ASTM F565-21

ASTM F565-21

Standard Practice for Care and Handling of Orthopedic Implants and Instruments

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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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


Rationale:

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.

Additional Info

Author American Society for Testing and Materials (ASTM International)
Committee F04.21 - Committee F04 on Medical and Surgical Materials and Devices
Published by ASTM
Document type Standard
Theme ,Surgical instruments and materials,Implants for surgery, prothetics and orthotics
ICS 11.040.30 : Surgical instruments and materials
11.040.40 : Implants for surgery, prosthetics and orthotics
Number of pages 3
Replace ASTM F565-04(2018)
Set ASTM Volume 13.01 - Multi-User - Single-Site Online
Document history ,,,,,
Keyword F565

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