iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM E2998-16

(Practice)

Standard Practice for Characterization and Classification of Smokeless Powder

Standard Practice for Characterization and Classification of Smokeless Powder

SIGNIFICANCE AND USE
5.1 This practice establishes guidelines for the characterization of smokeless powder which can be used as an explosive for improvised explosive devices or as a propellant, such as for small arms ammunition and for military ordnance.  
5.2 This practice establishes the minimum criteria necessary to classify smokeless powders.  
5.3 The morphology of smokeless powder is a distinct characteristic used for classification and identification purposes.  
5.4 The identification of a questioned sample as smokeless powder (that is, it is a propellant or low explosive) does not require the identification of chemical components of a smokeless powder other than nitrocellulose.  
5.5 Identification of organic compounds associated with smokeless powders is a requirement to classify a smokeless powder sample as single-base, double-base, or triple-base.  
5.6 Additional analytical techniques may be available that are not mentioned within this document that are acceptable for the characterization and analysis of smokeless powders.  
5.7 The requirements to associate a questioned smokeless powder to a unique smokeless powder product by brand name or intercomparison of two or more questioned powders are beyond the scope of this document (13-15).  
5.8 The identification of smokeless powder residue in the absence of whole or partial grains is beyond the scope of this document.
SCOPE
1.1 This practice describes procedures for characterization and analysis of smokeless powders recovered from explosives incidents (1, 2),2 materials or objects containing gunshot residue (3) when visible grains are present, or bulk samples of powder.  
1.2 Smokeless powder is characterized by shape, color, texture, manufacturing toolmarks, markers, dimensional measurements, and chemical composition (4-6).  
1.3 Smokeless powder is an energetic material classified as a low explosive or propellant. Smokeless powder can be further classified as single-base, double-base, or triple-base.  
1.4 Analysis of post-blast debris and items containing gunshot residue when visible grains of smokeless powder are not present is beyond the scope of this practice.  
1.5 This practice will provide guidelines for the analysis of organic components of smokeless powders using various instrumental techniques, such as gas chromatography-mass spectrometry, liquid chromatography, and Fourier transform infrared spectroscopy.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 This standard involves handling of low explosives and potentially other energetic materials. It is strongly suggested that an analyst be trained in the storage and safe handling of energetic materials and be familiar with the properties and hazards of explosives.  
1.8 This standard cannot replace knowledge, skill, or ability acquired through appropriate education, training, and experience and should be used in conjunction with sound professional judgment.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Published
Publication Date
30-Sep-2016
ICS
71.100.30 - Explosives. Pyrotechnics and fireworks
Technical Committee
E30 - Forensic Sciences
Drafting Committee
E30.01 - Criminalistics
Current Stage
Ref Project

Relations

Refers
ASTM E1618-14 - Standard Test Method for Ignitable Liquid Residues in Extracts from Fire Debris Samples by Gas Chromatography-Mass Spectrometry
Effective Date
01-Jul-2014

Buy Standard

ASTM E2998-16 - Standard Practice for Characterization and Classification of Smokeless PowderASTM E2998-16 - Standard Practice for Characterization and Classification of Smokeless Powder
PreviousNext
Standard
ASTM E2998-16 - Standard Practice for Characterization and Classification of Smokeless Powder
English language
7 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

