What does sch1-12.5-12.11 require?

The device must be designed and made so that the risk of it creating an electromagnetic field that could impair other equipment nearby is minimised; so that, when correctly installed and used as intended, including under a single fault, people are protected as far as possible against accidental electric shock; so that patients, users and others are protected against mechanical risks; so that risks from vibration and from noise it generates are minimised, reducing them at source where they are not part of its purpose by drawing on technical progress; so that handling terminals and connectors to electric, gas, hydraulic, pneumatic or other supplies is low risk; and so that accessible parts and surrounding areas do not reach dangerous temperatures in normal use, apart from parts meant to heat.

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
sch1-12.12-12.13 Essential principles 12.12 and 12.13: devices that deliver energy or substances must set and hold the delivered rate and amount accurately, prevent accidental dangerous release, flag inadequate delivery and label controls clearly; active implants must carry a code readable without surgery identifying type, manufacturer and year
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
sch1-13.1-13.3 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

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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