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ASTM F2081-06(2022)

(Guide)

Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

SIGNIFICANCE AND USE
4.1 Vascular stents are intended for permanent implant in the human vasculature (native or graft) for the purposes of maintaining vessel patency. The dimensional attributes of vascular stents are critical parameters that aid clinicians in the selection of devices for individual patients. This guide contains a listing of those dimensional attributes that are directly related to the clinical utility and performance of these devices, along with recommendations for consistent methods of measuring these attributes and presenting the information for use in clinical decision making. This guide can be used by the manufacturers and researchers of stents to provide consistency of measurement and labeling of these dimensional characteristics. It may have use in the regulation of these devices by appropriate authorities.  
4.2 The dimensional attributes included in this guide are those that are deemed related to or possibly predictive of successful clinical performance of the stent based on prior clinical experience; however, because of the myriad patient and medical factors that influence the clinical outcome of any individual treatment, conformance of a stent and delivery system with the recommendations in this guide should not be interpreted as a guarantee of clinical success in any individual patient or group of patients.
SCOPE
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 also included within the scope of this guide.  
1.2 This guide addresses only the dimensional characteristics of stents. Material property and stent functional characteristics are not addressed herein. All dimensional characteristics described in this guide refer to in vitro (“bench-top”) characterization. Because of variable patient factors, for example, vessel compliance, the actual in vivo characteristics may be slightly different.  
1.3 This guide includes recommendations generally applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents or polymeric or biodegradable stents, although the application of this guide to those products is not precluded.  
1.4 While they are not specifically included within the scope of this guide, stents indicated for placement in nonvascular locations, such as the esophagus or bile duct, also might be characterized by the methods contained herein. Likewise, this guide does not include recommendations for endovascular grafts (“stent-grafts”) or other conduit devices commonly used to treat aneurysmal disease or peripheral vessel trauma or to provide vascular access, although some information included herein may be applicable to those devices.  
1.5 This guide does not include recommendations for balloon catheters sold as stand-alone angioplasty catheters, even though some of those catheters may be used for the delivery of unmounted stents supplied without a delivery system. Requirements for angioplasty catheters are contained in standards ISO 10555-1 and ISO 10555-4.  
1.6 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
1.6.1 The units of measurements used throughout this guide reflect the hybrid system in common clinical use in the United States as of the time of the original approval of this guide. Since a primary purpose of this guide is to promote uniformity of labeling to facilitate the selection of devices by clinical users, the units most prefer...

General Information

Status
Published
Publication Date
30-Sep-2022
ICS
11.040.20 - Transfusion, infusion and injection equipment
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.30 - Cardiovascular Standards
Current Stage
Ref Project

