ASTM WK70040

    Revision of F899 - 12b Standard Specification for Wrought Stainless Steels for Surgical Instruments

    (What is a Work Item?)

    Active Standard: F899 - 19

    Developed by Subcommittee: F04.12 | Committee F04 | Contact Staff Manager



    WK70040


    Keywords

    austenitic; ferritic; instruments; martensitic; precipitation hardenable; stainless steel; surgical;

    Rationale

    As of 26 May 2020, the new EU Medical Devices Regulation (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices) will require manufacturers to label certain medical devices that contain CMR (carcinogenic, mutagenic, reprotoxic) 1A or 1B or endocrine disrupting substances in a concentration above 0.1% (including residuals and impurities). This requirement will among others apply to devices that are invasive and come into direct contact with the human body, such as surgical instruments. Cobalt will soon receive an EU-wide harmonised classification (by means of the EU CLP Regulation) as CMR 1B substance (carcinogen 1B, reprotox 1B, mutagen 2). This will trigger the MDR labelling requirement for surgical instruments made from stainless steel with cobalt levels above 0.1% w/w. A major issue with stainless steel is that cobalt is not typically reported on the certificates. Therefore, medical device manufacturers do not have reliable cobalt information for all the lots of stainless steel used in components. The proposed change includes a reporting requirement for the amount of cobalt in all the stainless steel grades that are specified in this standard. This would ensure consistency in labelling of medical devices containing the same stainless steel grades.

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    Work Item Status

    Date Initiated:
    09-26-2019

    Technical Contact:
    Lasse Langner

    Item:
    001

    Ballot:
    F04.12 (19-04)

    Status:
    In Balloting