a well-reasoned and documented risk analysis evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis From the Therapeutic Goods (Medical Devices) Regulations 2002—Schedule 1, Part 2 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. 12.11 Protection against risks associated with heat The work undertaken by the manufacturer could involve, but is not restricted to: a well-reasoned and documented risk analysis evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis From the Therapeutic (Medical Devices) Regulations 2002—Schedule 1, Part 2 Protection against risks associated with administration of energy or substances This clause applies in relation to a medical device that is intended by the manufacturer to be used to administer energy or a substance to a patient. The device must be designed and produced in a way that ensures that: the delivered rate and amount of energy, or of the substance, can be set and maintained accurately to ensure the safety of the patient and the user; and as far as possible, the accidental release of dangerous levels of energy or of the substance is prevented. The device must be fitted with a of indicating or, if appropriate, preventing inadequacies in the rate and amount of energy, or of the substance, administered that might cause danger to the patient, the user or any other person. The functions of each control and indicator on the device must be clearly specified on the device. If the instructions for the operation of the device, or the operating or adjustment parameters for the device, are displayed by means of a visual system incorporated into the device, the instructions or parameters must be able to be understood by the user and, if appropriate, the patient. 12.12 Protection against associated with administration of energy or substances The work undertaken by the manufacturer could involve, but is not restricted to: a well-reasoned and documented risk analysis ensuring that operational information displayed by the device is clearly understandable evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis
a well-reasoned and documented risk analysis evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis From the Therapeutic Goods (Medical Devices) Regulations 2002—Schedule 1, Part 2 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. 12.11 Protection against risks associated with heat The work undertaken by the manufacturer could involve, but is not restricted to: a well-reasoned and documented risk analysis evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis From the Therapeutic (Medical Devices) Regulations 2002—Schedule 1, Part 2 Protection against risks associated with administration of energy or substances This clause applies in relation to a medical device that is intended by the manufacturer to be used to administer energy or a substance to a patient. The device must be designed and produced in a way that ensures that: the delivered rate and amount of energy, or of the substance, can be set and maintained accurately to ensure the safety of the patient and the user; and as far as possible, the accidental release of dangerous levels of energy or of the substance is prevented. The device must be fitted with a of indicating or, if appropriate, preventing inadequacies in the rate and amount of energy, or of the substance, administered that might cause danger to the patient, the user or any other person. The functions of each control and indicator on the device must be clearly specified on the device. If the instructions for the operation of the device, or the operating or adjustment parameters for the device, are displayed by means of a visual system incorporated into the device, the instructions or parameters must be able to be understood by the user and, if appropriate, the patient. 12.12 Protection against associated with administration of energy or substances The work undertaken by the manufacturer could involve, but is not restricted to: a well-reasoned and documented risk analysis ensuring that operational information displayed by the device is clearly understandable evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis
devices-argmd-p1-01.docx