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ASTM F2081-06(2022) - Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular StentsASTM F2081-06(2022) - Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
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ASTM F2081-06(2022) - Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
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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.
Designation: F2081 − 06 (Reapproved 2022)
Standard Guide for
Characterization and Presentation of the Dimensional
1
Attributes of Vascular Stents
This standard is issued under the fixed designation F2081; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.6 The values stated in either SI units or inch-pound units
are to be regarded separately as standard. The values stated in
1.1 This guide covers the identification of and recom-
each system are not necessarily exact equivalents; therefore, to
mended measurement methods for those dimensional attributes
ensure conformance with the standard, each system shall be
of vascular stents that are deemed relevant to successful
used independently of the other, and values from the two
clinical performance. The delivery system packaged with and
systems shall not be combined.
labeled specifically for use during the placement of the stent is
1.6.1 The units of measurements used throughout this guide
also included within the scope of this guide.
reflect the hybrid system in common clinical use in the United
1.2 This guide addresses only the dimensional characteris-
States as of the time of the original approval of this guide.
tics of stents. Material property and stent functional character-
Since a primary purpose of this guide is to promote uniformity
istics are not addressed herein. All dimensional characteristics
of labeling to facilitate the selection of devices by clinical
described in this guide refer to in vitro (“bench-top”) charac-
users, the units most preferred by users were selected for this
terization. Because of variable patient factors, for example,
guide. Where those units are not SI units, or derivatives
vessel compliance, the actual in vivo characteristics may be
thereof, SI units are provided in parentheses.
slightly different.
1.7 This international standard was developed in accor-
1.3 This guide includes recommendations generally appli-
dance with internationally recognized principles on standard-
cable to balloon-expandable and self-expanding stents fabri-
ization established in the Decision on Principles for the
cated from metals and metal alloys. It does not specifically
Development of International Standards, Guides and Recom-
address any attributes unique to coated stents or polymeric or
mendations issued by the World Trade Organization Technical
biodegradable stents, although the application of this guide to
Barriers to Trade (TBT) Committee.
those products is not precluded.
2. Referenced Documents
1.4 Whiletheyarenotspecificallyincludedwithinthescope
2
of this guide, stents indicated for placement in nonvascular
2.1 ISO Standards:
locations, such as the esophagus or bile duct, also might be
ISO 10555-1 Sterile, Single-Use Intravascular Catheters—
characterized by the methods contained herein. Likewise, this
General Requirements
guide does not include recommendations for endovascular
ISO 10555-4 Sterile, Single-Use Intravascular Catheters—
grafts (“stent-grafts”) or other conduit devices commonly used
Balloon Dilation Catheters
to treat aneurysmal disease or peripheral vessel trauma or to
provide vascular access, although some information included
3. Terminology
herein may be applicable to those devices.
3.1 Definitions of Terms Specific to This Standard:
1.5 This guide does not include recommendations for bal-
3.1.1 balloon-expandable stent, n—a stent that is expanded
loon catheters sold as stand-alone angioplasty catheters, even
at the treatment site by a balloon catheter. The stent is altered
though some of those catheters may be used for the delivery of
permanently by the balloon expansion such that the stent
unmounted stents supplied without a delivery system. Require-
remains expanded after deflation of the balloon.
ments for angioplasty catheters are contained in standards ISO
3.1.2 bridge, n—a connecting element between the radial
10555-1 and ISO 10555-4.
support aspects of a stent. A bridge may have unique design
features, as compared to a strut, to enhance longitudinal
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
flexibility and minimize shortening.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.30 on Cardiovascular Standards.
Current edition approved Oct. 1, 2022. Published October 2022. Originally
2
approved in 2001. Last previous edition approved in 2017 as F2081 – 06 (2017). Available from American Natio
...