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:E2998 −16 An American National Standard
Standard Practice for
1
Characterization and Classification of Smokeless Powder
This standard is issued under the fixed designation E2998; 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 priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1.1 This practice describes procedures for characterization
and analysis of smokeless powders recovered from explosives
2 2. Referenced Documents
incidents (1, 2), materials or objects containing gunshot
3
residue (3) when visible grains are present, or bulk samples of 2.1 ASTM Standards:
powder. E620 Practice for Reporting Opinions of Scientific or Tech-
nical Experts
1.2 Smokeless powder is characterized by shape, color,
E1492 Practice for Receiving, Documenting, Storing, and
texture, manufacturing toolmarks, markers, dimensional
Retrieving Evidence in a Forensic Science Laboratory
measurements, and chemical composition (4-6).
E1618 TestMethodforIgnitableLiquidResiduesinExtracts
1.3 Smokeless powder is an energetic material classified as
from Fire Debris Samples by Gas Chromatography-Mass
a low explosive or propellant. Smokeless powder can be
Spectrometry
further classified as single-base, double-base, or triple-base.
3. Terminology
1.4 Analysis of post-blast debris and items containing gun-
shot residue when visible grains of smokeless powder are not
3.1 Definitions of Terms Specific to This Standard:
present is beyond the scope of this practice.
3.1.1 ball powders, n—a class of smokeless powders pro-
1.5 This practice will provide guidelines for the analysis of duced by a process where the final grain morphologies are
spherical, flattened-ball, or flake.
organic components of smokeless powders using various
instrumental techniques, such as gas chromatography-mass
3.1.2 double-base, n—propellant containing nitrocellulose
spectrometry, liquid chromatography, and Fourier transform
and nitroglycerin.
infrared spectroscopy.
3.1.3 deterrent, n—a compound to slow the burning rate of
1.6 The values stated in SI units are to be regarded as
a powder.
standard. No other units of measurement are included in this
3.1.4 energetic, n—an explosive compound used to enhance
standard.
the burning rate of a powder.
1.7 This standard involves handling of low explosives and
3.1.5 extruded powders, n—a class of smokeless powders
potentially other energetic materials. It is strongly suggested
produced by an extrusion process where the final grain
that an analyst be trained in the storage and safe handling of
morphologies are disc or cylinder.
energetic materials and be familiar with the properties and
3.1.6 grain, n—an individual particle of smokeless powder.
hazards of explosives.
3.1.7 marker, n—a colored grain of smokeless powder to
1.8 This standard cannot replace knowledge, skill, or ability
assist in the visual identification of a bulk reloading smokeless
acquired through appropriate education, training, and experi-
powder.
ence and should be used in conjunction with sound profes-
sional judgment.
3.1.8 perforation, n—aholeinadiscpowderoroneormore
1.9 This standard does not purport to address all of the
holes running through the length of a cylinder powder created
safety concerns, if any, associated with its use. It is the
during the manufacturing process in extruded powders.
responsibility of the user of this standard to establish appro-
3.1.9 single-base, n—propellant containing nitrocellulose as
the major energetic material.
1
This practice is under the jurisdiction of ASTM Committee E30 on Forensic
Sciences and is the direct responsibility of Subcommittee E30.01 on Criminalistics.
3
Current edition approved Oct. 1, 2016. Published October 2016. DOI: 10.1520/ For referenced ASTM standards, visit the ASTM website, www.astm.org, or
E2998-16. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
The boldface numbers in parentheses refer to a list of references at the end of Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2998−16
3.1.10 smokeless powder, n—apropellantandlowexplosive 6. Apparatus
composed of nitrocellulose and other organic and inorganic
6.1 Ste
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ASTM
ASTM E3329-21e1(Practice)
Standard Practice for Establishing an Examination Scheme for Explosive Residues

SIGNIFICANCE AND USE
6.1 This practice is designed to assist the forensic explosives examiner in selecting and organizing an analytical scheme for identifying explosive residues. The amount and condition of the sample, as well as the availability of instrumental techniques, will determine the selected analytical scheme.  
6.2 The forensic explosives examiner considers relevant issues about the case investigation and submitted items, such as sample size, complexity and condition, environmental effects, and collection methods used. Considerations include test methods, sample preparation schemes, test sequences, and acceptable degrees of sample alteration and consumption that will be different for each case submission.  
6.3 This practice is used when insufficient material is present to follow Practice E3253.  
6.4 This practice is used in conjunction with the referenced documents.  
6.5 This practice does not attempt to address all the issues regarding sample analyses. There could be additional tests or analyses performed to provide further discrimination and characterization of samples.
SCOPE
1.1 This practice covers the evaluation, selection, and application of techniques to establish an examination scheme for use by forensic explosives examiners to identify residues from low and high explosives. A foundation for the consistent approach to the analysis of visible and non-visible explosive residues from post-blast or other explosive-related scenes is provided. Methods for the development of identifying information that follows an efficient order of testing are described.  
1.2 This practice establishes requirements for the use of visual, physical, analytical, and instrumental techniques that provide structural and chemical information for an identification of an explosive residue.  
1.3 Techniques used in the examination of explosive residues include visual and microscopical inspection, physical characterization, ignition susceptibility testing, chemical and spot testing, and instrumental methods.  
1.4 This standard is intended for use by competent forensic science practitioners with the requisite formal education, discipline-specific training (see Practice E2917), and demonstrated proficiency to perform forensic casework (refer to the T/SWGFEX Suggested Guide for Explosives Analysis Training).  
1.5 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.  
1.6 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.

