Australia Therapeutic Goods (Medical Devices) Regulations 2002
Schedule 1 Part 1: general essential principles (clauses 1 to 6) – Australia Therapeutic Goods (Medical Devices) Regulations 2002

Australia Therapeutic Goods (Medical Devices) Regulations 2002 sch1-2: Essential principle 2: choose design and construction solutions that follow safety principles and the state of the art, in the order identify hazards, design them out, protect against what remains, then tell users of residual risk

What does sch1-2 require?

The manufacturer's design and construction choices must accord with safety principles in light of the generally acknowledged state of the art. In selecting solutions it must work through a fixed order: first identify hazards and their risks from intended use and foreseeable misuse; second remove or reduce those risks as far as possible through inherently safe design; third, where suitable, add protective measures, alarms included, for risks that cannot be removed; and last, inform users of residual risk left because the protective measures fall short. Residual risk is what is left after the first three steps.

Maintained by Gerard Blokdyk

Other controls in Schedule 1 Part 1: general essential principles (clauses 1 to 6) – Australia Therapeutic Goods (Medical Devices) Regulations 2002

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