What does sch1-8.3-8.5 require?

A device meant to be supplied sterile must be designed, produced and packed so that it is sterile when supplied and stays so, if stored and transported as directed, until its protective packaging is opened or damaged; it must be made and sterilised by an appropriate validated method and in suitably controlled conditions. A device supplied non-sterile must be packed to keep the cleanliness level the manufacturer specifies; if it is to be sterilised before use, the packaging must keep microbial contamination low and suit the sterilisation method the manufacturer names, and it too must be made in controlled conditions. Where a device is supplied both ways, the information must make the state plain.

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
sch1-12.5-12.11 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

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