Document ID: chunk:federal_register_of_legislation:F2024C00866:clause:1_1:p2
Version: federal_register_of_legislation:F2024C00866
Segment Type: clause
Provision Reference: sch 1 cl 1 (pt 2/8)
Character Range: 13126–16837

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 an accredited certification body;
                           (d) for a button battery—compliance with all of the following:
                              (i) the Consumer Goods (Button/Coin Batteries) Information Standard 2020;
                              (ii) the Consumer Goods (Button/Coin Batteries) Safety Standard 2020;
                              (iii) the Consumer Goods (Products Containing Button/Coin Batteries) Safety Standard 2020;
                              (iv) the Consumer Goods (Products Containing Button/Coin Batteries) Information Standard 2020
                                Note: These legislative instruments are published on the Federal Register of Legislation at www.legislation.gov.au
   4                     all of the following matters, as applicable to the therapeutic vaping device or the therapeutic vaping device accessory:
                           (a) AS/NZS 3820 compliance with essential safety requirements for low voltage electrical equipment;
                           (b) AS/NZS 4417.1 compliance with marking of electrical products to indicate compliance with regulations
   5                     a therapeutic vaping device, and a therapeutic vaping device accessory as applicable, must be designed and constructed in a way that:
                           (a) when operated in accordance with the instructions for use, the device provides the emitted mass or dose as specified and verified by the manufacturer; and
                           (b) incorporates a reliable venting mechanism that channels the pressure wave in the direction where the harm is minimised; and
                           (c) minimises the risk of inadvertent actuation; and
                           (d) ensures that any external parts or accessible surfaces, other than the mouthpiece, of the device that may be held or grasped during use does not exceed 48°C during use; and
                           (e) ensures that the external surface of the mouthpiece does not exceed 55°C during use; and
                           (f) ensures that the device will withstand regular use, and foreseeable misuse or abuse, without breaking, leaking or failing in an unsafe manner; and
                           (g) incorporates child-resistant features to prevent:
                              (i) the operation of the device by children; and
                              (ii) the accidental ingestion of components of, or substances contained in, the device; and
                           (h) for a therapeutic vaping device or a therapeutic vaping device accessory that is, or contains, a battery—accords with relevant electrical safety standards to protect against overheating, short-circuiting, and the risk of explosion during use and recharging; and
                           (i) prevents leaks of the therapeutic vaping substance being vaporised; and
                           (j) ensures that all materials used in the inhalation pathway of the device, including any by-products or degradants, are biocompatible and the amount of harmful chemicals (such as heavy metals, volatile organic compounds, and other toxic substances) that the patient receives is less than the tolerable exposure limit below which there would be no appreciable risk to human health
   6                     the name (including brand name) of a therapeutic vaping device or