ASTM F2914 - 12(2018) - Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices

ASTM F2914 - 12(2018)

Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices

Status : Current   Published : November 2018

Format
PDF

Format
HARDCOPY



1.1 This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example drug-devices, biologic devices or drug biologics) may require additional considerations, depending on their nature.

1.2 This guide does not directly provide any test methods for conducting shelf-life testing.

1.3  This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.4  This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.




Standard NumberASTM F2914 - 12(2018)
TitleStandard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
StatusCurrent
Publication Date01 November 2018
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors aging, establishment, shelf life, shelf-life, stability
ICS11.040.40
PublisherASTM
FormatA4
DeliveryYes
Pages6
File Size164 KB
Price£40.00


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