Customer Support: +1 416-401-8730

Login to i2i Subscription Intertek.com
  • There are no items in your cart
Please enter a keyword to search
Advanced search

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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
Available format(s)

Hardcopy , PDF

Superseded date

11-20-2018

Language(s)

English

Published date

10-01-2011

Publisher

American Society for Testing and Materials

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.

1.1 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.

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Superseded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

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

View more information
US$75.00
Excluding Tax where applicable
USD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us