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ASTM F 2743 : 2011

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s)

Hardcopy , PDF

Superseded date

20-11-2018

Language(s)

English

Published date

01-10-2011

€67.30
Excluding VAT

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.

Committee
F 04
DocumentType
Guide
Pages
10
ProductNote
THIS STANDARD ALSO REFERS TO USP <788>,FDA Guidance for Industry and FDA Staff
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

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.

PD ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
AAMI ISO TIR 17137 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS
ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
ASTM F 3320 : 2018 Standard Guide for Coating Characterization of Drug Coated Balloons

AAMI TIR42 : 2010 EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES

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