ISO 25539-2-2012 pdf free download.Cardiovascular implants – Endovascular devices – Part 2: Vascular stents Part 2: Vascular stent.
6.2 DelIvery system and stent system
The design attributes to meet the intended performance of the detivery system shel adclaionally take flto account at least the lollo*ing:
a) the ability of the system to permit coneisterit, accurate and safe access to the aitended loca1on
b) the ability of the system to permit consistent, accurate and safe deployment of the stern.
c) the ability of the system to permit consistent and sale withdrawal of the defivery system:
d) the covnphanc. of th syst.m with the requiremerits of ISO 10993.1 and approial. other parts 01 Ih. ISO 10993 series 01 international Standards (bloconipetibihity):
e) the abilIty of the system to minimize blood loss (haemostaais).
1) vnibibly of h $y$tthYl under %,aoroscopy or other tectrioingies
6.3 Implant
6.3.1 Stent
The design attrit,ut.s to meet the intended p.rformano. of the slant altal edifitionely take Ito account best the folIowrng
a) th, ability of th, slant to b. oonsist.iitiy, accurately and safely deployed;
b) the attietyof the alert to ensure efJecI.e hzation and posIrion m the intended location wttwi the ycLiatts’e,
C) the ability of the s$nt to maintain adequate wit.gr*y;
d) the consistency of the stent dimensions and Its design for conipatIilIty for use In specified vesaei diameters;
a) the ability of the stent maintain adequate blood flow throu the itimen ipatericy):
I) the ccwnp.tibaty of the slant with exposur, to magnetic resonance Imaging (t.ief I) fields;
g) the compliance of the stern with the requwements of iSO 10993-1 and apopnale other perts of the iSO 10993 series 01 international Standards (bucompatibilily);
h) the vsibály of the stern under fluoroscopy or other technologies
•.32 Coaling
The design attributes to meet the r.tendad performance of the coating shall addltionaly take Wito account at least the following
a) the atiilty of the coalmg to masilawi adequate Wltegnty over bme according to design specthcaticris (.g freedom from .igivflcant de4eminabon, flaps and bare spots);
b) the appropriate reeraction between the coating and the slant (a g, coating .*iencad corrosion of the substrate);
c) the ability of the coating to rnisntain adequate resistance to uniritanded particulat. generation:
d) the conformance of thecoatingdirnenslons and other coatwig parameters (e.g porosity, density, detrieution) to the design requiramentac
e) the eftect of P.1 RI on the coatIng of a coaled stent (e.g. heatlnq).ISO 25539-2 pdf download.