What does sch1-12.12-12.13 require?

A device meant to administer energy or a substance must let the delivered rate and amount be set and maintained accurately for patient and user safety, prevent as far as possible accidental release of dangerous levels, have a means of indicating or, where appropriate, preventing inadequate delivery that could cause danger, show clearly the function of each control and indicator, and present any on-screen instructions or parameters so users (and patients where relevant) can understand them. Every active implant must carry some code or distinctive feature (shown, transmitted or built in) that can be read without operating on the patient and that reveals what type of device it is, who made it and the year it was made.

Australia Therapeutic Goods (Medical Devices)...

Other controls in Schedule 1 Part 2: other essential principles (clauses 7 to 15) – Australia Therapeutic Goods (Medical Devices) Regulations 2002

sch1-10 Essential principle 10: a device with a measuring function must measure accurately, precisely and stably within stated limits, use ergonomic scales and express results in Australian legal units or Secretary-approved units
sch1-11 Essential principle 11: minimise patient, user and bystander exposure to intended and stray radiation, give users control and warnings for hazardous emissions, document radiation in the operating instructions, and control ionising radiation dose and image quality
sch1-12.1-a Essential principle 12.1(1) to (4): programmed devices and software as a medical device must be safe, reliable, accurate, usable, secure and repeatable for their purpose, fail safely, warn on lost services or degraded performance, protect data integrity and privacy, follow state-of-the-art development, suit their computing platforms and state their operating requirements
sch1-12.1-b Essential principle 12.1(5) and (6): build and maintain cybersecurity by best practice (protection against unauthorised access, vulnerability management, patching, disclosure and update information) and keep performance-influencing data representative, of sufficient quality, intact and managed to reduce bias
sch1-12.2-12.4 Essential principles 12.2 to 12.4: where patient safety depends on power, provide a means to check an internal supply and an alarm for external power failure, and fit clinical-parameter monitors with alarms for dangerous patient states
sch1-12.5-12.11 Essential principles 12.5 to 12.11: minimise electromagnetic interference with nearby equipment and protect people against electric shock, mechanical, vibration, noise, connector and surface-heat hazards
sch1-13.1-13.3 Essential principles 13.1 to 13.3: provide in English, legibly and in the right place (device, packaging or leaflet), the information that identifies the device and manufacturer and explains safe use, including the clause 13.3 table items
sch1-13.4 Essential principle 13.4: supply instructions for use carrying every applicable clause 13.4 table item, unless a Class I, IIa or Class 1 IVD device can be used safely without them

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All Australia Therapeutic Goods (Medical Devices) Regulations 2002 controls