ПЭЭК Трубка катетера PEEK

ARK-BioPEEK

Катетерная трубка PEEK представляет собой термопластичный полимер, который может быть экструдирован в катетерную трубку с требуемыми свойствами, такими как высокая прочность на растяжение, сопротивление изгибу, хорошая проталкиваемость и рентгеноконтрастность.

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BIOMATERIAL PROPERTY

Properties Information
Property		Reference Standard	Test Method	Unit	Specification	Result
Physical Properties	Glass Transition	ASTM F2026	ASTM D3418	°C	125-165	147
	Temperature, T_g	ASTM F2026	ASTM D3418	°C	125-165	147
	Melt Temperature, T_m	ASTM F2026	ASTM D3418	°C	320-360	338
	Recrystallization	ASTM F2026	ASTM D3418	°C	260-320	289
	Temperature, T_c	ASTM F2026	ASTM D3418	°C	260-320	289
	Viscosity	ASTM F2026	ISO 11443	Pa·s	400-480	437
	Infrared Spectrum	ASTM F2026	ASTM F1579	/	See Appendix X1	See Appendix X2
	Density	ASTM F2026	ASTM D1505	kg/m³	1280-1320	1294
Chemical Properties	Total Heavy Metals (Ag, As, Bi, Cd, Cu, Hg, Mo, Pb, Sb, and Sn), max	ASTM F2026	US Pharmacopeia,	ppm	<100	＜10
Chemical Properties		ASTM F2026	Test 233	ppm	<100	＜10
Mechanical Properties	Tensile Strength at Yield (zero slope), min	ASTM F2026	ASTM D638, Type IV, 5.08 cm/min	MPa	90	105
	Tensile Strength at Break, min	ASTM F2026	ASTM D638, Type IV, 5.08 cm/min	MPa	70	80
	Elongation at Break, min	ASTM F2026	ASTM D638, Type IV, 5.08 cm/min	%	5	18
	Flexural Strength, min	ASTM F2026	ASTM D790	MPa	110	163
	Flexural Modulus, min	ASTM F2026	ASTM D790	GPa	3	4
	Impact Strength,	ASTM F2026	ISO 180	kJ/m²	4	9
	Notched Izod, min	ASTM F2026	ISO 180	kJ/m²	4	9
Biological Properties	Genotoxicity	ISO 10993-3	ISO 10993-3	/	Negative	Negative
	Animal Intracutaneous (Intradermal) Reactivity	ISO 10993-10	ISO 10993-10	/	≤1	0
	Skin Sensitization	ISO 10993-10	ISO 10993-10	/	≤1	0
	Acute Systemic Toxicity	ISO 10993-11	ISO 10993-11	/	No Acute Systemic Toxicity	No Acute Systemic Toxicity
	Subchronic Systemic Toxicity	ISO 10993-11	ISO 10993-11	/	No Subchronic Systemic Toxicity	No Subchronic Systemic Toxicity
	local Effects After Implantation	ISO 10993-6	ISO10993-6	/	No obvious difference between the test sample and the control sample	No obvious difference between the test sample and the control sample
	In Vitro Cytotoxicity	ISO 10993-5	ISO10993-5	/	≤1	1
	Evaluation of Haemolytic Properties	ISO 10993-4	ISO10993-4	%	＜5	1
	Material Mediated Pyrogens	ISO 10993-11	ISO 10993-11	/	No Pyrogenic Responses	No Pyrogenic Responses
	Extractables of The Material	ISO 10993-18	ISO 10993-18	μg/g	The contents of Phenyl Sulfone≤300	The contents of Phenyl Sulfone＜0.09

ТЕГИ: ARKMED/ ARK-BioPEEK