Description of device
Surgical sutures, also known as stitches, are used to hold body tissue/wounds together after surgery or an injury to aid recovery. They can come in many different materials and sizes depending on the application. Sutures generally fall into two categories, absorbable and non-absorbable, and are often applied with a stainless steel needle.
Sutures are generally in place for a few weeks, but during a persons life time a patient may require a number of different stitches.
Sutures are very common medical devices with millions of sutures used each year and a market size of 4.4 billion per year.
Specific Sample Related Considerations for Chemical Characterisation
- Material of Construction: polymeric and metal material – small surface area likely to result in lower extractable levels ↓
- Analytical Limits: low due to prolonged contact, therefore a sample concentration is required↑
- Extraction Type: exaggerated extraction which can further affect analytical limits and requires additional time and testing ↓
- Overall chemical characterisation complexity rating = 5
Key Factors for Chemical Characterisation
- Related Guideline – 10993-18
- Extraction Type – Exaggerated (if non-absorbable), dissolution (if absorbable)
- Solvents – 3 (polar, semi-polar, non-polar)
- Typical Sample Size – Small (<10cm2)
- Extraction volume 10 mLAnalytical Limits (without concentration) = 0.015 µg/mL