Norm

ASTM F2914-12

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

54,27

Over deze norm

Status Definitief
Aantal pagina's 6
Commissie F04.30
Gepubliceerd op 15-01-2012
Taal Engels

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 and health practices and determine the applicability of regulatory limitations prior to use.

Details

ICS-code 11.040.40
Nederlandse titel Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
Engelse titel Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices

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