Document ID: chunk:federal_register_of_legislation:F2024C00866:reg:4:p1
Version: federal_register_of_legislation:F2024C00866
Segment Type: reg
Provision Reference: reg 4 (pt 1/2)
Character Range: 2558–5690

4  Definitions
Note 1: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) essential principles;
(b) medical device standard;
(c) therapeutic goods.
  In this instrument:
accredited certification body means a body that is accredited to undertake certification for compliance with IEC 60086-1, IEC 62133-1 or IEC 62133-2, by an International Electrotechnical Commission accepted national certification body.
Act means the Therapeutic Goods Act 1989.
AS/NZS 3820 means Australian/New Zealand Standard AS/NZS 3820, Essential safety requirements for electronic equipment, published jointly by, or on behalf of, Standards Australia and Standards New Zealand, as in force or existing from time to time.
Note: AS/NZS 3820 is published at www.standards.org.au.
AS/NZS 4417.1 means Australian/New Zealand Standard AS/NZS 4417.1, Marking of electronic products to indicate compliance with regulations, published by, or on behalf of, Standards Australia and Standards New Zealand, as in force or existing from time to time.
Note: AS/NZS 4417.1 is published at www.standards.org.au.
IAF accredited organisation means an organisation that is accredited to undertake certification for compliance with ISO 13485 (or both) by an accreditation body member that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum, Inc., otherwise known as the IAF MLA.
IEC 60086-1 means IEC 60086-1, Primary Batteries – Part 1: General, published by the International Electrotechnical Commission, as in force or existing from time to time.
Note: IEC 60086 is published at www.webstore.iec.ch.
IEC 62133-1 means IEC 62133-1, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 1: Nickel systems, published by the International Electrotechnical Commission, as in force or existing from time to time.
Note: IEC 62133-1 is published at www.webstore.iec.ch.
IEC 62133-2 means IEC 62133-2, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 2: Lithium systems, published by the International Electrotechnical Commission, as in force or existing from time to time.
Note: IEC 62133-2 is published at www.webstore.iec.ch.
instructions for use has the same meaning as in the MD Regulations.
ISO 13485 means International Standard ISO 13485, Medical devices—Quality management systems—Requirements for regulatory purposes, issued by the International Organization for Standardization, as in force or existing from time to time.
Note: ISO 13485 is published at 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