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ASTM F2079-09(2013)

(Test Method)

Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

SIGNIFICANCE AND USE
4.1 Minimal stent recoil is a desirable feature of a stent because it minimizes the maximum diameter to which a stent must be expanded to achieve its final relaxed diameter. A stent having a high recoil must be expanded to a greater diameter to achieve its final relaxed diameter than a stent having low recoil. Practically, excessive expansion of the vessel into which the stent is to be implanted may cause tissue damage resulting in a poor immediate result or poor long-term outcome. Stent recoil is affected by intrinsic properties of the material used to construct the stent and the specific geometric design of the stent; therefore, measuring stent recoil is an essential part of evaluating the design.
SCOPE
1.1 The purpose of this test method is to quantify the percentage by which the diameter of a stent decreases from its expanded diameter while still on the delivery balloon to its relaxed diameter after deflating the balloon. This test method is appropriate for stents manufactured from a material that is plastically deformed when the stent's diameter is increased from its predeployed size to its postdeployed size by mechanical means. This test method may be performed in air at room temperature unless there is a known temperature dependence of the material, in which case, the temperature at which the test is conducted shall be stated in the report.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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.

General Information

Status
Historical
Publication Date
28-Feb-2013
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

Relations

Replaces
ASTM F2079-09 - Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
Effective Date
01-Mar-2013
Referred By
ASTM F3036-21 - Standard Guide for Testing Absorbable Stents
Effective Date
01-Mar-2013
Referred By
ASTM F3067-14(2021) - Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
Effective Date
01-Mar-2013

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ASTM F2079-09(2013) - Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable StentsASTM F2079-09(2013) - Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
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ASTM F2079-09(2013) - Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2079 − 09 (Reapproved 2013)
Standard Test Method for
Measuring Intrinsic Elastic Recoil of Balloon-Expandable
Stents
This standard is issued under the fixed designation F2079; 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 The outer diameter of the stent is measured in at least three
axial locations while the stent is still on the inflated delivery
1.1 The purpose of this test method is to quantify the
balloon.At each axial location, measurements are taken in two
percentage by which the diameter of a stent decreases from its
approximately orthogonal rotational positions. The balloon is
expanded diameter while still on the delivery balloon to its
deflated and the outer diameter of the stent is remeasured in the
relaxed diameter after deflating the balloon.This test method is
same positions at approximately the same locations.
appropriate for stents manufactured from a material that is
plastically deformed when the stent’s diameter is increased
4. Significance and Use
from its predeployed size to its postdeployed size by mechani-
cal means. This test method may be performed in air at room
4.1 Minimal stent recoil is a desirable feature of a stent
temperatureunlessthereisaknowntemperaturedependenceof
because it minimizes the maximum diameter to which a stent
the material, in which case, the temperature at which the test is
must be expanded to achieve its final relaxed diameter.Astent
conducted shall be stated in the report.
having a high recoil must be expanded to a greater diameter to
achieve its final relaxed diameter than a stent having low
1.2 The values stated in SI units are to be regarded as
recoil. Practically, excessive expansion of the vessel into which
standard. No other units of measurement are included in this
the stent is to be implanted may cause tissue damage resulting
standard.
in a poor immediate result or poor long-term outcome. Stent
1.3 This standard does not purport to address all of the
recoil is affected by intrinsic properties of the material used to
safety concerns, if any, associated with its use. It is the
construct the stent and the specific geometric design of the
responsibility of the user of this standard to establish appro-
stent; therefore, measuring stent recoil is an essential part of
priate safety and health practices and determine the applica-
evaluating the design.
bility of regulatory limitations prior to use.
5. Apparatus
2. Terminology
5.1 Ameans to inflate with noncompressible fluid, typically
2.1 Definitions:
water, the delivery balloon on which the stent is mounted. The
2.1.1 labeled diameter, n—the nominal deployed size of a
means used must be capable of achieving the pressure required
stent as indicated on its manufacturer’s label.
to maintain the expanded diameter of the stent until it can be
2.1.2 stent recoil, n—the amount, expressed as a percentage,
measured and may include a device to monitor pressure.
by which the diameter of a stent changes from the expanded
diameter measured with the stent on the inflated delivery
5.2 A means to measure the outer diameter of the stent
balloon to the final value measured after deflating the balloon.
without deforming the stent. Typically, a calibrated optical
system, which does not require contact with the stent, is used.
3. Summary of Test Method
The resolution of the measurement system shall be 0.01 mm or
3.1 A sample device representative of product that will be better. The accuracy of the system shall be 2 % of reading or
marketed is either premounted or mounted on the delivery better.
balloon at the time of use. The delivery balloon is inflated to
the nominal expansion pressure indicated for the labeled stent. 6. Sampling, Test Specimens, and Test Units
6.1 Unless otherwise justified, all samples selected for
testing should be taken from fully processed, clinical quality
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
product. It is not required that these devices undergo terminal
F04.30 on Cardiovascular Standards.
sterilization.Cosmeticrejectsorothernonclinicalsamplesmay
Current edition approved March 1, 2013. Published March 2013. Originally
be used if the cause for rejection has been shown not to affect
approved in 2001. Last previous edition approved in 2009 as F2079 – 09. DOI:
10.1520/F2079-09R13. stent recoil.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2079 − 09 (2013)
6.2 The number of specimens tested for each unique stent the measurement system as in 7.4. These measurements should
geometry should be sufficient to meet sampling requirements be taken no sooner than 10 s after deflating the balloon.
for desired specification limits. In general, a minimum of ten
8. Calculation
specimens is recommended. If a single stent geometry is
8.1 Calculate the stent recoil for the locations measured in
intended to be used for more than one labeled diameter, recoil
7.4 for each stent using the following equation:
shall be evaluated for test specimens expanded to the smallest
and largest diameters intended for that geometry.
Diameter
final
Stent Recoil % 5 1 2 *100 (1)
~ ! S S DD
Diameter
6.3 Most stents are comprised of a repetitious continuous inflated
pattern or of repeating subunits. If stents are made longer by
where:
additional r
...

