ASTM F565-04(2009)

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 of orthopedic implants and instruments.
1.3 This practice does not cover producer level handling and packaging procedures.
1.4 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: 31-Mar-2009
• 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 - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• Effective Date: 01-Apr-2009
• Replaced By: ASTM F565-04(2009)e1 - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• Effective Date: 01-Apr-2009
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 01-Apr-2009
• Referred By: ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 01-Apr-2009
• 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-Apr-2009
• Referred By: ASTM F1264-16e1 - Standard Specification and Test Methods for Intramedullary Fixation Devices
• Effective Date: 01-Apr-2009
• Referred By: ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• Effective Date: 01-Apr-2009
• 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-Apr-2009
• 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-Apr-2009
• Referred By: ASTM F1611-20 - Standard Specification for Intramedullary Reamers
• Effective Date: 01-Apr-2009
• Referred By: ASTM F2884-21 - Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation of Spinal Fusion
• Effective Date: 01-Apr-2009
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Apr-2009
• Referred By: ASTM F382-17 - Standard Specification and Test Method for Metallic Bone Plates
• Effective Date: 01-Apr-2009
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 01-Apr-2009
• Referred By: ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
• Effective Date: 01-Apr-2009

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 2009)
Standard Practice for
1
Care and Handling of Orthopedic Implants and Instruments
This standard is issued under the fixed designation F 565; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2 Transport—Perform transport in a manner to preclude
any damage or alteration to the received condition of the
1.1 This practice covers recommended procedures for the
implant or instrument.
handling of orthopedic implants and instruments.
3.3 Storage:
1.2 Hospital receiving personnel, central supply personnel,
3.3.1 Store implants or instruments prior to use in such a
operating room personnel, surgeons, and occasionally other
manner as to maintain the device’s surface finish or configu-
individuals will handle orthopedic implants and instruments.
ration, or both.
All personnel should be informed of recommended care and
3.3.2 Manyimplantsareidentifiedbyaserialorlotnumber,
handling procedures to prevent damage of orthopedic implants
or both, on the package label, package insert, or surface of the
and instruments.
device. Record these control numbers and retain for transfer to
1.3 This practice does not cover producer level handling
patient records, to facilitate inventory, stock rotation, medical
and packaging procedures.
device reporting, and possible traceability to the manufacturer.
1.4 This standard does not purport to address all of the
3.3.3 Stock Rotation—The principle of first in, first out, is
safety concerns, if any, associated with its use. It is the
recommended.
responsibility of the user of this standard to establish appro-
3.3.4 Store implants in the operating room in such a manner
priate safety and health practices and determine the applica-
as to isolate and protect the implant’s surface, sterility, and
bility of regulatory limitations prior to use.
configuration. Keep implants made of different metals sepa-
2. Terminology rated.
3.3.5 Store the implants and instruments in the operating
2.1 Definitions of Terms Specific to This Standard:
room in such a manner as to isolate the instruments from the
2.1.1 orthopedic implant—adeviceintroducedbysurgically
implants.
penetrating the skin or mucosa of the body with the intention
that it remain within or attached to the skeleton within the body
4. Handling
following the surgery. This device is referred to in this practice
4.1 Mixing Metals—Maintain orthopedic implants and in-
as an “implant.”
struments of different metals separately to avoid the possibility
2.1.2 orthopedic instrument—any cooperative device used
of mixing during surgery.
during surgical procedures involving the implantation of or-
4.2 Cleaning and Sterilization:
thopedic implants. This device is referred to in this practice as
4.2.1 Prior to initial sterilization and promptly following
an “instrument.”
each surgical procedure, thoroughly and carefully clean all
3. Receiving Implants and Instruments
instruments and implants. Ultrasonic cleaners, mechanized
washers, or hand scrubbing are suitable methods, if carefully
3.1 Receipt:
done. The method employed should be utilized to prevent
3.1.1 Many implants are wrapped in special sterilizable or
impact, scratching, bending, or surface contact with any
pre-sterilized packages, envelopes, or other containers. These
materials that might affect the implant or instrument surface or
wrappings should not be removed by the receiving personnel.
configuration.
