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Design & Construction Requirements

Chemical, physical, and biological properties​

Devices must be designed and manufactured to minimise risks associated with their chemical, physical, and biological properties. Specific requirements:

Biological safety (biocompatibility)​

Devices that come into contact with the patient's body must be biocompatible. Materials must be selected considering:

  • Toxicity (cytotoxicity, sensitisation, irritation)
  • Biodegradation products
  • Contaminants and residues
  • Mutagenicity and carcinogenicity (for long-term contact)

Key standard: ISO 10993 series — Biological Evaluation of Medical Devices

Chemical properties​

  • Leachable substances must be assessed and controlled
  • Devices should not release substances in quantities likely to cause harm

Infection and microbial contamination​

Devices must be designed to minimise the risk of infection:

  • Devices supplied sterile must maintain sterility until the point of use
  • Sterility must be achieved using validated sterilisation processes
  • Packaging must maintain sterility under normal handling and storage conditions
  • Devices intended to be sterilised by the user must provide instructions for validated sterilisation methods

Key standards:

  • ISO 11135 — Sterilisation by ethylene oxide
  • ISO 11137 series — Sterilisation by radiation
  • ISO 17665 — Sterilisation by moist heat

Devices with a measuring function​

Devices with a measuring function must:

  • Achieve measurement accuracy appropriate to the intended purpose
  • Express measured values in SI or other legally recognised units
  • Have appropriate scales and displays for the intended user

Protection against electrical hazards​

Electrical devices must:

  • Protect against electric shock
  • Protect against fire and excessive temperatures
  • Protect against electromagnetic interference (EMI)
  • Function safely in reasonably foreseeable electromagnetic environments

Key standards: IEC 60601 series — Electrical Safety for Medical Electrical Equipment

Software requirements​

Devices incorporating software must ensure:

  • The software performs its intended function reliably
  • Software failures are detected and managed appropriately
  • The software lifecycle is documented and controlled

Key standard: IEC 62304 — Software Lifecycle Processes for Medical Device Software

Mechanical properties​

Devices must be designed to withstand the mechanical stresses associated with their intended use, including:

  • Forces applied during normal use
  • Forces applied during reasonably foreseeable misuse
  • Vibration and transport stresses

Shelf life and degradation​

Devices must maintain their safety and effectiveness characteristics throughout their stated shelf life, considering:

  • Deterioration of device materials
  • Environmental conditions during storage and transport
  • The effects of sterilisation processes (for sterile devices)

Legislative source: Medical Devices Regulations, SOR/98-282, Schedule 1, Part 1 (ss 3–9)