Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_12:p3
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 12 (pt 3/4)
Character Range: 286476–289274

Minimisation of risk of electromagnetic fields
  A medical device must be designed and produced in a way that ensures that the risk of an electromagnetic field being created that could impair the operation of other devices or equipment being used in the vicinity of the medical device is minimised.

12.6  Protection against electrical risks
  A medical device must be designed and produced in a way that ensures that, as far as possible, when the device is installed correctly, and the device is being used for an intended purpose under normal conditions of use and in the event of a single fault condition, patients, users, and any other persons, are protected against the risk of accidental electric shock.

12.7  Protection against mechanical risks
  A medical device must be designed and produced in a way that ensures that a patient, the user, and any other person, is protected against any mechanical risks associated with the use of the device.

12.8  Protection against risks associated with vibration
 (1) A medical device must be designed and produced in a way that ensures that any risks associated with vibrations generated by the device are minimised.
 (2) If vibrations are not part of the intended performance of the device, particular attention must be given to relevant technical progress, and the available means, for limiting vibrations, particularly at source.

12.9  Protection against risks associated with noise
 (1) A medical device must be designed and produced in a way that ensures that any risks associated with noise emitted by the device are minimised.
 (2) If noise is not part of the intended performance of the device, particular attention must be given to relevant technical progress, and the available means, for reducing the emission of noise, particularly at source.

12.10  Protection against risks associated with terminals and connectors
  A medical device that is intended by the manufacturer to be connected to an electric, gas, hydraulic, pneumatic or other energy supply must be designed and produced in a way that ensures that any risks to the user associated with the handling of a terminal or connector on the device, in relation to the energy supply, are minimised.

12.11  Protection against risks associated with heat
  A medical device must be designed and produced in a way that ensures that, during normal use, any accessible part of the device (other than any part intended by the manufacturer to supply heat or reach a given temperature), and any area surrounding an accessible part of the device, does not reach a potentially dangerous temperature.

12.12  Protection against risks associated with administration of energy or substances
 (1) This clause applies in relation to a medical device that is intended by the manufacturer to be used