HKIE Professional Assessment - Biomedical Discipline key terms

The ability of a material or device to perform its intended function in contact with living tissue without causing unacceptable local or systemic harm, assessed through ISO 10993 biological evaluation tests.

The international standard series governing biological evaluation of medical devices, specifying which tests (cytotoxicity, sensitisation, implantation and others) apply based on contact nature and duration.

The degree to which a material or its extractables damages or kills cells, typically screened in vitro with mammalian cell cultures and graded by morphological or viability scoring.

Reduction of mechanical load carried by bone when a stiffer implant shares the load, leading to bone resorption and loosening; a key reason implants use titanium or lower-modulus alloys.

The ratio of stress to strain in the linear region of a material's stress-strain curve, indicating stiffness; matching it to tissue reduces stress shielding and soft-tissue injury.

Fracture of a device after repeated cyclic loading below its ultimate strength, common in implants, catheters and instrument components subjected to millions of service cycles.

Direct structural and functional bonding between living bone and an implant surface without intervening fibrous tissue, essential for dental implants and orthopaedic prostheses.

The property of a blood-contacting material to avoid triggering thrombosis, haemolysis, complement activation or platelet consumption during its intended contact period.

The core international safety standard for medical electrical equipment, covering means of protection, risk management, essential performance and classification by shock protection and applied part type.

The part of medical electrical equipment that comes into physical contact with the patient to perform its function, classified as Type B, BF or CF by permitted leakage current.

Current flowing from an applied part through the patient to earth, limited by IEC 60601-1 according to applied part type and normal or single-fault condition.

The risk of ventricular fibrillation from very small currents (tens of microamps) applied directly to the heart via intracardiac catheters, driving strict limits for Type CF applied parts.

Performance of a clinical function by medical electrical equipment that, if lost or degraded beyond limits, creates unacceptable risk; must be defined and verified under IEC 60601-1.

An action or design feature adopted to reduce risk, applied in the preferred order of inherent safety, protective measures, then information for safety, as required by ISO 14971.

The international standard for applying risk management to medical devices, covering hazard identification, risk estimation and evaluation, risk control, and monitoring of production and post-production information.

The risk remaining after risk control measures have been applied, which must be evaluated against benefit and disclosed in accompanying information where it is judged acceptable.

A potential source of harm, such as electrical energy, a software defect, a biological contaminant or a use error, distinguished in risk management from the harm it may cause.

An act or omission by the user during interaction with a device that leads to a different result than intended, addressed through usability engineering rather than blaming the operator.

The standard for applying usability engineering to medical devices, requiring identification of use-related hazards and validation of the user interface through simulated use with representative users.

Iterative usability testing performed during design to identify interface problems and refine the device early, before the summative validation required by IEC 62366.

The international quality management system standard specific to medical device organisations, requiring documented processes for design, production, traceability, complaint handling and regulatory reporting.

Corrective and preventive action: a closed-loop quality process for investigating root causes of nonconformities and implementing changes that prevent recurrence, recorded and verified for effectiveness.

A compilation of records describing the design history of a finished device, demonstrating that the design was developed in accordance with the approved design plan and quality system.

Two distinct confirmation activities: verification checks that design outputs meet specified requirements, while validation confirms that the device meets user needs in the intended clinical use environment.

The systematic appraisal of clinical data, including literature and own investigations, to demonstrate safety and performance of a device for its intended purpose throughout its lifecycle.

The ongoing collection and analysis of real-world device performance data after release, including complaints, vigilance reports and field safety corrective actions, feeding back into risk management.

Mandatory notification to a regulator of incidents involving death, serious injury or serious public health risk associated with a device, within defined timelines after becoming aware.

Hong Kong's voluntary framework administered by the Medical Device Division, comprising listing of devices, traders and manufacturers plus post-market surveillance, pending a statutory regime.

The healthcare engineering discipline responsible for selecting, maintaining, calibrating and safely managing medical equipment, and advising clinical services on technology acquisition and use.

