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BSI 20/30400340 DC 2020

BSI 20/30400340 DC 2020

$13.70

BS ISO 25539-4. Cardiovascular implants. Endovascular devices – Part 4. Application of ISO 17327-1 for coated endovascular devices

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BSI 2020 20
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Part 4 of ISO 25539 specifies the appropriate application of ISO 17327-1:2018, Non-active surgical implants — Implant coating —Part 1: General requirements, to coated endovascular prostheses, vascular stents, and vena cava filters. Part 4 of ISO 25539 should be considered as a supplement to ISO 25539-1, ISO 25539-2, ISO 25539-3, ISO 12417-1 and ISO 17137.

The following coatings are within the scope of ISO 17327-1 and addressed in this standard for endovascular devices: drug coatings (eluting and non-eluting), non-drug coatings (absorbable and non-absorbable), and chemistry-related surface modifications (oxide(e.g. TiO2) and non-oxide(e.g. amorphous silicon carbide, diamond-like carbon)).

This standard is not applicable to coated delivery systems or coated ancillary devices (e.g. guidewires), as these coatings are not within the scope of ISO 17327-1, which is specifically directed to implant coatings.

This document is not applicable to coverings of endovascular devices; however, if the covering of a device is coated it is within the scope of this part of ISO 25539.

This standard does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used as implant coatings.

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BSI 20/30400340 DC 2020
$13.70