Document ID: chunk:federal_register_of_legislation:F2024C00866:reg:4:p2
Version: federal_register_of_legislation:F2024C00866
Segment Type: reg
Provision Reference: reg 4 (pt 2/2)
Character Range: 5414–7612

www.iso.org.
ISO 14971 means International Standard ISO 14971, Medical devices – Application of risk management principles to medical devices, issued by the International Organization for Standardization, as in force or existing from time to time.
Note: ISO 14971 is published at www.iso.org.
ISO 17025 means International Standard ISO 17025, Testing and calibration laboratories, issued by the International Organization for Standardization, as in force or existing from time to time.
Note: ISO 17025 is published at www.iso.org.
ISO 17025 accredited laboratory means a laboratory that is accredited, by a member body of the International Laboratory Accreditation Cooperation, to operate in accordance with ISO 17025 to undertake certification for compliance with UN/DOT 38.3.
notified body means a body that:
 (a) has been designated by a member state of the European Union, and notified to the European Commission; or
 (b) has been approved or designated by the United Kingdom Medicines & Healthcare products Regulatory Agency;
to assess the conformity of medical devices.
MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
TG Regulations means the Therapeutic Goods Regulations 1990.
text size means the height of the following:
 (a) capital letters or lower case letters, including an ascender or descender;
 (b) numbers or numerals;
 (c) symbols.
therapeutic vaping device has the same meaning as in the MD Regulations.
therapeutic vaping device accessory has the same meaning as in the MD Regulations.
therapeutic vaping substance has the same meaning as in the TG Regulations.
UN/DOT 38.3 means section 38.3 of the United Nations document Recommendations on the Transport of Dangerous Goods: Manual of Tests and Criteria, established by the United Nations, as in force or existing from time to time.
Note: UN/DOT 38.3 applies to lithium cells and batteries, and contains criteria, test methods and procedures for the safe transportation of dangerous goods. UN/DOT 38.3 is published at www.unece.org.
venting means the emission of the battery or cell electrolyte as a liquid, droplets or vapour from a designed vent or through a seal intended to preclude rupture.