Scheduled inspection, testing and servicing of equipment at defined intervals to keep performance within specification and detect deterioration before it causes failure or harm.

An unbroken chain of comparisons linking a measurement made by a device to a national or international reference standard, each step having stated uncertainty.

A quantified range around a measured value within which the true value is expected to lie, combining contributions from the instrument, operator, environment and reference standard.

Verification performed when new equipment arrives on site, confirming that it meets purchase specification and safety requirements before first clinical use and entry into the asset register.

The average operating time between successive failures of a repairable device, used in reliability modelling, maintenance planning and replacement decisions.

A multidisciplinary appraisal of the clinical effectiveness, safety, cost and organisational impact of a health technology, informing adoption, procurement and disinvestment decisions.

The total cost of ownership of equipment over its useful life, including acquisition, installation, consumables, maintenance, training, downtime and disposal.

The ability of a differential amplifier to suppress a signal common to both inputs, such as mains interference, expressed as the ratio of differential gain to common-mode gain, usually in decibels.

The ratio of the power of a wanted physiological signal to the power of unwanted noise, often improved by averaging, filtering or shielding in biomedical acquisition systems.

An analogue low-pass filter placed before sampling to remove frequency content above half the sampling rate, preventing high-frequency components from folding back into the sampled signal.

The minimum sampling frequency, twice the highest frequency present in a signal, required to reconstruct the signal without aliasing.

The ability of equipment to operate in its electromagnetic environment without causing or suffering unacceptable disturbance, verified by emission and immunity tests under IEC 60601-1-2.

The standard for exchanging medical images and associated information between scanners, workstations and archives, defining file format, network services and data element encoding.

Picture archiving and communication system: the hospital infrastructure that stores, retrieves and displays medical images, interfacing with imaging modalities via DICOM and with records via HL7.

A modern healthcare interoperability standard using modular resources and web APIs to exchange clinical and administrative data between hospital systems and applications.

Irreversible removal or transformation of identifying data so that a subject can no longer be re-identified, a prerequisite for secondary use of clinical data and images in research.

The set of production and quality controls ensuring devices are consistently made to specification, covering facilities, documentation, process validation, sterilisation and release testing.

Demonstration with physical, chemical and biological indicators that a sterilisation process reliably achieves the required sterility assurance level throughout the product.

A three-dimensional temporary structure that supports cell attachment, proliferation and tissue formation, designed to degrade as new tissue replaces it.

A controlled culture system that supplies nutrients, oxygen and mechanical or electrical stimulation to growing tissue constructs, monitoring parameters to ensure reproducible quality.

A medicinal product based on genes, cells or tissues, such as somatic cell therapies and tissue-engineered products, subject to dedicated regulatory pathways and manufacturing controls.

The professional and legal obligation of an engineer to act in the safety and interests of patients and users, taking reasonable steps to prevent foreseeable harm.

Voluntary agreement by a competent person after receiving and understanding relevant information about risks, benefits and alternatives, essential in research and clinical interventions.

Reporting of unsafe, illegal or unethical practice through appropriate internal or external channels when normal routes fail, protected by professional codes and, in some jurisdictions, legislation.

A situation where personal, financial or other interests could improperly influence professional judgement, requiring declaration and management to preserve trust and objectivity.

Sustained, planned learning and reflective practice that maintains and enhances competence throughout a professional career, recorded to demonstrate fitness to practise.

An economic model that keeps materials in use through reuse, repair, refurbishment and recycling, reducing waste from single-use devices, packaging and equipment disposal.

Cleaning, disinfection or sterilisation and re-use of a device labelled single-use, permitted only with validated procedures, risk assessment and regulatory approval.

The systematic appraisal of clinical data, including literature and own investigations, to demonstrate safety and performance of a device for its intended purpose throughout its lifecycle.

Testing devices at elevated stress or cycling rates to estimate long-term reliability within a shorter period, with results extrapolated using an appropriate failure model.