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Committee F04 on Medical and Surgical Materials and …
- https://www.astm.org/get-involved/technical-committees/committee-F04
- F04 has 34 technical subcommittees that maintain jurisdiction over these standards. Information on this subcommittee structure and F04's portfolio of approved standards and Work Items under construction are available from the List of Subcommittees, Standards …
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 …
Committee F04 Subcommittees - ASTM International
- https://www.astm.org/get-involved/technical-committees/committee-f04/subcommittee-f04
- Standards under the jurisdiction of F04. Each main committee in ASTM International is composed of subcommittees that address specific segments within the general subject …
Modeling the Future of Medical Devices - ASTM …
- https://sn.astm.org/features/modeling-future-medical-devices-jf20.html
- Computational modeling is now an accepted part of the FDA approval process. As a result, in November 2019, medical device professionals gathered at a workshop, Medical …
Safety of Metals and Other Materials Used in Medical …
- https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices
- The FDA accepted feedback through August 18, 2021 in a public docket FDA-2021-N-0334 . Numerous types of materials, including metals, polymers and …
Materials for Medical Manufacturing
- https://www.sme.org/technologies/articles/2011/materials-medical-manufacturing/
- But that was between the surgeon and the patient. Later on, the ASTM F4 committee was established with a lot of orthopedic surgeons, and we started creating the standards for these …
Section 13: Medical Devices and Services - ASTM …
- https://www.astm.org/products-services/astm-bos-13.html
- This section includes Volumes 13.01 through 13.02: ASTM Volume 13.01: Medical And Surgical Materials And Devices (I): E667–F2477. ASTM Volume 13.02: Medical And …
Standard Practice for Marking Medical Devices and …
- https://www.astm.org/f2503-20.html
- 4.3 This practice provides a uniform system for marking to indicate the conditions for which it has been determined that a medical device or other item may be …
Standard Guide for Accelerated Aging of Sterile
- https://www.astm.org/f1980-21.html
- 1.1 This guide provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the …
Standard Practice for Marking Medical Devices and …
- https://www.astm.org/f2503-08.html
- Medical devices and other items have caused serious injuries and death for patients and other individuals in the MR environment. ... ASTM grants Licensee a limited, …
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