and a possible product recall. Having a correct chemical signature for the correct materials used for the device allows a replacement material to be employed without the expense of full biocompatibility testing.
Table II: Relevant parts of ISO 10993, Biological Evaluation of Medical Devices
• ISO 10993-14:2001, Biological Evaluation of Medical Devices, Part 14: Identification and Quantification of Degradation Products from Ceramics
• ISO 10993-15:2000, Biological Evaluation of Medical Devices, Part 15: Identification and Quantification of Degradation Products from Metals and Alloys
• ISO 10993-16:1997, Biological Evaluation of Medical Devices, Part 16: Toxicokinetic Study Design for Degradation Products and Leachables
• ISO 10993-17:2002, Biological Evaluation of Medical Devices, Part 17: Establishment of Allowable Limits for Leachable Substances
• ISO 10993-18:2005, Biological Evaluation of Medical Devices, Part 18: Chemical Characterisation of Materials
• ISO/TS 10993-19:2006, Biological Evaluation of Medical Devices, Part 19: Physico-Chemical, Morphological and Topographical Characterisation of Materials
Controlled Environment
References
1. B. Sandán et al., “Hydroxyapatite Coating Improves Fixation of Pedical Screws,” British Editorial Society of Bone and Joint Surgery, 84-B, 3 (2002),
web.jbjs.org.uk/cgi/reprint/84-B/3/387. pdf.
2. A.G.Werner, “Short Classification and Description of the Various Rocks” (1786).
3. F.H. Albee, “Studies in Bone Growth: Triple Calcium Phosphate as a Stimulus to Osteogenesis,” Ann. Surg., 71, 1, 32–39 (1920).
4. L.L. Hench, J. Wilson, “An Introduction to Bioceramics,” World Scientific Publishing Co. Pte. Ltd, Singapore (1993).
5. R.J. Furlong, J.F. Osborn, “Fixation of Hip Prostheses by Hydroxyapatite Ceramic Coatings,” J. Bone and Joint Surg., 73-B, 3, 741–745 (1991).
6. ASTM International
www.astm.org.
7. Guidance document for Testing Biodegradable Polymer Implant Devices,
www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/
ucm080265.htm.
8. ASTM F2150-08, Standard Guide for Characterisation and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products.
9. Transdermal Delivery Systems – General Drug Release Standards,
www.pharmacopeia.cn/v29240/usp29nf24s0_c724hs30.html.
Mark Turner is Sales Director at Medical Engineering Technologies Ltd, Yew Tree Studios, Stone Street, Stanford North, Ashford TN25 6DH, UK, tel. +44 (0)8454 588 924, e-mail:
m.turner@met.uk.com www.met.uk.com
www.med-techinnovation.com
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April 2011 ¦ 29 CNC Tooling
Computer Aided Design
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