A customer has approached Carpenter Technology about adding BioDur 470/Custom 470 to ASTM F899. They produce medical devices, but to register the devices abroad they are required to refer to an industry specification such as an ASTM document. This major medical device OEM cannot use the material in their designs without its inclusion in an ASTM specification. This effort will also require the designation of a UNS number to the alloy. In the future, we intend to also add the alloy to ASTM A564. The end-user supporting letter from Smith & Nephew and chemistry from 3 heats are to be submitted for ballot. F899 X1.10.4 requires the subcommittee to be informed if a new alloy is covered by a patent. Custom 470 is covered by U.S. Patent 6,238,455 issued to Carpenter Technology. 12/19/11 Note: This work item received a negative vote during the ballot that closed 10/ 30/11 because ASTM F899 Section 8.1 states, Material shall conform to the mechanical property requirements cited in the appropriate ASTM standards (see 2.1) however, the second half of that statement, or shall meet the mechanical property requirements specified by the purchaser was omitted by the negative voter. Since no ASTM specification exists for precipitation hardenable stainless steels in wire form, the chemistry requirements for BioDur 470/ Custom 470 can be included in F 899. Per section 1.1 of ASTM F 899: Mechanical property requirements, heat treating requirements, hardness requirements and all other requirements except chemistry are governed by the appropriate material standards as referenced below or as agreed upon between purchaser and supplier. 10/12/2016 Re-Submitting this ballet. The negatives are being addressed which include biocompatibility information and request for UNS number. I will also be adding two additional alloys, Trinamet (UNS S42030) and CarTech CTS XHP Alloy (UNS pending) that customers have shown interest to be included in F899.
Keywordsaustenitic; ferritic; instruments; martensitic; precipitation hardenable; stainless steel; surgical; Surgical instruments--specifications; Stainless steel bars/billets--specifications; Stainless steel surgical applications--specifications; Steel billets and blooms--specifications; Steel wire--specifications;
Negative Votes Need Resolution