address and contact information | X | |||||
| Storage information | |||||||
| 25 | Statement “Human tissue for transplant” | X | X | ||||
| 26 | Handling instructions for storage and for storage during transportation | X | X | ||||
- SOR/2015-17, s. 18
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