Australia Therapeutic Goods (Medical Devices) Regulations 2002 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

What does sch1-13.4 require?

Instructions for use must accompany each device, although a Class I, Class IIa or Class 1 IVD device that can be used safely for its purpose without them may omit or shorten them. The instructions must cover whichever of the table items apply, including: manufacturer details; intended purpose, user and patient; risks from other equipment nearby (such as electrosurgical or MRI interference); intended performance and side effects; contraindications, warnings and precautions; identification; storage and handling; single-use or custom-made status; sterile state, what to do if the sterile pack is damaged and resterilisation; cleaning and sterilisation before use; installation checks and calibration; maintenance and replacement of consumables; preparation before use; compatible equipment for safe combinations; implantation risks; reprocessing and the number of safe reuses; radiation emitted; precautions if performance changes or under adverse environments; medicines the device administers or incorporates; animal tissue content where Schedule 2 clause 5.5 applies; disposal risks; claimed accuracy; required facilities and user training; the IVD test principle, specimen, reagent, assay, interference, analytical and clinical performance and reference intervals; and assembly instructions for adaptable devices and process instructions for production systems.