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1.1 This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro...
1.1 This guide covers the identification of and recommended measurement methods for those dimensional attributes of vascular stents that are deemed relevant to successful clinical performance. The delivery system packaged with and labeled specifically for use during the placement of the stent is...
1.1 This document provides guidance for developing in vitro test methods for measuring the radial strength or collapse pressure of balloon-expandable vascular stents and chronic outward force of self-expanding vascular stents. 1.2 This guide is applicable to balloon-expandable and self-expanding...
1.1 This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional. 1.2 This guide does not address flat plate, local crush durability, or multi-mode testing. Although this guide does not address multi-mode testing, the information...
This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional. This guide does not address flat plate, local crush durability, or multi-mode testing. Although this guide does not address multi-mode testing, the information included...
5.1 The shedding of the coating from a vascular stent can alter its clinical safety and/or therapeutic benefit. Clinical performance (for example, drug elution) may be affected by particulate generation from the coated stent system and coating defects. This document provides guidance for coating...
5.1 The methods described herein allow for in-vitro characterization of DCB drug coating attributes that, along with pre-clinical and clinical safety and effectiveness data, establish that the DCBs, with the characterized coating attributes, are safe and effective. Clinical safety and therapeutic...
5.1 Use of this Methodology: 5.1.1 This guide provides a compendium of information on methods to use fracture data, fatigue life models, and statistical techniques to estimate the structural fatigue durability of an implantable medical device under anticipated in vivo loading modes. The methodology...
1.1 This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro...
1.1 This guide covers the identification of and recommended measurement methods for those dimensional attributes of vascular stents that are deemed relevant to successful clinical performance. The delivery system packaged with and labeled specifically for use during the placement of the stent is...
ISO 22401:2015 provides a test method to measure spray sedimentation from horizontal boom sprayers using a test bench. The sedimentation measure gives a value for potential spray drift. These measurements can be used to compare different sprayer setups on the same sprayer. ISO 22401:2015 is...
This International Standard provides a test method to measure spray sedimentation from horizontal boom sprayers using a test bench. The sedimentation measure gives a value for potential spray drift. These measurements can be used to compare different sprayer setups on the same sprayer. This...
1.1 This document provides guidance for developing in vitro test methods for measuring the radial strength or collapse pressure of balloon-expandable vascular stents and chronic outward force of self-expanding vascular stents. 1.2 This guide is applicable to balloon-expandable and self-expanding...
5.1 It is important to consider the durability of stent designs in deformation modes that are intended to model in vivo conditions. The appropriate amplitude and number of cycles in each of the modes has to be determined independently for the particular clinical use proposed for the stent. These...
This Part of ISO 22369 specifies the drift classification procedure for field crop sprayers by the measurement of potential spray drift with the use of a test bench and it allows the allocation of the spray drift reduction classes specified by ISO 22369-1. This International Standard is...
1.1 This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro...
1.1 This guide covers the identification of and recommended measurement methods for those dimensional attributes of vascular stents that are deemed relevant to successful clinical performance. The delivery system packaged with and labeled specifically for use during the placement of the stent is...
The shedding of the coating from a vascular stent can alter its clinical safety and/or therapeutic benefit. Clinical performance (for example, drug elution) may be affected by particulate generation from the coated stent system and coating defects. This document provides guidance for coating...
1.1 This test method covers procedures for the determination of the biodegradability or removability, or both, of nonvolatile organic chemicals (Henry's Constant <10−3 atm/m3/day) using a laboratory bench scale test and activated sludge from a domestic wastewater treatment plant. 1.2 This...
