Wrist Brace design

Wrist Brace design

Design for ISO testing compliance

Relevant ISO standards that the wrist brace design should comply:
ISO 13485-This standard specifies requirements for a quality management system (QMS) for medical devices. It ensures consistent product quality, safety and efficacy.
IS0 14971- This standard provides requirements for the application of risk management to medical devices. It helps identify and mitigate potential risks associated with the device.
ISO 10993-This standard addresses the biological safety of medical devices. It includes testing for biocompatibility, cytotoxicity and sensitization.
Steps in considering for ISO compliance:
1.Risk management(ISO 14971)

  • Hazard identification- Potential hazards associated with the wrist brace, such as skin irritation, allergic reactions and improper fit is identified.
  •  Risk assessment- The severity and likelihood of each identified hazard is evaluated.
  • Risk control- Measures to mitigate or eliminate risks, such as using biocompatible materials, providing clear instruction and ensuring the brace is proper fit is implemented

2. Biocompatibility(ISO 10993)

  • Cytotoxicity- Materials ability to cause cell death is tested.
  • Sensitization – The potential for allergic reactions is evaluated.
  • Irritation- Materials of the design is assessed if it causes skin irritation.

3.Clinical evaluation(ISO 13485)

  • User studies- clinical trials is conducted to assess the brace’s effectiveness, safety and user satisfaction.

Testing for ISO compliance:
4.Mechanical testing

  • Tensile strength- determine the maximum load the design can withstand before breaking under a tensile load
  • Fatigue testing- evaluate the design’s resistance to repeated loading and unloading cycles.
  • Flexural strength- measure the maximum bending stress a material can withstand before breaking.
  • Impact resistance- assess the material’s ability to withstand a sudden load or shock.

5.Biocompatibility testing

  • In vitro cytotoxicity testing- evaluating materials direct toxicity to cells in a laboratory setting
  • In vivo sensitization and irritation- assessing material’s potential to cause allergic reactions or skin irritation in different animals/specimen.