X-medics Newsletter December 2015
2015 has been a positive year for X-medics, and to judge form the received business, it has been a positive year for many of our customers as well. We have in 2015 worked closely together with customers and suppliers to further develop our product quality, product offering, quality documentation and customer service in order maintain a leading position in the industry.
Read more about:
- Tantalum beads – Improved finish and more products
- Tantalum beads – 3rd party material and biocompatibility testing is now standard
- Tantalum beads – ASTM F86 cleaning now standard
- Improved tolerances on tantalum wire and rods
- Improved packaging
Improved tolerance and documentation of beads/balls – and more products
We have in 2015 made efforts to further improve our product program of beads/balls concerning product quality, tolerance and availability.
Improved finish and more products: For 0.80mm (0.0315”) beads and 1.00mm (0.0394”) beads the ball surface finish has been improved and all offered balls now confirms to AFMBA Grade 50 (tolerance +/- 0.005 mm (0.0002″)). We have added 1.60mm (0.0623”) balls of similar quality as a standard product. Together with customers we are working on further expanding the beads
programme, so we can offer small diameter beads like e.g. 0.0155” (0.394 mm) directly from stock as well.
3rd party material and biocompatibility testing
The documentation has been improved so each production batch comes with independent 3rd party testing of processing materials and surface purity after processing. The surface purity evaluation is now made by means of ISO 10993-5 cytotoxicity testing for biocompatibility verifying that harmful substances do not remain after processing. All testing are made by independent ISO 17025 accredited laboratories.
ASTM F86 cleaning
All products are further delivered cleaned by ASTM F86 procedure (standard cleaning procedure for surgical implants) being
performed by a specialised ISO 13485 certified medical device cleaning company
Improved tolerances on wire and rods
We have during the last years seen interest for higher tolerance products among our customers and have expended product offering to fulfil market needs. For strengthened rods in 3 ft (0.914 mm) length we have added a series of high tolerance rods (-0.005/+0.010 mm) to our standard +/- 0.020 mm tolerance rods. For wire on spool different tolerance requirements can be met down to +/-0.005 mm.
We have in 2015 experienced a few instances of product damaging during shipping which has lead to re-evaluation of our packaging methods. More durable packaging materials have been applied for some products. The change will not lead to higher handling nor shipping costs to customers.
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