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4.1 The securement of the endovascular stent on the balloon is a critical parameter to ensure that the stent is safely delivered to or from the treatment site.  
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SIGNIFICANCE AND USE
4.1 Blood and blood components are irradiated to predetermined absorbed doses to inactivate viable lymphocytes to help prevent transfusion-induced graft-versus-host disease (GVHD) in certain immunocompromised patients and those receiving related-donor products (1, 2).9  
4.2 The assurance that blood and blood components have been properly irradiated is of crucial importance for patient health. This shall be demonstrated by means of accurate absorbed-dose measurements on the product, or in simulated product.  
4.3 Blood and blood components are usually irradiated using gamma radiation from 137Cs or 60Co sources, or X-radiation from X-ray units.  
4.4 Blood irradiation specifications include a lower limit of absorbed dose, and may include an upper limit or central target dose. For a given application, any of these values may be prescribed by regulations that have been established on the basis of available scientific data (see 2.6).  
4.5 For each blood irradiator, an absorbed-dose rate at a reference position within the canister is measured as part of irradiator acceptance testing using a reference-standard dosimetry system. That reference-standard measurement is used to establish operating parameters so as to deliver specified dose to blood and blood components.  
4.6 Absorbed-dose measurements are performed within the blood or blood-equivalent volume for determining the absorbed-dose distribution. Such measurements are often performed using simulated product (for example, polystyrene is considered blood equivalent for 137Cs photon energies).  
4.7 Dosimetry is part of a measurement management system that is applied to ensure that the radiation process meets predetermined specifications (see ISO/ASTM Practice 52628).  
4.8 Blood and blood components are usually irradiated in chilled or frozen condition. Care should be taken, therefore, to ensure that the dosimeters and radiation-sensitive indicators can be used under such temperature conditions.  
4.9 Proper ...
SCOPE
1.1 This practice outlines the irradiator installation qualification program and the dosimetric procedures to be followed during operational qualification and performance qualification of the irradiator. Procedures for the routine radiation processing of blood product (blood and blood components) are also given. If followed, these procedures will help ensure that blood product exposed to gamma radiation or X-radiation (bremsstrahlung) will receive absorbed doses with a specified range.  
1.2 This practice covers dosimetry for the irradiation of blood product for self-contained irradiators (free-standing irradiators) utilizing radionuclides such as 137Cs and  60Co, or X-radiation (bremsstrahlung). The absorbed dose range for blood irradiation is typically 15 Gy to 50 Gy.  
1.3 The photon energy range of X-radiation used for blood irradiation is typically from 40 keV to 300 keV.  
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SIGNIFICANCE AND USE
4.1 The primary use of these test methods is testing to determine the specified mechanical properties of steel, stainless steel, and related alloy products for the evaluation of conformance of such products to a material specification under the jurisdiction of ASTM Committee A01 and its subcommittees as designated by a purchaser in a purchase order or contract.  
4.1.1 These test methods may be and are used by other ASTM Committees and other standards writing bodies for the purpose of conformance testing.  
4.1.2 The material condition at the time of testing, sampling frequency, specimen location and orientation, reporting requirements, and other test parameters are contained in the pertinent material specification or in a general requirement specification for the particular product form.  
4.1.3 Some material specifications require the use of additional test methods not described herein; in such cases, the required test method is described in that material specification or by reference to another appropriate test method standard.  
4.2 These test methods are also suitable to be used for testing of steel, stainless steel and related alloy materials for other purposes, such as incoming material acceptance testing by the purchaser or evaluation of components after service exposure.  
4.2.1 As with any mechanical testing, deviations from either specification limits or expected as-manufactured properties can occur for valid reasons besides deficiency of the original as-fabricated product. These reasons include, but are not limited to: subsequent service degradation from environmental exposure (for example, temperature, corrosion); static or cyclic service stress effects, mechanically-induced damage, material inhomogeneity, anisotropic structure, natural aging of select alloys, further processing not included in the specification, sampling limitations, and measuring equipment calibration uncertainty. There is statistical variation in all aspects of mechanical testin...
SCOPE
1.1 These test methods2 cover procedures and definitions for the mechanical testing of steels, stainless steels, and related alloys. The various mechanical tests herein described are used to determine properties required in the product specifications. Variations in testing methods are to be avoided, and standard methods of testing are to be followed to obtain reproducible and comparable results. In those cases in which the testing requirements for certain products are unique or at variance with these general procedures, the product specification testing requirements shall control.  
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Bend  
15  
Hardness  
16  
Brinell  
17  
Rockwell  
18  
Portable  
19  
Impact  
20 to 30  
Keywords  
32  
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Annex A2  
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Annex A3  
Round Wire Products  
Annex A4  
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Annex A5  
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Annex A8  
Methods for Testing Steel Reinforcing Bars  
Annex A9  
Procedure for Use and Control of Heat-cycle Simulation  
Annex A10  
1.4 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.  
1.5 When these test methods are referenced in a metric product specification, the yield and tensile values may be determined in inch-pound (ksi) units then converted into SI (MPa) units. The elongation determined in inch-pound gauge lengths of 2 in. or 8 in. may be report...

