ASTM-F2743 2011

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F2743-11 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems

Published By	Publication Date	Number of Pages
ASTM	2011	10

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

ASTM F2743-11

Historical Standard: Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems

ASTM F2743

Scope

1.1 This guide describes recommended in vitro test procedures for coating inspection and acute particulate characterization of coated drug-eluting vascular (balloon-expandable and self-expanding) stent systems.

1.2 Recommended practices for coating inspection and acute particulate characterization include baseline (deployment) testing and simulated use testing. This guide describes the capture and analysis of particulates. This guide describes the inspection of the coated stent surface. This guide was developed for characterization and not intended for production release testing of coated drug-eluting vascular stent systems although some sections may be appropriate.

1.3 Chronic particulate characterization and coating inspection are not included herein.

1.4 Coating systems specifically designed to degrade or otherwise intentionally separate themselves from the permanent stent structure may not be fully addressed herein.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

Keywords

baseline; coating inspection; DES; drug-eluting vascular stent; particulate; particulate characterization; simulated use

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F2743-11

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology Summary of Practice
2	Significance and Use Suggested Materials and Reagents
3	Test Method Considerations TABLE 1
4	TABLE 2 TABLE 3 TABLE 4
5	Suggested Generic Test Methods TABLE 5
6	TABLE 6
7	Report Keywords
8	X1. SEM PHOTOGRAPHS OF ANOMALIES AND DEFECTS X1.1 FIG. X1.1 FIG. X1.2
9	FIG. X1.3 FIG. X1.4
10	FIG. X1.5 FIG. X1.6

Additional information

Standard Title	F2743-11 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
Published Code	ASTM
Publication Date	2011
Pages Count	10
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics