Information & Training. | Medical Devices.

Medical Devices – With a Measuring Function

Principles 10 & 11 – Radiation

Medical Devices with a Measuring Function:

A medical device that has a measuring function must be designed and produced in a way that ensures that the device provides accurate, precise and stable measurements within the limits indicated by the manufacturer and having regard to the intended purpose of the device.

The measurement, monitoring and display scale of the device must be designed and produced in accordance with ergonomic principles, having regard to the intended purpose of the device.

The measurements made by the device must be expressed:

in Australian legal units of measurement; or if the device measures a physical quantity for which no Australian legal unit of measurement has been prescribed under the National Measurement Act 1960, in units approved by the Secretary for the particular device.

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How to demonstrate compliance:

Essential Principle 10 only applies to medical devices with a measuring function (as defined in Regulation 1.4). Other kinds of measurement are not covered by Essential Principle 10.

The device must perform a measuring function that provides an absolute quantitative measurement (legal units or reference to a fixed reference) of a physiological/anatomical parameter (or energy/substance delivered/removed from the body) in which the accuracy is critical for the intended purpose of the device.

Manufacturers are expected to consider product specific standards, pharmacopeial monographs, and applicable guidance documents in order to ensure the device is designed and produced in an appropriate way. For example, the manufacturer of a measuring cup or spoon might refer to the relevant pharmacopeial monograph in order to determine the specification and accuracy of the device. Manufacturers may also refer to production process controls that ensure the measuring function is accurate and reliable. This will usually involve calibration against an appropriate reference standard.

Ergonomic principles concerned with how a user of the device interprets the outputs from the device and uses the device must be incorporated in the design and production processes for the device. The usability standards: IEC 62366: Medical devices—Application of usability engineering to medical devices, and IEC 60601-1-6: Medical electrical equipment—Part 1-6: General requirements for basic safety and essential performance—Collateral standard: Usability is directly relevant to Essential Principle 10(2).

The measurement outputs must be in Australian legal or otherwise approved units.

Principle 11—Protection against radiation:

11.1 Minimisation of exposure to radiation

A medical device must be designed and produced in a way that ensures that the exposure of a patient, the user, or any other person, to radiation is minimised, having regard to the levels of radiation required to enable the device to perform its therapeutic and diagnostic functions and the intended purpose of the device.

11.1 Minimisation of exposure to radiation:

This Essential Principle is intended to cover all forms of radiation.

Australian and international standards related to radiation exposure limits and other applicable legislation (for example, Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) and Australian Communications and Media Authority (ACMA) requirements and state/territory radiation protection legislation) are also relevant to Essential Principle 11.

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

– Evidence of appropriate radiation shielding

– Where can I find more information?

– ARPANSA: <http://www.arpansa.gov.au>

– ACMA: <http://www.acma.gov.au>

– Additional information is also provided in Section 13. Active medical devices.

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11.2 Medical devices intended to emit radiation:

This clause applies in relation to a medical device that is intended by the manufacturer to emit hazardous levels of visible or invisible radiation because the emission is necessary for a specific medical purpose, the benefit of which is considered to outweigh the risks inherent in the emission.
The device must be designed and produced in a way that ensures that the user can control the level of the emission.
The device must be designed and produced in a way that ensures the reproducibility and tolerance of relevant variable parameters.
If practicable, the device must be fitted with a visual indicator or an audible warning, or both, that operates if potentially hazardous levels of radiation are emitted.

The work undertaken by the manufacturer could involve, but is not restricted to:

A well-reasoned and documented risk analysis demonstrating that appropriate control and indicator mechanisms have been incorporated into the device to ensure the operational consistency of variable parameters relevant to the emission of the radiation and the operation of the device. Evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis.

Minimisation of exposure to unintended radiation:

A medical device must be designed and produced in a way that ensures that the exposure of a patient, the user, or any other person, to the emission of unintended, stray or scattered radiation is minimised.

11.3 Minimisation of exposure to unintended radiation:

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.

Operating instructions:

The operating instructions for a medical device that emits radiation must include detailed information about the following matters:

The nature of the radiation emitted.

The means by which patients and users can be protected from the radiation.

Ways to avoid misusing the device.

Ways to eliminate any risks inherent in the installation of the device.

11.4 Operating instructions:

The work undertaken by the manufacturer could involve, but is not restricted to:

A well-reasoned and documented risk analysis.

The Instructions for Use for the device must include particular information about the emitted radiation, appropriate protection measures, foreseeable misuse of the device and eliminating foreseeable risks arising from the installation of the device.

11.4 Medical devices intended to emit ionising radiation—additional requirements:

This clause applies, in addition to clauses 11.1 to 11.4, in relation to a medical device that is intended by the manufacturer to emit ionising radiation.

The device must be designed and produced in a way that ensures that, if practicable, the quantity, geometry and energy distribution (or quality) of radiation emitted can be controlled and varied, having regard to the intended purpose of the device.

If the device is intended to be used for diagnostic radiology, the device must be designed and produced in a way that ensures that, when used in relation to a patient for a purpose intended by the manufacturer:

– the device achieves an appropriate image or output quality for that purpose; and

– the exposure of the patient, or the user, to radiation is minimised.

If the device is intended to be used for therapeutic radiology, the device must be designed and produced in a way that ensures that the delivered dose of radiation, the type and energy of the radiation beam and, if appropriate, the energy distribution of the radiation beam, can be reliably controlled and monitored.

11.5 Medical devices intended to emit ionising radiation—additional requirements:

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Reference: Medical Device Regulation (TGA). Meeting the Essential Principles—Principles about Design and Construction