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ASTM F1441-03

(Specification)

Standard Specification for Soft-Tissue Expander Devices

Standard Specification for Soft-Tissue Expander Devices

ABSTRACT
This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed. This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification. The device shall be classified as: Type I; Type II; and Type III. Biocompatibility, tensile set, breaking force, tubing shell junction, injection port competence, overexpansion, tubing length adapter strength, needle stop penetration, and fused or adhered joints tests shall be performed to conform with the specified requirements.
SCOPE
1.1 This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed.
1.2 Limitations:
1.2.1 This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification.
1.2.2 This specification applies, in part, to combination "expander/mammary" devices as classified in Section 4.
1.3 The values stated in SI units are to be regarded as standard, values in parentheses are for information only.
1.4 The following statement pertains only to the test methods and requirements portion, Section 9, of this specification. 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
09-Apr-2003
ICS
85.100 - Equipment for the paper industry
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.32 - Plastic and Reconstructive Surgery
Current Stage
Ref Project

Relations

Replaces
ASTM F1441-92(2002) - Standard Specification for Soft-Tissue Expander Devices
Effective Date
10-Apr-2003
Replaced By
ASTM F1441-03(2009) - Standard Specification for Soft-Tissue Expander Devices
Effective Date
01-Apr-2009

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ASTM F1441-03 - Standard Specification for Soft-Tissue Expander Devices
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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: F 1441 – 03
Standard Specification for
1
Soft-Tissue Expander Devices
This standard is issued under the fixed designation F 1441; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope Used in Medical Applications Part I—Formulations and
3
Uncured Materials
1.1 This specification covers the requirements for single use
F 2042 Guide for Silicone Elastomers, Gels, and Foams
saline inflatable, smooth and textured tissue expansion devices
Used in Medical Application Part II—Crosslinking and
to be used intraoperatively or implanted for typically less than
3
Fabrication
6 months and then removed.
F 2051 Specification for Implantable Saline Filled Breast
1.2 Limitations:
3
Prosthesis
1.2.1 This specification applies only to soft-tissue expander
2.2 Other Documents:
devicesfabricatedwithelastomershells.Itdoesnotnecessarily
4
Federal Register, Title 21, Part 820
cover any custom fabricated soft tissue expander device
5
USP (United States Pharmacopoeia)
manufactured to any other specification.
Association for the Advance of Medical Instrumentation:
1.2.2 This specification applies, in part, to combination
ANSI/AAMI/ISO 10993-1, Biological Testing of Medical
“expander/mammary” devices as classified in Section 4.
and Dental Materials and Devices—Part 1: Guidance on
1.3 The values stated in SI units are to be regarded as
6
Selection of Tests
standard, values in parentheses are for information only.
ANSI/AAMI/ST50-1995, Dry Heat (Heated Air) Steriliz-
1.4 The following statement pertains only to the test meth-
6
ers
ods and requirements portion, Section 9, of this specification.
ANSI/AAMI/ISO 11135-1994, Medical Devices—
This standard does not purport to address all of the safety
Validation and Routine Control of Ethylene Oxide Steril-
concerns, if any, associated with its use. It is the responsibility
6
ization
of the user of this standard to establish appropriate safety and
ANSI/AAMI/ISO 11137-1994, Sterilization of Health Care
health practices and determine the applicability of regulatory
Products—Requirements for Validation and Routine and
limitations prior to use.
6
Routine Control—Radiation Sterilization
2. Referenced Documents ANSI/AAMI/ISO 11134-1993, Sterilization of Health Care
Products—Requirements for Validation and Routine
2.1 ASTM Standards:
6
Control—Industrial Moist Heat Sterilization
D 412 Test Methods for Vulcanized Rubber and Thermo-
2
Parenteral Drug Association, 1981 Technical Report No. 3,
plastic Elastomers—Tension
Validation of Dry Heat Processes Used for Sterilization
D 624 Test Method for Tear Strength of Conventional
7
2
and Depyrogenation
Vulcanized Rubber and Thermoplastic Elastomers
D 1349 Practice for Rubber—Standard Temperatures for
3. Terminology
2
Testing
3
3.1 Definitions:
F 703 Specification for Implantable Breast Prostheses
3.1.1 injection port—the port through which an injection to
F 748 Practice for Selecting Generic Biological Test Meth-
3
inflate or deflate the variable volume device is made.
ods for Materials and Devices
3.1.1.1 remote port—aportthatisremotefromtheshelland
F 1251 Terminology Relating to Polymeric Biomaterials in
3
attached to the shell by means of tubing.
Medical and Surgical Devices
F 2038 Guide for Silicone Elastomers, Gels and Foams
4
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
1 5
This specification is under the jurisdiction of ASTM Committee F04 on United States Pharmacopeia, Vol XXI, Mack Publishing Company, Easton, PA
Medical and Surgical Materials and Devices and is the direct responsibility of 1989. Available from Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway,
Subcommittee F04.32 on Plastic and Reconstructive Surgery. Rockville, NC 00852.
6
Current edition approved Apr. 10, 2003. Published May 2003. Originally Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
approved in 1992. Last previous edition approved in 2002 as F 1441 – 92 (2002). 4th Floor, New York, NY 10036.
2 7
Annual Book of ASTM Standards, Vol 09.01. Available from the Parenteral Drug Association, 3 Bethesda Medical Center,
3
Annual Book of ASTM Standards, Vol 13.01. Suite 1500, Bethesda, MD 20814.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F1441–03
3.1.1.2 self-contained (integrated) port—a port that is inte- reasonable safety and efficacy as it relates to the biocompat-
gral to the device shell. ibility and the mechanical integrit
...