  • Standard
    6 pages
    English language
    sale 15% off
ASTM
ASTM E3253-21(Practice)
Standard Practice for Establishing an Examination Scheme for Intact Explosives

SIGNIFICANCE AND USE
5.1 This practice is designed to assist the forensic explosives examiner in selecting and organizing an analytical scheme for identifying intact explosives. The amount and condition of the sample, as well as the availability of applicable instrumental techniques, will determine the selected analytical scheme.  
5.2 The forensic explosives examiner considers relevant issues about the case investigation and submitted items, such as sample size, complexity and condition, environmental effects, and collection methods used. Considerations include test methods, sample preparation schemes, test sequences, and acceptable degrees of sample alteration and consumption that will be different for each case submission.  
5.3 This practice provides the minimum criteria for identifying explosive material. The examiner determines an analytical scheme that uses techniques to correctly identify the material, which could include oxidizers, fuels, binders, and detection agents.  
5.4 This practice is used in conjunction with the referenced documents.  
5.5 This practice does not attempt to address all the issues regarding sample analyses. There could be additional tests or analyses performed to provide further discrimination and characterization of samples.
SCOPE
1.1 This practice covers the evaluation, selection, and application of techniques to establish examination schemes for use by forensic explosives examiners to identify intact (unexploded) low and high explosives. A foundation for a consistent approach to the analysis of intact explosives is provided. Methods for the development of identifying information that follows an efficient order of testing are described.  
1.2 This practice establishes requirements for the use of visual, physical, analytical, and instrumental techniques that provide structural and chemical information for an identification of a high or low explosive material.  
1.3 Techniques used in the examination of explosives include visual and microscopical inspection, physical characterization, ignition susceptibility testing, chemical and spot testing, and instrumental methods.  
1.4 The minimum requirements for identification of commonly encountered explosives and explosive materials are listed.  
1.5 This standard is intended for use by competent forensic science practitioners with the requisite formal education, discipline-specific training (see Practice E2917), and demonstrated proficiency to perform forensic casework (refer to the T/SWGFEX Suggested Guide for Explosives Analysis Training).  
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.

  • Standard
    9 pages
    English language
    sale 15% off
ASTM
ASTM E3196-21(Terminology)
Standard Terminology Relating to the Examination of Explosives

SIGNIFICANCE AND USE
3.1 These terms have particular application to explosives analysis. In addition, several sources of definitions were used in the development of this terminology: Hawley’s Condensed Chemical Dictionary, Sixteenth Edition  (1);3  Practical Bomb Scene Investigation, Third Edition  (2); Forensic Investigation of Explosions  (3); Chemistry of Pyrotechnics, Third Edition  (4); Explosives, Seventh Completely Revised and Updated Edition  (5); Dictionary of Explosions & Explosives  (6); PICATINNY Encyclopedia of Explosives and Related Items  (7, 8); Merriam-Webster.com Dictionary  (9); and DOD Dictionary of Military and Associated Terms  (10). A suitable definition was developed after all of the sources were found wanting.
SCOPE
1.1 This is a compilation of terms and corresponding definitions related to the analysis of explosives. Legal or scientific terms that are generally understood or defined adequately in other readily available sources may not be included.  
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 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.