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Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

SIGNIFICANCE AND USE
4.1 Minimal stent recoil is a desirable feature of a stent because it minimizes the maximum diameter to which a stent must be expanded to achieve its final relaxed diameter. A stent having a high recoil must be expanded to a greater diameter to achieve its final relaxed diameter than a stent having low recoil. Practically, excessive expansion of the vessel into which the stent is to be implanted may cause tissue damage resulting in a poor immediate result or poor long-term outcome. Stent recoil is affected by intrinsic properties of the material used to construct the stent and the specific geometric design of the stent; therefore, measuring stent recoil is an essential part of evaluating the design.
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1.1 The purpose of this test method is to quantify the percentage by which the diameter of a stent decreases from its expanded diameter while still on the delivery balloon to its relaxed diameter after deflating the balloon. This test method is appropriate for stents manufactured from a material that is plastically deformed when the stent's diameter is increased from its predeployed size to its postdeployed size by mechanical means. This test method may be performed in air at room temperature unless there is a known temperature dependence of the material, in which case, the temperature at which the test is conducted shall be stated in the report.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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.

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SIGNIFICANCE AND USE
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.  
4.2 This guide is intended for use by researchers and manufacturers for the development and selection of pre-test treatments, tests, and test endpoints to measure stent securement (displacement distances and dislodgment forces).  
4.3 This guide may be used to investigate which practical combinations of in vitro tests best characterize clinical scenarios.  
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4.5 This guide may be of use for developing a test for meeting Parts 2 and 3 of the requirements of EN 14299, Section 7.3.4.4 on Trackability.  
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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 characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems.  
1.2 This guide covers the laboratory determination of the shear force required to displace or dislodge a balloon-expandable endovascular stent mounted on a delivery system. The guide proposes a set of options to consider when testing stent securement. The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. An example test apparatus is given in 7.1.  
1.3 This guide covers in vitro bench testing characterization only. Measured levels of securement and product design/process differentiation may be particularly influenced by selections of pre-test treatments, securement test type (for example, stent gripping method), and test endpoint. In vivo characteristics may also differ from in vitro results.  
1.4 This guide does not cover all possible pre-test treatments, stent securement tests, or test endpoints. It is intended to provide a starting point from which to select and investigate securement test options.  
1.5 This guide does not specify a method for mounting the stent onto the delivery system.  
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.  
1.7 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.  
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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.  
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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).  
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4.9 Proper ...
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Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

SIGNIFICANCE AND USE
4.1 Minimal stent recoil is a desirable feature of a stent because it minimizes the maximum diameter to which a stent must be expanded to achieve its final relaxed diameter. A stent having a high recoil must be expanded to a greater diameter to achieve its final relaxed diameter than a stent having low recoil. Practically, excessive expansion of the vessel into which the stent is to be implanted may cause tissue damage resulting in a poor immediate result or poor long-term outcome. Stent recoil is affected by intrinsic properties of the material used to construct the stent and the specific geometric design of the stent; therefore, measuring stent recoil is an essential part of evaluating the design.
SCOPE
1.1 The purpose of this test method is to quantify the percentage by which the diameter of a stent decreases from its expanded diameter while still on the delivery balloon to its relaxed diameter after deflating the balloon. This test method is appropriate for stents manufactured from a material that is plastically deformed when the stent's diameter is increased from its predeployed size to its postdeployed size by mechanical means. This test method may be performed in air at room temperature unless there is a known temperature dependence of the material, in which case, the temperature at which the test is conducted shall be stated in the report.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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.

