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AAMI ISO TIR17137 pdf free download

AAMI ISO TIR17137 pdf free download.Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants.
4 Implant considerations 4.1 Classification A cardiovascular absorbable implant is a product that is considered to be a medical device that accomplishes its intended clinical use and performance over a defined time period. A cardiovascular absorbable implant accomplishes its intended clinical use and is then absorbed by the body over a finite period of time. The implant’s temporary nature is provided by its ability to degrade and the resulting products’ ability to be metabolized, assimilated, and/or excreted (eliminated) over time. An absorbable cardiovascular implant may also incorporate a medicinal substance. However, for the purposes of this Technical Specification, if the action of the medicinal substance is ancillary to a device’s primary mode of action, the product is considered to be a surgical implant. The manufacturer shall determine the acceptability of the product for clinical use at all stages of the product life cycle. 4.2 Intended clinical performance The intended performance of an absorbable implant shall be described and documented by addressing at least the following, with particular regard to patient’s safety: a) intended purpose(s); b) intended lifetime.
5 Design verification and validation — Testing and analysis 5.1 Overview A general characterization of the implant’s composition, structural features, and degradation properties needs to be included in a design verification or validation. The relevant material and mechanical properties of the as- manufactured implant should be characterized from its initial pre-implanted state until measurement of the degraded implant becomes impractical. An overview of the assessment guidance provided herein is as follows: — Clause 5.2 Summarizes the in vitro evaluation steps and describes general considerations and relevant pre-test characterizations and treatments. — Clause 5.3 guides product assessment from opening of the package through simulated vessel closure, which includes the delivery, placement, and initial function of the device (depicted as Procedural Stage in Figure 2). — Clause 5.4 addresses appropriate characterization of the post-procedure mechanical, dimensional, mass, and chemical changes that occur as the implant (and any included coating) adjust to the physiological environment and encounter degradation over time (depicted as the Intermediate Stage in Figure 2). — Clause 5.5 discusses some of the issues and potential barriers to successful generation of a correlation between in vitro and in vivo results. — Clause 5.6 describes biocompatibility testing of absorbable implants, including reference to specific guidance for testing in accordance with the various parts of ISO 1 0993. — Clause 5.7 covers both cardiovascular and absorbable specific concerns when conducting a pre-clinical in vivo evaluation. — Clause 5.8 covers absorbable-specific concerns when conducting a clinical evaluation — Clause 5.9 covers shelf-life and product aging considerations.In this example figure, the decline in mechanical attributes is schematically represented through time (“Intermediate Stage”) in comparison with the time frame for implantation (“Procedural Stage”) and the period between loss of mechanical integrity and final in vivo resolution of the implant (“Advanced Stage”). The degradation profile for some materials may exhibit alternate trends but generally will include a decay to measurement limits. Relevant non- mechanical attributes should also be monitored at pertinent evaluation intervals, potentially throughout both the Intermediate and Advanced stages of degradation. Also, note that the graphically depicted Measurement Limit and Acceptance Criteria are hypothetical values that will vary dependent on measurement methods and the specific product’s characteristics and performance requirements.AAMI ISO TIR17137  pdf download.

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