ASTM F565-04(2013)

Standard Practice for Care and Handling of Orthopedic Implants and Instruments

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.
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.

General Information

• Status: Historical
• Publication Date: 30-Sep-2013
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.21 - Osteosynthesis

Relations

• Replaces: ASTM F565-04(2009)e1 - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• Effective Date: 01-Oct-2013
• Referred By: ASTM F1611-20 - Standard Specification for Intramedullary Reamers
• Effective Date: 01-Oct-2013
• Referred By: ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
• Effective Date: 01-Oct-2013
• Referred By: ASTM F382-17 - Standard Specification and Test Method for Metallic Bone Plates
• Effective Date: 01-Oct-2013
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 01-Oct-2013
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Oct-2013
• Referred By: ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• Effective Date: 01-Oct-2013
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 01-Oct-2013
• Referred By: ASTM F2721-09(2023) - Standard Guide for Preclinical <emph type="ital">in vivo</emph> Evaluation in Critical-Size Segmental Bone Defects
• Effective Date: 01-Oct-2013
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 01-Oct-2013
• Referred By: ASTM F2529-13(2021) - Standard Guide for <emph type="ital"> in vivo</emph> Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
• Effective Date: 01-Oct-2013
• Referred By: ASTM F2884-21 - Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation of Spinal Fusion
• Effective Date: 01-Oct-2013
• Referred By: ASTM F1264-16e1 - Standard Specification and Test Methods for Intramedullary Fixation Devices
• Effective Date: 01-Oct-2013
• Referred By: ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 01-Oct-2013
• Referred By: ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• Effective Date: 01-Oct-2013

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F565 − 04 (Reapproved 2013)
Standard Practice for
Care and Handling of Orthopedic Implants and Instruments
ThisstandardisissuedunderthefixeddesignationF565;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Receiving Implants and Instruments
1.1 This practice covers recommended procedures for the 3.1 Receipt:
handling of orthopedic implants and instruments.
3.1.1 Many implants are wrapped in special sterilizable or
pre-sterilized packages, envelopes, or other containers. These
1.2 Hospital receiving personnel, central supply personnel,
wrappings should not be removed by the receiving personnel.
operating room personnel, surgeons, and occasionally other
3.1.2 Carefully unwrap and handle non-sterilized implants
individuals will handle orthopedic implants and instruments.
and instruments upon receipt to avoid scratching, marking, or
All personnel should be informed of recommended care and
abrasion by other implants, instruments, unpacking tools, or by
handling procedures to prevent damage to orthopedic implants
dropping or otherwise endangering the surface finish or con-
and instruments.
figuration.
1.3 This practice does not cover producer level handling
3.2 Transport—Perform transport in a manner to preclude
and packaging procedures.
any damage or alteration to the received condition of the
1.4 The values stated in SI units are to be regarded as
implant or instrument.
standard. No other units of measurement are included in this
3.3 Storage:
standard.
3.3.1 Store implants or instruments prior to use in such a
1.5 This standard does not purport to address all of the
manner as to maintain the device’s surface finish or
safety concerns, if any, associated with its use. It is the
configuration, or both.
responsibility of the user of this standard to establish appro-
3.3.2 Manyimplantsareidentifiedbyaserialorlotnumber,
priate safety and health practices and determine the applica-
or both, on the package label, package insert, or surface of the
bility of regulatory limitations prior to use.
device. Record these control numbers and retain for transfer to
2. Terminology patient records, to facilitate inventory, stock rotation, medical
device reporting, and possible traceability to the manufacturer.
2.1 Definitions of Terms Specific to This Standard:
3.3.3 Stock Rotation—The principle of first in, first out, is
2.1.1 orthopedic implant—a device introduced by surgically
recommended.
penetrating the skin or mucosa of the body with the intention
3.3.4 Storeimplantsintheoperatingroominsuchamanner
that it remain within or attached to the skeleton within the body
as to isolate and protect the implant’s surface, sterility, and
following the surgery. This device is referred to in this practice
configuration. Keep implants made of different metals sepa-
as an “implant.”
rated.
2.1.2 orthopedic instrument—any cooperative device used
3.3.5 Store the implants and instruments in the operating
during surgical procedures involving the implantation of or-
room in such a manner as to isolate the instruments from the
thopedic implants. This device is referred to in this practice as
implants.
an “instrument.”
4. Handling
4.1 Mixing Metals—Maintain orthopedic implants and in-
struments of different metals separately to avoid the possibility
of mixing during surgery.
4.2 Cleaning and Sterilization:
4.2.1 Prior to initial sterilization and promptly following
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
each surgical procedure, thoroughly and carefully clean all
F04.21 on Osteosynthesis.
instruments and implants. Ultrasonic cleaners, mechanized
Current edition approved Oct. 1, 2013. Published October 2013. Originally
washers, or hand scrubbing are suitable methods, if carefully
approved in 1978. Last previous edition approved in 2009 as F565 – 04 (2009)ε1.
DOI: 10.1520/F0565-04R13. done. The method employed should be utilized to prevent
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F565 − 04 (2013)
impact, scratching, bending, or surface contact with any 4.4.2 It is recommended that metallic orthopedic implants
materials that
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