By Michael N. Helmus
This e-book highlights the accountability of clinical gadget designers and engineers to cast off websites of failure and to check units to illustrate their final security and efficacy. It additionally evaluates biomaterials and their homes as on the topic of the layout and reliability of clinical units. the rules which are defined are quite simply appropriate to the biomaterial scaffolds used for producing tissue-engineered constructs.
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Extra resources for Biomaterials in the Design and Reliability of Medical Devices
Sample text
Also, the 510k paradigm document has been finalized10 and provides for two faster “gateways for approval: “special 510K” and "abbreviated 510K". The “special 510K” is available if the device is a modification of a predicate device and entails submission of summaries of design control compliance. Devices that include changes in energy sources, software and dimensions are suitable for this pathway. The “abbreviated 510k" is available to devices that are amenable to device-specific guidance documents, special controls, or FDArecognized consensus standards.
The guidance refers to ISO documents that define implant devices, ISO 10993-1, and are useful in defining biocompatibility tests. The guidance addresses material use that is supplied by specification and states: Is the new material being supplied to a specification? If the material is being supplied to the device manufacturer’s specification, a 510(k) is probably not necessary. For example, a device manufacturer might include a transparency requirement in the purchase specification for tubing to be used in an implantable catheter.
Monorail (wire through proximal third of length rather than entire catheter length) designs • Balloon inflation of stents These requirements will influence the design and materials required. Many times tradeoffs are required to meet the most important property. Many of the balloons used are made of radiation cross-linked polyethylene or polyolefin compolymers. They are more compliant than polyester balloons, conform to the shape of the stenosis but exhibit some creep and lower burst strength than polyester balloons.