GENERAL OVERVIEW ASTM Committee F04 on Medical and Surgical Materials and Devices was formed in 1962. F04 meets twice a year, in May and November, with approximately 160 members attending two days of technical meetings and a symposium or workshop on relevant topics in the medical/surgical materials and device industry. The Committee, with a membership of approximately 800, currently has jurisdiction over 200 standards published in September in the Annual Book of ASTM Standards, Volume 13.01. F04 has 22 technical subcommittees that maintain these standards. Information on this subcommittee structure and F04’s portfolio of approved standards and Work Items under development is available from the List of Subcommittees, Standards, and Work Items. These standards have and continue to play a preeminent role in all aspects important to medical and surgical materials, orthopedic devices, testing, tissue engineering, and medical/surgical instruments. ACTIVITIES, PRODUCTS, AND SERVICES The technical subcommittees of F04 collectively encompass five primary areas: resources, orthopaedic devices, medical and surgical devices, tissue engineered products, and computer-assisted surgical systems. The resources area addresses standards for materials such as ceramics, metals, and polymers; it also includes standards to address needed fundamental information on biocompatibility, test methodology, and magnetic resonance imaging. The orthopaedic devices area focuses on methods and practices for osteosynthesis, arthroplasty, and spinal devices. Standards under the medical and surgical device category pertain mostly to cardiology, neurology, audiology, gastroenterology, and plastic surgery. Tissue engineered medical products (TEMPs) standards focus on materials needed in, and practices and methods for, the development and application of TEMPs technologies. Lastly, a division on computer assisted surgical systems includes a subcommittee on computer-assisted orthopaedic surgical systems (CAOS), which is writing standards for system accuracy. The work of the Committee has promulgated more than 200 standards and numerous industry-critical publications such as STP 1431, Spinal Implants: Are We Evaluating Them Appropriately? and STP 1452, Tissue Engineered Medical Products. For a list of all F04 publications, click here. At any given time, F04 has dozens of standards activities under way. Some recent and ongoing development activities include the following initiatives. Subcommittee F04.37’s draft on implantable middle-ear hearing devices will aid millions of people living with sensorineural hearing loss by standardizing devices that work by directly vibrating the bones of the middle ear. Subcommittee F04.05’s draft technique of measuring and reporting performance of surgical navigation and/or robotic positioning devices so that standardized measurement of performance variables will allow end users to compare within and between different systems. Subcommittees F04.41 to F04.45 are developing a portfolio of standards for protein concentration, reference scaffolds, and articular cartilage performance – just to name a few. Subcommittee F04.25 is developing WK7479, Test Method for the Functional, Kinematic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants. As noted, these are only a few of the ongoing activities in F04. F04 conducts either a workshop or symposia at every meeting. These programs provide forums for discussing current topics for which standardization may be appropriate. Recent examples include workshops on finite element analysis and a symposium on the cleanliness of implants. More information can be found by reviewing the F04 meeting schedule as well as the committee’s symposia and workshop page. Admission for most F04 symposia is approximately $150, which often includes a publication of the peer-reviewed presentations. Workshops usually have a lesser fee, and the presentation materials can sometimes be made obtained by contacting the presenter. PARTICIPATING AS A MEMBER ON THE COMMITTEE ASTM International opens its doors to all technical experts with an interest in the standardization process. As a member of ASTM Committee F04, you will be exposed to the robust resources and member benefits included below that have helped make ASTM a worldwide standards development leader for more than a century: Network with industry professionals worldwide Receive one free volume of the Annual Book of ASTM Standards (in print or CD) Use Internet-based Standards Development Forums and E-Balloting Receive discounts on all ASTM publications Keep up to date through a free subscription to ASTM’s monthly magazine - Standardization News Benefit from reduced fees for attendance at ASTM symposia and technical workshops And more Members can participate from anywhere because of ASTM’s customized web-based systems. The best way to contribute as a member is to (1) participate in task group activities that are of interest (both virtually and in person), and (2) vote on ballots and provide feedback and recommendations. To participate in standards activities, start by identifying Work Items of interest by reviewing the List of Subcommittees, Standards, and Work Items on the F04 home page. Contact task group leaders for those areas of interest by reviewing the Work Item summary pages and securing contact information available through the on-line roster in the member area. To make the most of your voting and participation overall, be sure to stipulate which specific subcommittees you wish to participate in when you join so that you will receive notices of ballots that open within these groups. In order to continue to promote standards objectives for this fast-paced industry, F04 uses ASTM’s interactive media. This approach includes our web-based Interactive Forums, a document review and development system always available for capturing comments and maturing documents. Additionally, the Committee conducts virtual meetings in conjunction with conference calls, to accelerate document development and increase participation of its global membership in a real-time format. STAKEHOLDERS This Committee is largely composed of