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ASTM F1441-03(2022)(Specification)
Standard Specification for Soft-Tissue Expander Devices

ABSTRACT
This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed. This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification. The device shall be classified as: Type I; Type II; and Type III. Biocompatibility, tensile set, breaking force, tubing shell junction, injection port competence, overexpansion, tubing length adapter strength, needle stop penetration, and fused or adhered joints tests shall be performed to conform with the specified requirements.
SIGNIFICANCE AND USE
5.1 This specification contains requirements based on state-of-the-art science and technology as applicable to various considerations that have been identified as important to ensure reasonable safety and efficacy as it relates to the biocompatibility and the mechanical integrity of the device components in soft-tissue expander devices.  
5.1.1 This specification is not intended to limit the science and technology that may be considered and applied to ensure performance characteristics of subject devices in intended applications. When new information becomes available or changes in state-of-the-art science and technology occur and relevance to subject devices has been established by valid science, it is intended that this specification will be revised in accordance with ASTM guidelines.
SCOPE
1.1 This specification covers the requirements for single-use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than six months and then removed.  
1.2 Limitations:  
1.2.1 This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification.  
1.2.2 This specification applies in part to combination “expander/mammary” devices as classified in Section 4.  
1.3 The values stated in SI units are to be regarded as standard; values in parentheses are for information only.  
1.4 The following statement pertains only to the test methods and requirements portion, Section 9, of this specification: 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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ASTM F1441-03(2022)(Specification)
Standard Specification for Soft-Tissue Expander Devices

