Committee F04 Medical and Surgical Materials and Deviceswww.astm.org

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September 2014

F04 Subcommittees The 34 subcommittees that make up Committee F04 collectively cover five primary areas: resources, orthopaedic devices, medical and surgical devices, tissue engineered products, and computer-assisted surgical systems.

ͽ F04.01, Division I - Resources

ͽ F04.11, Polymeric Materials

ͽ F04.12, Metallurgical Materials

ͽ F04.13, Ceramic Materials

ͽ F04.15, Material Test Methods

ͽ F04.16, Biocompatibility Test Methods

ͽ F04.18, Device Retrieval Analysis

ͽ F04.02, Division II - Orthopaedic Devices

ͽ F04.21, Osteosynthesis

ͽ F04.22, Arthroplasty

ͽ F04.25, Spinal Devices

ͽ F04.03, Division III - Medical/Surgical Devices

ͽ F04.30, Cardiovascular Standards

ͽ F04.31, Neurosurgical Standards

ͽ F04.32, Plastic and Reconstructive Surgery

ͽ F04.33, Medical/Surgical Instruments

ͽ F04.34, Urological Materials and Devices

ͽ F04.35, GI Applications

ͽ F04.37, Implantable Hearing Devices (IHDs)

ͽ F04.38, Computer Assisted Orthapaedic Surgical Systems

ͽ F04.39, Human Clinical Trials

ͽ F04.04, Division lV - Tissue Engineered Medical Products

ͽ F04.41, Classification and Terminology for TEMPs

ͽ F04.42, Biomaterials and Biomolecules for TEMPs

ͽ F04.43, Cells and Tissue Engineered Constructs for TEMPs

ͽ F04.44, Assessment for TEMPs

ͽ F04.45, Adventitious Agents Safety

ͽ F04.46, Cell Signaling

ͽ F04.93, U.S. TAG ISO/TC 150 - Implants for Surgery

ͽ F04.95, U.S. TAG ISO/TC 168 - Prosthetics and Orthotics

ͽ F04.97, Editorial and Terminology

900Technical Experts

Working with Key OrganizationsF04 has working relationships with many associations, including the American Academy of Orthopaedic Surgeons (AAOS), the Orthopaedic Surgical Manufacturers Association (OSMA), the American Association of Blood Banks (AABB), the Association for the Advancement of Medical Instrumentation (AAMI), and the U.S. Food and Drug Administration.

F04 StandardsF04 subcommittees oversee more than 300 new and existing standards published in Volumes 13.01 and 13.02 of the Annual Book of ASTM Standards, including:

ͽ ASTM F2211, Standard Classification for Tissue Engineered Medical Products (TEMPs)

ͽ ASTM F2311, Standard Guide for Classification of Therapeutic Skin Substitutes

ͽ ASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

ͽ ASTM F2554, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

ͽ ASTM F2900, Standard Guide for Characterization of Hydrogels Used in Regenerative Medicine

ͽ ASTM F2943, Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants

ͽ ASTM F2996, Standard Practice for Finite Element Analysis (FEA) of Nonmodular Metallic Orthopaedic Hip Femoral Stems

ͽ ASTM F3014, Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures

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ASTM Staff Manager for Committee F04Pat Picariello tel +1.610.832.9720 ppicariello@astm.org www.astm.org/COMMIT/F04

MeetingsASTM Committee F04 welcomes participation in the development of its standards. The committee meets twice a year, in May and November, attending over two days of technical meetings capped by a symposium or workshop on relevant topics in the medical/surgical materials and devices industry.

MembershipASTM International welcomes all technical experts with a desire to work toward further development of international technical standards. Membership in Committee F04 provide the opportunity to:

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ͽ Receive a free volume of the Annual Book of ASTM Standards (print, CD or virtual volume);

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ͽ Benefit from reduced attendance fees at ASTM symposia and technical workshops.

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300Published Standards

Formed in 1963, ASTM Committee F04 develops recommended practices, guides, specifications, nomenclature and definitions of terms and performance standards for medical and surgical materials and devices. These standards cover a range of topics for many segments of the medical industry, from orthopaedics, arthroplasty and tissue engineering, to neurosurgical, cardiovascular, plastic surgery and much more. F04’s membership of more than 900 technical experts, including physicians, healthcare professionals, regulators, government agencies and manufacturers, come from 35 countries and oversee more than 300 published standards, with dozens more under development.