ASTM F1377-21 PDF
Name in English:
St ASTM F1377-21
Name in Russian:
Ст ASTM F1377-21
Original standard ASTM F1377-21 in PDF full version. Additional info + preview on request
Full title and description
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538). This specification defines chemical, particle-size (sieve) and cleanliness requirements for Co‑28Cr‑6Mo alloy powders intended for use in medical-device fabrication and for forming coatings by sintering or thermal spraying; it covers powder requirements only and does not address coating or finished‑component properties.
Abstract
This specification covers cobalt‑28chromium‑6molybdenum alloy powders for coating of orthopedic implants and for use in fabricating cobalt‑28chromium‑6molybdenum alloy medical devices. Materials may be produced by rotating electrode process, inert‑gas atomization, or other methods that meet the powder requirements; the powder must conform to specified chemistry, sieve analysis, and cleanliness limits. The document explicitly excludes requirements for coatings or components formed from the powders.
General information
- Status: Published / Active.
- Publication date: December 1, 2021 (designation F1377‑21).
- Publisher: ASTM International.
- ICS / categories: 11.040.40 (Implants for surgery; prothetics and orthotics).
- Edition / version: F1377‑21 (revises F1377‑13).
- Number of pages: 3 pages.
Scope
The standard applies to cobalt‑28Cr‑6Mo alloy powders (UNS R30075, UNS R31537, UNS R31538) intended for use in fabricating medical devices or for creating porous/adhesive coatings on implants by sintering, thermal spraying, metal injection molding, or additive manufacturing processes. It addresses powder chemistry, particle‑size (sieve) distribution and cleanliness; it does not prescribe coating properties or finished‑device performance.
Key topics and requirements
- Chemical composition limits for Co‑28Cr‑6Mo alloy powders (matching UNS R30075, R31537, R31538 requirements).
- Particle‑size (sieve) distribution and allowable size fractions for powder lots.
- Cleanliness and contamination limits (inclusion/oxide/foreign‑matter control) for powders intended for medical use.
- Accepted powder manufacture methods (rotating electrode, inert‑gas atomization, etc.) provided the powder meets the specification.
- Ordering and material‑identification provisions (requirements to specify method, sieve analysis, special tests and other purchase information).
- Units and measurement: SI and inch‑pound values are provided and must be used independently (do not combine).
Typical use and users
Primary users include medical‑device manufacturers (orthopedic implant producers), powder producers and suppliers, additive‑manufacturing and metal‑injection‑molding engineers, coatings and thermal‑spray service providers, and regulatory/compliance teams preparing device submissions. The standard is used when specifying and purchasing Co‑28Cr‑6Mo powders for implant coatings or for fabrication of implant components.
Related standards
Related ASTM standards and specifications commonly referenced with F1377 include ASTM F75 (cast Co‑28Cr‑6Mo implant alloys), ASTM F1537 (wrought Co‑28Cr‑6Mo alloys for surgical implants), and other F04 committee documents and test methods for chemical analysis and particle testing. The standard also sits alongside quality and medical device system standards such as ISO 9001 and ISO 13485 that are relevant to manufacturers.
Keywords
Additive manufacturing, coatings, cobalt‑chromium‑molybdenum, Co‑28Cr‑6Mo, UNS R30075, UNS R31537, UNS R31538, powder metallurgy, metal injection molding, thermal spray, rotating electrode, inert gas atomization, orthopedic implants, porous coatings, sieve analysis, powder cleanliness.
FAQ
Q: What is this standard?
A: ASTM F1377‑21 is the ASTM International standard specification that defines requirements for cobalt‑28chromium‑6molybdenum (Co‑28Cr‑6Mo) alloy powders intended for medical‑device fabrication and for producing coatings on orthopedic implants.
Q: What does it cover?
A: It covers powder chemistry, particle‑size (sieve) distribution and cleanliness requirements, allowed manufacturing processes for the powder, ordering information, and related measurement units; it does not cover the properties of coatings or finished components made from the powder.
Q: Who typically uses it?
A: Powder manufacturers/suppliers, implant and medical‑device manufacturers, additive‑manufacturing engineers, coatings/thermal‑spray processors, purchasing/specification writers, and regulatory teams.
Q: Is it current or superseded?
A: Current (active) as designation F1377‑21; it revises the prior F1377‑13 edition. The document is published by ASTM International and listed as active in ASTM/ANSI catalogs. Additionally, it has been recognized for use in medical‑device regulatory contexts (entry recorded by the FDA's recognized consensus standards database).
Q: Is it part of a series?
A: It is part of ASTM Committee F04's body of standards for medical and surgical materials and devices and is normally used alongside related specifications for cobalt‑chromium alloys (for example ASTM F75 and F1537) and applicable test methods.
Q: What are the key keywords?
A: Co‑28Cr‑6Mo, cobalt‑chromium‑molybdenum, powder, additive manufacturing, thermal spray, metal injection molding, orthopedic implants, sieve analysis, powder cleanliness.