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ASTM
ASTM F3565-23(Practice)
Standard Practice for Electrofusion Joining Polyethylene (PE) Pipe and Fittings for Pressure Pipe Service

SIGNIFICANCE AND USE
4.1 Using the procedures and apparatus in Sections 8 and 9 and the manufacturer's instructions, pressure-tight joints as strong as the pipe itself can be made between manufacturer-recommended combinations of pipe and fittings. See Specification F1055 for performance requirements of polyethylene electrofusion fittings.
SCOPE
1.1 This practice describes procedures for making joints suitable for pressure service with polyethylene (PE) pipe and fittings by means of electrofusion joining techniques in, but not limited to, a field environment. Other suitable electrofusion joining procedures are available from various sources including fitting manufacturers. This standard does not purport to address all possible electrofusion joining procedures, or to preclude the use of qualified procedures developed by other parties that have been proven to produce reliable electrofusion joints. (Note 1)
Note 1: Reference to the manufacturer in this practice refers to the electrofusion fitting manufacturer.  
1.2 The parameters and procedure are applicable only to joining polyethylene pipe and fittings (Note 2) which are intended for PE fuel gas pipe per Specification D2513 and PE potable water, sewer and industrial pipe manufactured per Specification F714, Specification D3035, Specification F2619, and AWWA C901 and C906.
Note 2: Commercially available materials classified with a thermoplastic pipe material designation code beginning with PE 14, PE 23, PE 24, PE 27, PE 33, PE 34, PE 36, and PE 46, and PE 47 in accordance with Specification D3350 and Terminology F412 are generally acceptable for electrofusion joining using this practice. Consult with the pipe or fitting manufacturer for specific compatibility information.  
1.3 Parts that are within the dimensional tolerances given in present ASTM specifications are required to produce sound joints between polyethylene pipe and fittings when using the joining techniques described in this practice.  
1.4 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.  
1.5 The text of this practice references notes, footnotes, and appendices which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the practice.  
1.6 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.  
1.7 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.

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ASTM
ASTM D5141-23(Test Method)
Standard Test Method for Determining Filtering Efficiency and Flow Rate of the Filtration Component of a Sediment Retention Device

SIGNIFICANCE AND USE
5.1 This test method is used to determine the filtering efficiency and flow rate of the filtration component of a sediment retention device, such as a silt fence, a silt barrier, or a silt curtain, for specific soil tested.  
5.2 This test method may be used for the design of the filtration component of a sediment retention device to meet requirements of regulatory agencies in filtering efficiency or flow rate for the specific soil tested.  
5.2.1 The designer can use this test method to determine the spacing between sediment retention devices.  
5.3 This test method is intended for performance evaluation, as the results will depend on the specific soil evaluated. Unless testing with the default soil is desired, it is recommended that the user or representative perform the test to pre-approve products, as sediment retention device manufacturers are not typically equipped to handle or test soil requirements.  
5.4 This test method provides a means of evaluating the filtration component of sediment retention devices with different soils under various conditions that simulate the conditions that exist in a sediment retention device installation. This test method may be used to simulate several storm events on the same sediment retention device specimen. Therefore, the number of times this test is repeated per specimen is dependent upon the user and the site conditions.
SCOPE
1.1 This test method is used to determine the filtering efficiency and the flow rate of the filtration component of a sediment retention device, such as a silt fence, silt barrier, or inlet protector.  
1.1.1 The results are shown as a percentage for filtering efficiency and cubic metres per square metre per minute (m3/m2/min) or gallons per square foot per minute (gal/ft2/min) for flow rate.  
1.1.2 The filtering efficiency indicates the percent of sediment removed from sediment-laden water.  
1.1.3 The flow rate is the average rate of passage of the sediment-laden water through the filtration component of a sediment retention device.  
1.2 This test method requires several specialized pieces of equipment, such as an integrated water sampler and an analytical balance, or a vacuum filtration system. At the client’s discretion, the test soil is either a site-specific soil or a soil that is representative of a target default gradation.  
1.3 The values stated in SI units are the standard, while the inch-pound units are provided for information. The values expressed in each system may not be exact equivalents; therefore, each system must be used independently of the other, without combining values in any way.  
1.4 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.  
1.5 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.

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