  • Standard
    5 pages
    English language
    sale 15% off
ASTM
ASTM E3329-21e1(Practice)
Standard Practice for Establishing an Examination Scheme for Explosive Residues

SIGNIFICANCE AND USE
6.1 This practice is designed to assist the forensic explosives examiner in selecting and organizing an analytical scheme for identifying explosive residues. The amount and condition of the sample, as well as the availability of instrumental techniques, will determine the selected analytical scheme.  
6.2 The forensic explosives examiner considers relevant issues about the case investigation and submitted items, such as sample size, complexity and condition, environmental effects, and collection methods used. Considerations include test methods, sample preparation schemes, test sequences, and acceptable degrees of sample alteration and consumption that will be different for each case submission.  
6.3 This practice is used when insufficient material is present to follow Practice E3253.  
6.4 This practice is used in conjunction with the referenced documents.  
6.5 This practice does not attempt to address all the issues regarding sample analyses. There could be additional tests or analyses performed to provide further discrimination and characterization of samples.
SCOPE
1.1 This practice covers the evaluation, selection, and application of techniques to establish an examination scheme for use by forensic explosives examiners to identify residues from low and high explosives. A foundation for the consistent approach to the analysis of visible and non-visible explosive residues from post-blast or other explosive-related scenes is provided. Methods for the development of identifying information that follows an efficient order of testing are described.  
1.2 This practice establishes requirements for the use of visual, physical, analytical, and instrumental techniques that provide structural and chemical information for an identification of an explosive residue.  
1.3 Techniques used in the examination of explosive residues include visual and microscopical inspection, physical characterization, ignition susceptibility testing, chemical and spot testing, and instrumental methods.  
1.4 This standard is intended for use by competent forensic science practitioners with the requisite formal education, discipline-specific training (see Practice E2917), and demonstrated proficiency to perform forensic casework (refer to the T/SWGFEX Suggested Guide for Explosives Analysis Training).  
1.5 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.  
1.6 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.

  • Standard
    6 pages
    English language
    sale 15% off
ASTM
ASTM E3253-21(Practice)
Standard Practice for Establishing an Examination Scheme for Intact Explosives

SIGNIFICANCE AND USE
5.1 This practice is designed to assist the forensic explosives examiner in selecting and organizing an analytical scheme for identifying intact explosives. The amount and condition of the sample, as well as the availability of applicable instrumental techniques, will determine the selected analytical scheme.  
5.2 The forensic explosives examiner considers relevant issues about the case investigation and submitted items, such as sample size, complexity and condition, environmental effects, and collection methods used. Considerations include test methods, sample preparation schemes, test sequences, and acceptable degrees of sample alteration and consumption that will be different for each case submission.  
5.3 This practice provides the minimum criteria for identifying explosive material. The examiner determines an analytical scheme that uses techniques to correctly identify the material, which could include oxidizers, fuels, binders, and detection agents.  
5.4 This practice is used in conjunction with the referenced documents.  
5.5 This practice does not attempt to address all the issues regarding sample analyses. There could be additional tests or analyses performed to provide further discrimination and characterization of samples.
SCOPE
1.1 This practice covers the evaluation, selection, and application of techniques to establish examination schemes for use by forensic explosives examiners to identify intact (unexploded) low and high explosives. A foundation for a consistent approach to the analysis of intact explosives is provided. Methods for the development of identifying information that follows an efficient order of testing are described.  
1.2 This practice establishes requirements for the use of visual, physical, analytical, and instrumental techniques that provide structural and chemical information for an identification of a high or low explosive material.  
1.3 Techniques used in the examination of explosives include visual and microscopical inspection, physical characterization, ignition susceptibility testing, chemical and spot testing, and instrumental methods.  
1.4 The minimum requirements for identification of commonly encountered explosives and explosive materials are listed.  
1.5 This standard is intended for use by competent forensic science practitioners with the requisite formal education, discipline-specific training (see Practice E2917), and demonstrated proficiency to perform forensic casework (refer to the T/SWGFEX Suggested Guide for Explosives Analysis Training).  
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.

  • Standard
    9 pages
    English language
    sale 15% off
ASTM
ASTM E3196-21(Terminology)
Standard Terminology Relating to the Examination of Explosives

SIGNIFICANCE AND USE
3.1 These terms have particular application to explosives analysis. In addition, several sources of definitions were used in the development of this terminology: Hawley’s Condensed Chemical Dictionary, Sixteenth Edition  (1);3  Practical Bomb Scene Investigation, Third Edition  (2); Forensic Investigation of Explosions  (3); Chemistry of Pyrotechnics, Third Edition  (4); Explosives, Seventh Completely Revised and Updated Edition  (5); Dictionary of Explosions & Explosives  (6); PICATINNY Encyclopedia of Explosives and Related Items  (7, 8); Merriam-Webster.com Dictionary  (9); and DOD Dictionary of Military and Associated Terms  (10). A suitable definition was developed after all of the sources were found wanting.
SCOPE
1.1 This is a compilation of terms and corresponding definitions related to the analysis of explosives. Legal or scientific terms that are generally understood or defined adequately in other readily available sources may not be included.  
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 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.

