ASTM F565-04(2009)e1

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: 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(2009) - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• Effective Date: 01-Apr-2009
• Replaced By: ASTM F565-04(2013) - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• Effective Date: 01-Oct-2013
• 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
´1
Designation: F565 − 04(Reapproved 2009)
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.
´ NOTE—Units information was editorially corrected in August 2009.
1. Scope 3.1.1 Many implants are wrapped in special sterilizable or
pre-sterilized packages, envelopes, or other containers. These
1.1 This practice covers recommended procedures for the
wrappings should not be removed by the receiving personnel.
handling of orthopedic implants and instruments.
3.1.2 Carefully unwrap and handle non-sterilized implants
1.2 Hospital receiving personnel, central supply personnel,
and instruments upon receipt to avoid scratching, marking, or
operating room personnel, surgeons, and occasionally other
abrasion by other implants, instruments, unpacking tools, or by
individuals will handle orthopedic implants and instruments.
dropping or otherwise endangering the surface finish or con-
All personnel should be informed of recommended care and
figuration.
handling procedures to prevent damage to orthopedic implants
3.2 Transport—Perform transport in a manner to preclude
and instruments.
any damage or alteration to the received condition of the
1.3 This practice does not cover producer level handling
implant or instrument.
and packaging procedures.
3.3 Storage:
1.4 The values stated in SI units are to be regarded as
3.3.1 Store implants or instruments prior to use in such a
standard. No other units of measurement are included in this
manner as to maintain the device’s surface finish or
standard.
configuration, or both.
1.5 This standard does not purport to address all of the
3.3.2 Manyimplantsareidentifiedbyaserialorlotnumber,
safety concerns, if any, associated with its use. It is the
or both, on the package label, package insert, or surface of the
responsibility of the user of this standard to establish appro-
device. Record these control numbers and retain for transfer to
priate safety and health practices and determine the applica-
patient records, to facilitate inventory, stock rotation, medical
bility of regulatory limitations prior to use.
device reporting, and possible traceability to the manufacturer.
3.3.3 Stock Rotation—The principle of first in, first out, is
2. Terminology
recommended.
2.1 Definitions of Terms Specific to This Standard:
3.3.4 Storeimplantsintheoperatingroominsuchamanner
2.1.1 orthopedic implant—a device introduced by surgically
as to isolate and protect the implant’s surface, sterility, and
penetrating the skin or mucosa of the body with the intention
configuration. Keep implants made of different metals sepa-
that it remain within or attached to the skeleton within the body
rated.
following the surgery. This device is referred to in this practice
3.3.5 Store the implants and instruments in the operating
as an “implant.”
room in such a manner as to isolate the instruments from the
2.1.2 orthopedic instrument—any cooperative device used
implants.
during surgical procedures involving the implantation of or-
thopedic implants. This device is referred to in this practice as
4. Handling
an “instrument.”
4.1 Mixing Metals—Maintain orthopedic implants and in-
3. Receiving Implants and Instruments
struments of different metals separately to avoid the possibility
of mixing during surgery.
3.1 Receipt:
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 April 1, 2009. Published April 2009. Originally
washers, or hand scrubbing are suitable methods, if carefully
approved in 1978. Last previous edition approved in 2004 as F565 – 04. DOI:
10.1520/F0565-04R09E01. 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
´1
F565 − 04 (2009)
impact, scratching, bending, or surface contact with any 4.4.2 It is recommended that metall
...

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.
´1
Designation: F 565 – 04 (Reapproved 2009)
Standard Practice for
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.
´ NOTE—Units information was editorially corrected in August 2009.
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 ofto orthopedic implants and instruments.
1.3 This practice does not cover producer level handling and packaging procedures.
1.4
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.
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.
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 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
F 565 – 04 (2009)
4. Handling
4.1 Mixing Metals—Maintain orthopedic implants and instruments of different metals separately to avoid the possibility of
mixing during surgery.
4.2 Cleaning and Sterilization :
4.2.1 Priortoinitialsterilizationandpromptlyfollowingeachsurgicalprocedure,thoroughlyandcarefullycleanallinstruments
and implants. Ultrasonic cleaners, mechanized washers,
...