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Astm Standard Articles & Analysis

35 news found

STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance

STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance

STEMart's experienced team assists clients in meeting stringent regulatory standards, including ISO 10992, ISO 18562, FDA guidance, and ASTM standards. ...

BySTEMart


Spores for Fighting Disease

Spores for Fighting Disease

A new ASTM standard provides an easy-to-perform test method for growing different strains of Clostridium difficile spores, which are used by microbiologists to evaluate antimicrobial drugs. ...

ByASTM International


TTIP and dancing elephants

TTIP and dancing elephants

ASTM International and other standards organizations domiciled in the U.S. admit technical experts from other countries into their standardization processes and are increasingly globally focused. ...

ByASTM International


ASTM F2914 - 12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices

ASTM F2914 - 12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices

Combination and biodegradable devices (for example drug-devices, biologic devices or drug biologics) may require additional considerations, depending on their nature. 1.2 This guide does not directly provide any test methods for conducting shelf-life testing. 1.3 This standard does not purport to address all of the safety ...

ByASTM International


ASTM F1044 - 05(2011)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

ASTM F1044 - 05(2011)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

Combining values from the two systems may result in non-conformance with the standard. 1.3 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. ...

ByASTM International


ASTM F1160 - 05(2011)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

ASTM F1160 - 05(2011)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

Combining values from the two systems may result in non-conformance with the 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 ...

ByASTM International


ASTM F2180 - 02(2011)e1 Standard Specification for Metallic Implantable Strands and Cables

ASTM F2180 - 02(2011)e1 Standard Specification for Metallic Implantable Strands and Cables

Standard strand constructions shall be 1×3, 1×7, and 1×19 strand. ...

ByASTM International


ASTM F2267 - 04(2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

ASTM F2267 - 04(2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

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. 2. Referenced Documents (purchase separately) ...

ByASTM International


ASTM F1855 - 00(2011) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications

ASTM F1855 - 00(2011) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any ...

ByASTM International


ASTM F2042 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication

ASTM F2042 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication

Referenced Documents (purchase separately) ASTM Standards D395 Test Methods for Rubber Property--Compression Set D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension D430 Test Methods for Rubber Deterioration--Dynamic Fatigue D624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers D792 ...

ByASTM International


ASTM F755 - 99(2011) Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

ASTM F755 - 99(2011) Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation ...

ByASTM International


ASTM F136 - 11 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

ASTM F136 - 11 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation ...

ByASTM International


ASTM F2038 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

ASTM F2038 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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 ...

ByASTM International


ASTM F603 - 12 Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

ASTM F603 - 12 Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

It is intended as a qualification of the material as delivered to the parts manufacturer. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. Index Terms advanced ceramics; alumina; aluminum oxide; ceramic; surgical implant ICS Code DOI: ...

ByASTM International


Withdrawn Standard: ASTM F1251-89(2003) Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)

Withdrawn Standard: ASTM F1251-89(2003) Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)

The listing is also intended to define terms that appear prominently within other ASTM standards and do not appear elsewhere. 1.3 The definitions are substantially identical to those published in ...

ByASTM International


ASTM E787 - 81(2011) Standard Specification for Disposable Glass Micro Blood Collection Pipets

ASTM E787 - 81(2011) Standard Specification for Disposable Glass Micro Blood Collection Pipets

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any ...

ByASTM International


ASTM F2083 - 11 Standard Specification for Total Knee Prosthesis

ASTM F2083 - 11 Standard Specification for Total Knee Prosthesis

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents ...

ByASTM International


ASTM A928 / A928M - 11 standard specification for ferritic/austenitic (Duplex) stainless steel pipe electric fusion welded with addition of filler metal

ASTM A928 / A928M - 11 standard specification for ferritic/austenitic (Duplex) stainless steel pipe electric fusion welded with addition of filler metal

This specification covers standard requirements for ferritic/austenitic (duplex) stainless steel pipe that is electric fusion welded with addition of filler metal suitable for corrosive service. ...

ByASTM International


ASTM F629 - 11 standard practice for radiography of cast metallic surgical implants

ASTM F629 - 11 standard practice for radiography of cast metallic surgical implants

Scope 1.1 This practice covers the procedure for radiographic testing of cast metallic surgical implants and related weldments. 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 ...

ByASTM International


ASTM A453 / A453M - 11 standard specification for high-temperature bolting, with expansion coefficients comparable to austenitic stainless steels

ASTM A453 / A453M - 11 standard specification for high-temperature bolting, with expansion coefficients comparable to austenitic stainless steels

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents ...

ByASTM International

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