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Safety of Human Cells, Tissues and Organs for Transplantation Regulations (SOR/2007-118)

Regulations are current to 2024-02-06 and last amended on 2023-11-24. Previous Versions

Processing (continued)

Packaging and Labelling (continued)

Labelling (continued)

Marginal note:Tissues

 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 1Column 2Column 3
From retrieval establishment to tissue bankFrom tissue bank to any other establishment
ItemRequired informationInterior labelPackage insertExterior labelInterior labelPackage insertExterior label
Information about donor and tissue
1Name of tissue, and whether left or right side, if applicableXXXX
2Description of tissueXX
3Donor identification code, clearly labelled as suchXX
4Information capable of identifying the donorXX
5Donor assessment recordX
6The pictogram entitled “Biohazardous infectious materials” set out in Schedule 3 to the Hazardous Products Regulations, if applicableXXXX
Retrieval information
7Date, time and time zone of asystole or aortic clamping, if applicableX
8Date, time and time zone of retrievalX
9Information specific to retrieval procedureX
Processing information
10Name of storage solution, if applicableXX
11Name of anticoagulant and other additive, if applicableX
12Statement that the tissue has been irradiated, if applicableXX
13Description of the disinfection and sterilization processes that were used, if applicableX
14Statement “For Autologous Use Only”, if applicableXXXX
Information for transplant establishment
15Tissue-specific instructions for preparation for use, if applicableX
16Statement that the tissue has been declared safe for transplantationX
17Statement “For Exceptional Distribution”, if applicableXX
18If applicable, the reasons for exceptional distribution and a statement of how the tissue does not meet the requirements of these RegulationsX
19Instructions on how to report errors, accidents and adverse reactionsX
20Expiry date and time, if applicableXX
Establishment information
21Name of retrieval establishment, its civic address and contact informationXX
22Name of source establishment, its civic address and contact informationXXXX
23Registration number of source establishment, clearly labelled as suchXX
24Name of transplant establishment, if known, its civic address and contact informationX
Storage information
25Statement “Human tissue for transplant”XX
26Handling instructions for storage and for storage during transportationXX
  • SOR/2015-17, s. 18
 

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