Ergonomic Crutches Design for Enhanced Mobility and Comfort

Ergonomic Crutches Design for Enhanced Mobility and Comfort

Design for ISO testing compliance

Device Contact Type and Duration:

Type of Contact: The crutches come into contact with skin, hand, and possibly underarm.
Contact Duration: Depending on intended use, the crutch could have:
Limited Contact: ≤ 24 hours per day
Prolonged Contact: >24 hours up to 30 days (if used frequently).
ISO 10993 Biocompatibility Tests Depending on the nature of contact, relevant chapters/tests may include:

Cytotoxicity - ISO 10993-5:
Assesses the capability to cause the death of cells or cellular damage. This research is accordingly necessary to make sure that no materials being used are cytotoxic.
Sensitisation (ISO 10993-10):
Performs skin sensitization testing to ensure that materials are not allergenic.
Irritation/Intracutaneous Reactivity (ISO 10993-10):
It checks the irritation responses-that is, the kind of redness and swelling the device induces when in contact with the skin.
Acute Systemic Toxicity ISO 10993-11:
Provides an assessment of systemic toxicity that can result from acute exposure to any extractables.
Material Characterization (ISO 10993-18):
Assesses chemical composition regarding hazardous substances in all kinds of materials.
Testing Process:

Material Selection:
The material characterization shall be carried out in order to identify the chemical composition of all the components that come into contact with the skin.
Sample preparation:
Ensure that test samples accurately represent the materials and production processes used in your design.
Biocompatibility Testing:
Cytotoxicity Test: The cells should be grown in contact with the material device to test their viability and growth. Sensitization Test: The extracts from the material are applied to the animal models or other validated in-vitro methods to check the sensitization responses. Irritation Test: Apply the device material directly or via extracts on skin to test for localized irritation. Acute Systemic Toxicity Test: This test involves the injection or exposure of the test subject to the extracts of the device and observing systemic adverse effects on health.