producers, users who are both practitioners and consumers, regulators, and associations. Producers are generally those individuals or companies that manufacture products in any given area of standardization by the Committee. This may include material production such as metals and polymers, or finished-product manufacturing as in the case of artificial disks and hips. Also, as would be expected, device and drug agencies from around the globe participate in the activities of F04. Regulators refer to any representative from a government agency, whether it is the Korean Food and Drug Administration, the U.S. Food and Drug Administration, or the National Institute of Standards and Technology. These stakeholders are important to the ASTM standards forum because they are often the largest users of standards. Regulators usually represent entities to which the industry looks for guidance and for information on product acceptance. Users may include various providers of services, such as mechanical testing of materials, or practitioners, who are surgeons, nurses, and other healthcare professionals who provide valuable working information about the use and effectiveness of standards. Additionally, organizations such as the American Academy of Orthopaedic Surgeons and the Orthopaedic Surgical Manufacturer’s Association, among others, participate to ensure that the needs of their respective constituents are being met and at the same time offer tremendous support to the Committee by sharing communication avenues and other resources. RELATIONSHIP WITH INDUSTRY, GOVERNMENT, AND REGULATION The standards of Committee F04 are used as the basis for regulations in many countries, including China, South Africa, and the United States, and they are critical to patient health because they ensure the safety and efficacy of medical devices and components. Typically, a regulation will reference F04 standards as acceptable methods of test, material specifications, and/or operational guidance as may be required for regulatory compliance. Particularly in the case of medical devices, a manufacturer’s declaration of conforming to standards recognized by the regulating agency can accelerate the acceptance and use of their product because it is presumed to conform to the law/regulation that references the standard. If a manufacturer states that a product has been manufactured in accordance with standards cited in regulation, when in fact the product does not conform, then the result is often serious legal penalties. F04 standards may also be used for engineering design, where companies rely on the standards for material specifications and performance requirements to be achieved by their devices. The standards facilitate communication with suppliers for the purposes of material procurement or product requirements. Independent laboratorial studies and universities use them for standard protocols, and manufacturers are able to rely on them for protection in product legal cases. Around the world, some of the most critical standards developed by Committee F04 include F 67, Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), and F 1801, Practice for Corrosion Fatigue Testing of Metallic Implant Materials. F04 standards are especially prevalent in high-tech and fast moving areas, where the Committee leads the world in standardization, such as in magnetic resonance imaging and in TEMPs standards such as F 2064, Guide for Characterization and Testing of Alginates as Starting Materials Intended for use in Biomedical and Tissue-Engineered Medical Products Application. LIAISON Key Organizations F04 has working relationships with many associations, such as the American Academy of Orthopaedic Surgeons (AAOS), the Orthopaedic Surgical Manufacturers Association (OSMA), the American Association of Blood Banks (AABB), and the Association for the Advancement of Medical Instrumentation (AAMI). Links to these and additional associations are provided below. AAOS and ASTM often work together to ensure that practitioners are in attendance at meetings of the Committee, and that issues of importance to the surgical community are integrated into developing standards. Similarly, OSMA supports F04 to ensure the Committee is able to coordinate global standards efforts that provide for transparency in trade for the manufacturing community. AABB, as a reference in various standards, is becoming more of an integral player in the registry of tissue for TEMPs-related issues. Finally, AAMI and AMS (American Metallurgical Society) are responsible for other medically related standards work also utilized in the medical and surgical device community. Standards developers work together to avoid overlap and they often share resources. The list of affiliated organizations goes on, but these are some of the key associations that have relationships with the Committee. ISO TC 150 Committee F04 also maintains an important coordinating role with the International Organization for Standardization (ISO). European regulatory agencies rely on both ISO and ASTM International standards; this necessitates that industries, through ASTM International, have a strong voice at ISO in order to coordinate the global work of these two standards bodies. Much effort is focused on ensuring that there is no duplication of internationally accepted standards already in existence. Within Technical Committee (TC) 150 on Implants for Surgery, F04 holds the U.S. Technical Advisory Group (TAG) to Subcommittee (SC) 1 on Materials, SC 3 on Neurosurgical Standards, SC 4 on Bone and joint replacements, SC 5 on Osteosynthesis and spinal devices, and WG 11 on Tissue engineered products. F04 also holds the secretariat for SC 5. LINKS AND INFORMATION The following websites have been identified by Committee F04 to contain information of interest. Advamed: www.advamed.org American Academy of Orthopaedic Surgeons: www.aaos.org American Association of Blood Banks: www.aabb.org ASM International: www.asminternational.org Biomat.net: www.biomat.net Orthopaedic Surgical Manufacturers Association: www.osma.cc Society for Biomaterials: www.biomaterials.org

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