ABSTRACT
This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed. This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification. The device shall be classified as: Type I; Type II; and Type III. Biocompatibility, tensile set, breaking force, tubing shell junction, injection port competence, overexpansion, tubing length adapter strength, needle stop penetration, and fused or adhered joints tests shall be performed to conform with the specified requirements.
SIGNIFICANCE AND USE
5.1 This specification contains requirements based on state-of-the-art science and technology as applicable to various considerations that have been identified as important to ensure reasonable safety and efficacy as it relates to the biocompatibility and the mechanical integrity of the device components in soft-tissue expander devices.  
5.1.1 This specification is not intended to limit the science and technology that may be considered and applied to ensure performance characteristics of subject devices in intended applications. When new information becomes available or changes in state-of-the-art science and technology occur and relevance to subject devices has been established by valid science, it is intended that this specification will be revised in accordance with ASTM guidelines.
SCOPE
1.1 This specification covers the requirements for single-use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than six months and then removed.  
1.2 Limitations:  
1.2.1 This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification.  
1.2.2 This specification applies in part to combination “expander/mammary” devices as classified in Section 4.  
1.3 The values stated in SI units are to be regarded as standard; values in parentheses are for information only.  
1.4 The following statement pertains only to the test methods and requirements portion, Section 9, of this specification: 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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ASTM E2598/E2598M-21(Practice)
Standard Practice for Acoustic Emission Examination of Cast Iron Yankee and Steam Heated Paper Dryers

SIGNIFICANCE AND USE
5.1 Cast iron Yankee dryers can be up to 6.7 m [22 ft] in diameter, 7.3 m [24 ft] long, and weigh 91 000 Kg [100 tons], or more (refer to Fig. 1). Vessel thickness measurements are available from the paper/tissue machine operator. Cast iron is a brittle metal and has no specific yield point. Yankee dryers must maintain specific dimensional tolerances. When a pressurized Yankee or steam heated paper dryer (SHPD) remains stationary, it fills with condensate at a rapid rate. In an hour, a steam pressurized Yankee or SHPD can fill half way with condensate, doubling the weight on the frame, and the floor. Some Yankee owners have corporate requirements that a cast iron Yankee dryer remain stationary for 1/2 h, then rotation is required. Permission is required, if the Yankee is to remain stationary for more time. This issue should be discussed with the responsible person prior to the examination.
FIG. 1 Yankee Dryer Drum  
5.2 Yankee dryers operate under a heated hood. The hood is in close proximity to the Yankee shell and allows only inches of clearance for the top half of the vessel.  
5.3 Cast iron steam heated paper machine dryers are 2 m [6 ft] in diameter, or more, and may be 9 m [30 ft] long.  
5.4 Grey cast iron experiences a continuing reduction in elastic modulus as it is stressed to increasing higher levels. It is prudent not to stress grey cast iron material beyond its operating stress level.  
5.5 Flaws to be found are the same as those in any cast and machined product. Attempts have been made to characterize strength properties of cast irons in compact tension tests. In a TAPPI sponsored laboratory study, two out of three cast iron compact tension specimens experienced unplanned failures. From that experience it was cautioned that cracks initiated and grew faster than expected resulting in brittle fracture before the process could be halted. The failure of these two coupons demonstrated the rate in which cracks can grow in these materials and the mater...
SCOPE
1.1 This practice is no longer being updated but is being retained for historical value due to the procedures herein that are unique to the AE community.  
1.2 This practice provides guidelines for carrying out acoustic emission (AE) examinations of Yankee and Steam Heated Paper Dryers (SHPD) of the type to make tissue, paper, and paperboard products.  
1.3 This practice requires pressurization to levels used during normal operation. The pressurization medium may be high temperature steam, air, or gas. The dryer is also subjected to significant stresses during the heating up and cooling down periods of operation. Acoustic Emission data maybe collected during these time periods but this testing is beyond the scope of this document.  
1.4 The AE measurements are used to detect, as well as, localize emission sources. Other methods of nondestructive testing (NDT) may be used to further evaluate the significance of acoustic emission sources.  
1.5 Units—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 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 D2176-16(2021)(Test Method)
Standard Test Method for Folding Endurance of Paper and Plastics Film by the M.I.T. Tester

