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ASTM F565-21

Current Revision

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.


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.


SDO ASTM: ASTM International
Document Number F565
Publication Date April 1, 2021
Language en - English
Page Count 3
Revision Level 21
Supercedes
Committee F04.21
Publish Date Document Id Type View
April 1, 2021 F0565-21 Revision
April 1, 2009 F0565-04R09E01 Revision
Oct. 1, 2004 F0565-04 Revision
Nov. 10, 2000 F0565-00 Revision
Feb. 1, 2018 F0565-04R18 Reaffirmation
Oct. 1, 2013 F0565-04R13 Reaffirmation
April 1, 2009 F0565-04R09 Reaffirmation
April 10, 2003 F0565-00R03 Reaffirmation