ASM has released a number of additions to the Materials for Medical Devices database
New ISO Standard Added
ISO 10993 Biological Evaluation of medical devices – Part 18: Chemical characterization of materials
Characterization of medical device materials is clearly identified as one of the first steps in ISO 10993’s overall evaluation. ISO 10993- Part 1 “Guidance on Selection of Tests” states that “in the selection of material to be used in device manufacture, the first consideration should be fitness for purpose having regard to the characteristics and properties of the material, which include chemical, toxicological, physical, electrical, morphological, and mechanical properties”.
This latest version of the database features all the new PMA and 510(k) approvals up to November 12th, 2008, in both the Orthopaedic and Cardiovascular modules, fully integrated for ease of searching, and linked to materials and supplier data.
New Materials with Bioresponse Information Added:
* Demineralized Bone Matrix
* Poly(ester urethane urea)
* Hydroxyapatite, Silicon Substituted
* Hydroxyapatite/Tricalcium Phosphate
* Tricalcium Phosphate
* Intra-Aortic Balloon (General) 870.3535
* Phalangeal (General) Toe 888.3730
* Semi Constrained (General) Ankle 888.3110
New Database Functionality Added
There is a new function in the database that allows the user to see a list of materials used in a chosen Device Category (e.g.. Spinal, Hips, Knees etc). See below!
To use this new functionality:
1. Click on "Select" button and choose "Materials" Table and "All Materials" Subset then click GO
2. Don't enter anything in "Required Properties” section, just click GO again (bottom right hand side of screen) to have a list of all materials.
3. Click on "Advanced Selection" in the upper right-hand corner (located in the black tab area)
4. About half way down the page, go to the “Cross-tabular selection…” area just below the gray spreadsheet
5. Open "Devices" section by clicking on the “crossbar”.
6. Click on “General Information”. You will then see a drop down box on the right hand side of the screen. You can then choose a category of interest e.g. Orthopaedic-Hips
7. Click GO on the bottom of the page and list of materials used in Hips devices will appear on the left hand pane
8. You can save this information, place it in a report or modify your search accordingly.