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Medical Device Standards and Implant Standards

    https://www.astm.org/products-services/standards-and-publications/standards/medical-device-standards-and-implant-standards.html
    ASTM's medical device and implant standards are instrumental in specifying and evaluating the design and performance requirements of a number of biomedical materials, tools, and equipments. These apparatuses are used in surgical procedures that involve …

New ASTM Medical and Surgical Materials Standard …

    https://newsroom.astm.org/new-astm-medical-and-surgical-materials-standard-addresses-orthopedic-implant-labeling
    A new ASTM International guide addresses variable labeling within the orthopedic implant industry. ASTM F2943, Guide for Presentation of End User Labeling Information for …

Standard Practice for Retrieval and Analysis of Medical …

    https://www.astm.org/f0561-19.html
    5.1 The investigation of retrieved implantable medical devices and adjacent tissues can be of value in the assessment of clinical complications associated with the use of a specific …

ASTM Medical Materials Committee Approves New …

    https://newsroom.astm.org/astm-medical-materials-committee-approves-new-standard-metal-injection-molded-surgical-implant
    ASTM F2885, Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications, was developed by Subcommittee F04.12 …

Standard Supports Surgical Implant Safety - ASTM …

    https://sn.astm.org/update/standard-supports-surgical-implant-safety-mj19.html
    A new ASTM International standard aims to help determine the safety of surgical implants and prevent potentially adverse effects on patients. ASTM’s committee on medical and …

Orthopedic Implant Labeling | ASTM Standardization News

    https://sn.astm.org/update/orthopedic-implant-labeling-ja13.html
    A new ASTM International guide addresses variable labeling within the orthopedic implant industry. F2943, Guide for Presentation of End User Labeling Information for Orthopedic …

Biocompatibility of Implantable Medical Devices - ASTM …

    https://sn.astm.org/update/biocompatibility-implantable-medical-devices-jf14.html
    A proposed new ASTM International standard will be used to help assess device performance by examining the potential for galvanic corrosion of implants. WK19883 , …

Testing and Labeling Medical Devices for Safety in …

    https://www.fda.gov/media/74201/download
    Medical electrical equipment ---- Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. 8. …

MRI Safety and Compatibility of Implants and Medical …

    https://www.astm.org/stp11156s.html
    The MR environment produces unique safety and compatibility issues for materials used in implants and medical devices. The principal issues for MR safety and …

ASTM Standards - Medical Device Testing Services

    https://devicetesting.com/standards-astm.cfm
    ASTM Standards. ASTM International, www.astm.org, is a globally recognized leader in the development and delivery of voluntary consensus standards. Its F04 committee on …



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