Document ID: chunk:federal_register_of_legislation:F2024C00866:clause:1_1:p1
Version: federal_register_of_legislation:F2024C00866
Segment Type: clause
Provision Reference: sch 1 cl 1 (pt 1/8)
Character Range: 9799–13452

1                        all of the following matters:
                           (a) ISO 13485 certification for the manufacture of the therapeutic vaping device or the therapeutic vaping device accessory, issued by one of the following:
                              (i) an IAF accredited organisation;
                              (ii) a notified body;
                              (iii) an auditing organisation recognised by Health Canada;
                              (iv) an Australian conformity assessment body determined under the MD Regulations;
                           (b) compliance to ISO 13485 for the manufacture of the therapeutic vaping device or the therapeutic vaping device accessory
   2                     all of the following matters:
                           (a) ISO 14971 compliance for the application of risk management to the therapeutic vaping device or the therapeutic vaping device accessory, including but not limited to the management of:
                              (i) hazards or risks relating to the toxicity of emissions from the therapeutic vaping device or the therapeutic vaping device accessory, for the expected lifetime of the device, as identified in a toxicological risk assessment; and
                              (ii) hazards or risks relating to the toxicity of the materials within the therapeutic vaping device or therapeutic vaping device accessory, and any residues or contaminants, for the expected lifetime of the device; and
                              (iii) hazards or risks relating to batteries (if applicable), including risk of fire or explosion; and
                              (iv) electrical hazards or risks; and
                              (v) hazards or risks relating to the usability of the therapeutic vaping device or the therapeutic vaping device accessory; and
                              (vi) hazards or risks relating to the reasonably foreseeable misuse of the therapeutic vaping device or the therapeutic vaping device accessory; and
                              (vii) hazards or risks relating to the containment of a therapeutic vaping substance in, and the administration of a therapeutic vaping substance by, the therapeutic vaping device or the therapeutic vaping device accessory; and
                              (viii) hazards or risks relating to heating of the therapeutic vaping device or therapeutic vaping device accessory;
                           (b) the manufacturer must establish and maintain a risk management file, which documents the risk assessment process for managing all hazards or risks associated with a therapeutic vaping device or a therapeutic vaping device accessory, including the hazards or risks mentioned in paragraph (a)
   3                     all of the following matters, as applicable to the therapeutic vaping device or the therapeutic vaping device accessory:
                           (a) for a primary battery (other than a button battery)—IEC 60086-1 certification (as applicable) issued by an accredited certification body;
                           (b) for a secondary battery (other than a button battery) that is a lithium battery—both of the following:
                              (i) UN/DOT 38.3 certification, or declaration of conformity with UN/DOT 38.3, supported by independent test reports from an ISO 17025 accredited laboratory;
                              (ii) IEC 62133-2 certification issued by an accredited certification body;
                           (c) for a secondary battery (other than a button battery) that is a nickel system battery—IEC 62133-1 certification issued by