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Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System

SIGNIFICANCE AND USE
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.  
4.2 This guide is intended for use by researchers and manufacturers for the development and selection of pre-test treatments, tests, and test endpoints to measure stent securement (displacement distances and dislodgment forces).  
4.3 This guide may be used to investigate which practical combinations of in vitro tests best characterize clinical scenarios.  
4.4 This guide should be used with discretion in choosing securement tests and evaluating results due to the myriad possible combinations of clinical conditions, failure modes, and stent delivery system designs.  
4.5 This guide may be of use for developing a test for meeting Parts 2 and 3 of the requirements of EN 14299, Section 7.3.4.4 on Trackability.  
4.6 This guide may be of use for developing a test to meet section VII-C-8 of CDRH Guidance document.
SCOPE
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 characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems.  
1.2 This guide covers the laboratory determination of the shear force required to displace or dislodge a balloon-expandable endovascular stent mounted on a delivery system. The guide proposes a set of options to consider when testing stent securement. The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. An example test apparatus is given in 7.1.  
1.3 This guide covers in vitro bench testing characterization only. Measured levels of securement and product design/process differentiation may be particularly influenced by selections of pre-test treatments, securement test type (for example, stent gripping method), and test endpoint. In vivo characteristics may also differ from in vitro results.  
1.4 This guide does not cover all possible pre-test treatments, stent securement tests, or test endpoints. It is intended to provide a starting point from which to select and investigate securement test options.  
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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.  
1.7 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.  
1.8 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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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.  
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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...

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ASTM
ASTM F2077-22(Test Method)
Standard Test Methods for Intervertebral Body Fusion Devices

SIGNIFICANCE AND USE
5.1 Intervertebral body fusion device assemblies are generally simple geometric-shaped devices which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment. This test method outlines materials and methods for the characterization and evaluation of the mechanical performance of different intervertebral body fusion device assemblies so that comparisons can be made between different designs.  
5.2 This test method is designed to quantify the static and dynamic characteristics of different designs of intervertebral body fusion device assemblies. These tests are conducted in vitro to allow for analysis and comparison of the mechanical performance of intervertebral body fusion device assemblies to specific force modalities.  
5.3 The forces applied to the intervertebral body fusion assemblies may differ from the complex loading seen in vivo, and therefore, the results from these tests may not directly predict in vivo performance. The results, however, can be used to compare mechanical performance of different intervertebral body fusion device assemblies.  
5.4 Since the environment may affect the dynamic performance of intervertebral body fusion device assemblies, dynamic testing in a saline environment may be considered. Fatigue tests should first be conducted in air (at ambient temperature) for comparison purposes since the environmental effects could be significant. If a simulated in vivo environment is desired, the investigator should consider testing in a saline environmental bath at 37 °C (for example, 0.9 g NaCl per 100 mL water) at a rate of 1 Hz or less. A simulated body fluid, a saline drip or mist, distilled water, or other type of lubrication at 37 °C could also be used with adequate justification.  
5.5 If the devices are known to be temperature and environment dependent, testing should be conducted in physiologic solution as described in 5.4. Devices that require...
SCOPE
1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.  
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.  
1.3 The test method describes static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies.  
1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.  
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).  
1.6 Guidelines are established for measuring displacements, determining the yield force or moment, and evaluating the stiffness and strength of the intervertebral body fusion device assemblies.  
1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.  
1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians.  
1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is ...

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  • Standard
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ASTM
ASTM A908-03(2019)(Specification)
Standard Specification for Stainless Steel Needle Tubing

ABSTRACT
The specification covers austenitic, stainless steel, needle tubing in hard-drawn tempers for industrial application. An electric furnace or other similar primary melting process with or without degassing or refining may be used. Needle tubing shall be made by the seamless or welded and drawn process and shall be furnished in the hard-drawn temper condition. Tension tests shall be made to meet the required tensile requirements.
SCOPE
1.1 This specification covers austenitic, stainless steel, needle tubing in hard-drawn tempers for industrial applications.  
1.2 In general, needle tubing describes small-diameter tubing with outside diameters (ODs) in the range of 0.008 to 0.203 in. (0.2 to 5.2 mm) with nominal wall thicknesses in the range of 0.002 to 0.015 in. (0.05 to 0.4 mm). Needle tubing gages are normally 6 through 33.  
1.3 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.  
1.4 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.

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