3.1.2 Carefully unwrap and handle non-sterilized implants
4.2.2 Closely follow the manufacturer’s recommendations
and instruments upon receipt to avoid scratching, marking, or
on cleaning. In hand scrubbing, use soft brushes and avoid
abrasion by other implants, instruments, unpacking tools, or by
harsh chemicals or harsh cleaning solutions.
dropping or otherwise endangering the surface finish or con-
4.2.3 After cleaning, rinse the orthopedic implants and
figuration.
instruments completely free of all residuals, soap, detergent, or
cleaning solutions. Following rinsing, dry them thoroughly.
1
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
Devote special attention to hinges, pivots, box locks, and other
Surgical Materials and Devices and is the direct responsibility of Subcommittee
recesses since these are points that entrap both chemicals and
F04.21 on Osteosynthesis.
rinse water.
Current edition approved April 1, 2009. Published April 2009. Originally
approved in 1978. Last previous edition approved in 2004 as F 565 – 04.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United S
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F565–00 (Reapproved 2003) Designation: F 565 – 04 (Reapproved 2009)
Standard Practice for
1
Care and Handling of Orthopedic Implants and Instruments
This standard is issued under the fixed designation F 565; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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 of orthopedic implants and instruments.
1.3 This practice does not cover producer level handling and packaging procedures.
1.4 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.
2. Terminology
2.1 Definitions of Terms Specific to This Standard:
2.1.1 orthopedic implant—a device introduced by surgically penetrating the skin or mucosa of the body with the intention that
it remain within or attached to the skeleton within the body following the surgery. This device is referred to in this practice as an
“implant.”
2.1.2 orthopedic instrument—any cooperative device used during surgical procedures involving the implantation of orthopedic
implants. This device is referred to in this practice as an “instrument.”
3. Receiving Implants and Instruments
3.1 Receipt:
3.1.1 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.
3.1.2 Carefully unwrap and handle non-sterilized implants and instruments upon receipt to avoid scratching, marking, or
abrasion by other implants, instruments, unpacking tools, or by dropping or otherwise endangering the surface finish or
configuration.
3.2 Transport—Perform transport in a manner to preclude any damage or alteration to the received condition of the implant or
instrument.
3.3 Storage:
3.3.1 Store implants or instruments prior to use in such a manner as to maintain the device’s surface finish or configuration,
or both.
3.3.2 Many implants are identified by a serial or lot number, or both, on the package label, package insert, or surface of the
device. Record these control numbers and retain for transfer to patient records, to facilitate inventory, stock rotation, medical
device reporting, and possible traceability to the manufacturer.
3.3.3 Stock Rotation— The principle of first in, first out, is recommended.
3.3.4 Store implants in the operating room in such a manner as to isolate and protect the implant’s surface, sterility, and
configuration. Keep implants made of different metals separated.
3.3.5 Store the implants and instruments in the operating room in such a manner as to isolate the instruments from the implants.
4. Handling
4.1 Mixing Metals— Maintain orthopedic implants and instruments of different metals separately to avoid the possibility of
mixing during surgery.
1
This practice is under the jurisdiction ofASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.21
on Osteosynthesis.
Current edition approved Apr. 10, 2003. Published June 2003. Originally approved in 1978. Last previous edition approved in 2000 as F565–00.
Current edition approved April 1, 2009. Published April 2009. Originally approved in 1978. Last previous edition approved in 2004 as F 565 – 04.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F 565 – 04 (2009)
4.2 Cleaning and Sterilization :
4.2.1 Priortoinitialsterilizationandpromptlyfollowingeachsurgicalprocedure,thoroughlyandcarefullycleanallinstruments
and implants. Ultrasonic cleaners, mechanized washers, or hand scrubbing are suitable methods, if carefully done. The method
employed should be utilized to prevent impact, scratching, bending, or surface contact with any materials that might affect t
...