As a manufacturer, would you like to carry out an analysis of your surgical implants according to the ASTM F1586-21 standard?
What is the ASTM F1586-21 standard?
ASTM F1586-21 is a standard specification that defines the chemical, mechanical and metallurgical requirements for nitrogen-reinforced austenitic stainless steel bars containing 21% chromium, 10% nickel, 3% manganese and 2.5% molybdenum (UNS designation S31675). These bars are mainly used in the manufacture of surgical implants.
This standard covers the following aspects
- Chemical composition: specifies the percentages required for each constituent element of the alloy.
- Mechanical properties : defines characteristics such as tensile strength, yield strength and elongation.
- Metallurgical properties : includes guidelines on microstructure and appropriate heat treatments.
The main objective of this standard is to ensure that materials used for surgical implants meet strict criteria for biocompatibility, corrosion resistance and mechanical performance, thereby guaranteeing the safety and effectiveness of medical devices manufactured from these alloys.
When should an analysis be carried out according to the ASTM F1586-21 standard?
ASTM F1586-21 is a standard specification for alloys composed of 21% chromium, 10% nickel, 3% manganese and 2.5% molybdenum in bar form.
These materials are frequently used in the manufacture of surgical implants, such as those used in orthopaedics and dental surgery.
The standard defines performance criteria, including chemical composition, mechanical properties, biocompatibility characteristics and other aspects that ensure materials are suitable for their intended use in implantable medical devices. The FILAB laboratory offers analyses for the characterization of materials in your medical devices.
The FILAB laboratory can help you comply with the ASTM F1586-21 standard
With modern analytical equipment and a team specialising in materials analysis, the FILAB laboratory assists industrial companies in managing their challenges related to the production of water-activated polyurethane glass fibre orthopaedic tapes. We offer full support in chemical and materials analysis tailored to your specific needs.
Our services dedicated to medical devices
R&D support: custom chemical analysis, material and surface characterization, analytical development
Process validation: Cleaning (ISO 19227), surface treatment
Other astm standards at filab