  • Standard
    5 pages
    English language
    sale 15% off
ASTM
ASTM A370-23(Test Method)
Standard Test Methods and Definitions for Mechanical Testing of Steel Products

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.  
1.2 The following mechanical tests are described:    
Sections  
Tension  
7 to 14  
Bend  
15  
Hardness  
16  
Brinell  
17  
Rockwell  
18  
Portable  
19  
Impact  
20 to 30  
Keywords  
32  
1.3 Annexes covering details peculiar to certain products are appended to these test methods as follows:    
Annex  
Bar Products  
Annex A1  
Tubular Products  
Annex A2  
Fasteners  
Annex A3  
Round Wire Products  
Annex A4  
Significance of Notched-Bar Impact Testing  
Annex A5  
Converting Percentage Elongation of Round Specimens to
Equivalents for Flat Specimens  
Annex A6    
Testing Multi-Wire Strand  
Annex A7  
Rounding of Test Data  
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...

  • Standard
    51 pages
    English language
    sale 15% off
  • Standard
    51 pages
    English language
    sale 15% off
ASTM
ASTM D3495-10(2023)(Test Method)
Standard Test Method for Hexane Extraction of Leather

SIGNIFICANCE AND USE
3.1 This test method measures the amount of hexane-soluble lubricant present in all types of leather. Adequate lubrication prevents abrasion of leather fibers during flexing. This lubrication is generally obtained from the fat liquor added at the tannery. Some lubrication is also obtained from natural grease produced during the life of the animal.
SCOPE
1.1 This test method covers the quantitative extraction of all types of leather with hexane. This test method does not apply to wet blue.  
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.

  • Standard
    3 pages
    English language
    sale 15% off
ASTM
ASTM F981-23(Practice)
Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

SIGNIFICANCE AND USE
4.1 This practice is a guideline for short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and sterilization. The tissue responses to the test article are compared to the skeletal muscle and/or bone tissue response(s) elicited by control materials. The controls consistently demonstrate known cellular reaction and wound healing.
SCOPE
1.1 This practice provides guidelines for biological assessment of tissue responses to nonabsorbable for medical device implants. It assesses the effects of the material that is implanted intramuscularly or intraosseously. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, or mutagenicity of the material since other standards address these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or skeletal muscle tissue in excess of 30 days. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials are well recognized with a well-characterized long-term response and can include metals and any one of the metal alloys in Specification F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648, or USP polyethylene negative control.  
1.2 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems 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.

  • Standard
    5 pages
    English language
    sale 15% off
  • Standard
    5 pages
    English language
    sale 15% off
ASTM
ASTM C1157/C1157M-23(Specification)
Standard Performance Specification for Hydraulic Cement

SCOPE
1.1 This performance specification covers hydraulic cements for both general and special applications. There are no restrictions on the composition of the cement or its constituents (see Note 1).
Note 1: There are two related hydraulic cement standards, Specification C150/C150M for portland cement and Specifications C595/C595M for blended cements, both of which contain prescriptive and performance requirements  
1.2 This performance specification classifies cements based on specific requirements for general use, high early strength, resistance to attack by sulfates, and heat of hydration. Optional requirements are provided for the property of low reactivity with alkali-silica-reactive aggregates and for air-entraining cements.  
1.3 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. Values in SI units [or inch-pound units] shall be obtained by measurement in SI units [or inch-pound units] or by appropriate conversion, using the Rules for Conversion and Rounding given in IEEE/ASTM SI 10, of measurements made in other units [or SI units]. Values are stated in only SI units when inch-pound units are not used in practice.  
1.4 The text of this performance specification refers to notes and footnotes that provide explanatory material. These notes and footnotes (excluding those in tables and figures) are not requirements of the standard.  
1.5 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.  
1.6 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.

  • Technical specification
    5 pages
    English language
    sale 15% off
  • Technical specification
    5 pages
    English language
    sale 15% off