ASTM F565 - 04(2013)

    Standard Practice for Care and Handling of Orthopedic Implants and Instruments

    Active Standard ASTM F565 | Developed by Subcommittee: F04.21

    Book of Standards Volume: 13.01


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    Abstract

    This practice covers recommended procedures for the handling of orthopedic implants and instruments. Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage of orthopedic implants and instruments. Many implants are wrapped in special sterilizable or pre-sterilized packages, envelopes, or other containers. These wrappings should not be removed by the receiving personnel. Perform transport in a manner to preclude any damage or alteration to the received condition of the implant or instrument. Store implants or instruments prior to use in such a manner as to maintain the device?s surface finish or configuration, or both. Maintain orthopedic implants and instruments of different metals separately to avoid the possibility of mixing during surgery. Prior to initial sterilization and promptly following each surgical procedure, thoroughly and carefully clean all instruments and implants. Dispose of orthopedic implants that exhibit surface or configuration damage. Avoid the reimplantation of previously implanted orthopedic implants.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    1. Scope

    1.1  This practice covers recommended procedures for the handling of orthopedic implants and instruments.

    1.2  Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage to orthopedic implants and instruments.

    1.3  This practice does not cover producer level handling and packaging procedures.

    1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.


    ICS Code

    ICS Number Code 11.040.30 (Surgical instruments and materials); 11.040.40 (Implants for surgery, prothetics and orthotics)

    UNSPSC Code

    UNSPSC Code 42320000(Orthopedic surgical implants)


    Referencing This Standard

    DOI: 10.1520/F0565

    ASTM International is a member of CrossRef.

    Citation Format

    ASTM F565-04(2013), Standard Practice for Care and Handling of Orthopedic Implants and Instruments, ASTM International, West Conshohocken, PA, 2013, www.astm.org

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