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 sch1-4: Essential principle 4: within its stated safe-use life, under normal stresses and with maintenance and calibration done as instructed, the device must keep the safety and performance required by principles 1 to 3

What does sch1-4 require?

The device must be designed and made so that, as long as it is used within the period the manufacturer says it can be safely used, is not exposed to stresses beyond those of normal use, and is maintained and calibrated as the manufacturer instructs, the characteristics and performance demanded by clauses 1 to 3 do not deteriorate. This calls for a defined service life or shelf life backed by ageing, durability and reliability data.

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

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 endpointAll Australia Therapeutic Goods (Medical Devices) Regulations 2002 controls