SIGNIFICANCE AND USE
4.1 The folding endurance is frequently used to estimate the ability of the paper and plastics film to withstand repeated bending, folding, and creasing.  
4.2 Folding endurance has also been found useful in measuring the deterioration of paper and plastics film upon aging.
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1.1 This test method describes the use of the M.I.T.-type folding apparatus for determining folding endurance of paper and plastics film. The M.I.T. tester can be adjusted for samples of any thickness; however, if the outer layers thicker than about 0.25 mm (0.01 in.) rupture during the first few folds, the test loses its significance. The procedure for the Schopper-type apparatus is given in Test Method D643.  
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ASTM E2907/E2907M-13(2019)(Practice)
Standard Practice for Examination of Paper Machine Rolls Using Acoustic Emission from Crack Face Rubbing

SIGNIFICANCE AND USE
5.1 Paper machine rolls can range in size from 2.4 to 9 m [8 to 30 ft] long, with a shell thickness of from 12.5 to 75 mm [0.5 to 3 in.,] and 300 to 1200 mm [12 to 48 in.] diameter. Depending on purpose, paper machine rolls can weigh as little as 60 000 kg [13 000 lb] to as much as 27 500 kg [60 000 lb].  
5.2 If indications are found during this procedure it can be repeated, with additional sensors to refine source location accuracy.  
5.3 Removal of rolls for traditional NDT examination may be impractical and may not be sensitive enough to locate small defects.  
5.4 Traditional AE examination, whereby the roll is subjected to load greater than service load to detect crack extension, risks damage to the roll and is best employed as a follow-up NDT examination.  
5.5 Manual rotation through a full revolution subjects existing cracks to tensile and compressive forces which can open and close existing cracks, and cause friction at the crack surfaces.  
5.6 Excess background noise (overhead cranes, nearby maintenance activities) may distort AE data or render it useless. Users must be aware of the following common sources of background noise: bearing noise (lack of lubrication, spalling, and so forth), mechanical contact with the roll by other objects, electromagnetic interference (EMI) and radio frequency interference (RFI) from nearby broadcasting facilities and from other sources. This practice should not be used if background noise cannot be eliminated or controlled.  
5.7 Other Non-destructive test methods may be used to evaluate the significance of AE indications. Traditional AE has been used to confirm the existence of the AE indication and fine tune the location. Magnetic particle, ultrasonic and radiographic examinations have been used to establish the position, depth and dimensions of the indication. Procedures for using other NDT methods are beyond the scope of this practice.
SCOPE
1.1 This practice provides guidelines for acoustic emission (AE) examinations of non-pressure, paper machine rolls.  
1.2 This practice utilizes a slow rotation of the roll to produce a full load cycle where load is provided by the weight of the roll suspended from its bearings or other journal support mechanism(s).  
1.3 This practice is used for detection of cracks and other discontinuities in rolls that produce frictional acoustic emission during rotation.  
1.4 The AE measurements are used to detect or locate emission sources, or both. Other nondestructive test (NDT) methods must be used to evaluate the significance of AE sources. Procedures for other NDT techniques are beyond the scope of this practice. See Note 1.
Note 1: Traditional AE examination, magnetic particle examination, shear wave ultrasonic examination, and radiography are commonly used to establish the exact position and dimensions of flaws that produce AE.  
1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
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. Specific precautionary statements are given in Section 8.  
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Standard Guide for Ecological Considerations for the Use of Oil Spill Dispersants in Freshwater and Other Inland Environments, Lakes and Large Water Bodies

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3.1 This guide is meant to aid response teams who may use it during spill response planning and spill events.  
3.2 This guide should be adapted to site specific circumstance.
SCOPE
1.1 This guide covers the use of oil spill dispersants to assist in the control of oil spills. The guide is written with the goal of minimizing the environmental impacts of oil spills; this goal is the basis on which the recommendations are made. Aesthetic and socioeconomic factors are not considered, although these and other factors are often important in spill response.  
1.2 Spill responders have available several means to control or clean up spilled oil. Chemical dispersants should be given equal consideration with other spill countermeasures.  
1.3 This is a general guide only. Oil, as used in this guide, includes crude oils and refined petroleum products. Differences between individual dispersants or between different oil products are not considered. The dispersibility of the oil with the chosen dispersant should be evaluated.  
1.4 The guide is organized by habitat type, for example, small ponds and lakes, rivers and streams, and land. It considers the use of dispersants primarily to protect habitats from impact (or to minimize impacts).  
1.5 This guide applies only to freshwater and other inland environments. It does not consider the direct application of dispersants to subsurface waters.  
1.6 In making dispersant use decisions, appropriate government authorities should be consulted as required by law.  
1.7 This guide does not address getting regulatory approval.  
1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.9 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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Standard Test Method for Drying Shrinkage of Mortar Containing Hydraulic Cement

SIGNIFICANCE AND USE
4.1 This test method establishes a selected set of conditions of temperature, relative humidity and rate of evaporation of the environment to which a mortar specimen of stated composition shall be subjected for a specified period of time during which its change in length is determined and designated “drying shrinkage.”  
4.2 The drying shrinkage of mortar as determined by this test method has a linear relation to the drying shrinkage of concrete made with the same cement and exposed to the same drying conditions.4 Hence this test method may be used when it is desired to develop data on the effect of a hydraulic cement on the drying shrinkage of concrete made with that cement.
SCOPE
1.1 This test method determines the change in length on drying of mortar bars containing hydraulic cement and graded standard sand.  
1.2 The values stated in SI units are to be regarded as standard. When combined standards are referenced, the selection of measurement system is at the user’s discretion subject to the requirements of the referenced 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. Warning—Fresh hydraulic cementitious mixtures are caustic and may cause chemical burns to skin and tissue upon prolonged exposure).2  
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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ASTM D1751-23(Specification)
Standard Specification for Preformed Expansion Joint Filler for Concrete Paving and Structural Construction (Nonextruding and Resilient Asphalt Types)

SCOPE
1.1 This specification covers preformed expansion joint filler having relatively little extrusion and substantial recovery after release from compression.  
1.2 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.  
Note 1: Attention is called to Specifications D1752 and D994/D994M.  
1.3 The text of this standard references notes and footnotes which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the 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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ASTM B637-23(Specification)
Standard Specification for Precipitation-Hardening and Cold Worked Nickel Alloy Bars, Forgings, and Forging Stock for Moderate or High Temperature Service

ABSTRACT
This specification covers hot- and cold-worked precipitation-hardenable nickel alloy rod, bar, forgings, and forging stock for high-temperature service. Chemical analysis shall be performed on the alloy and shall conform to the chemical composition requirement in carbon, manganese, silicon, phosphorus, sulfur, chromium, cobalt, molybdenum, columbium, tantalum, titanium, aluminum, zirconium, boron, iron, copper, and nickel. The material shall follow recommended annealing treatment, solution treatment, stabilizing treatment, and precipitation hardening treatment. Tension testing, hardness testing and stress-rupture testing shall be performed on the material and shall comply to the required tensile strength, yield strength, elongation, reduction in area, and Brinell hardness.
SCOPE
1.1 This specification2 covers hot- and cold-worked precipitation-hardenable nickel alloy rod, bar, forgings, and forging stock for moderate or high temperature service (Table 1).  
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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 become familiar with all hazards including those identified in the appropriate Safety Data Sheet (SDS) for this product/material as provided by the manufacturer, 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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ASTM D8139-23(Specification)
Standard Specification for Semi-Rigid, Closed-Cell Polypropylene Foam, Preformed Expansion Joint Fillers for Concrete Paving and Structural Construction

SCOPE
1.1 This specification covers preformed expansion joint fillers made from closed-cell polypropylene foam materials having suitable compressibility, recovery from compression, nonextruding, and weather-resistant characteristics.  
1.1.1 Type I, closed-cell polypropylene foam.  
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1.3 The values stated in inch-pound units are to be regarded as the standard.  
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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