ASTM F565-04(2018)
(Practice)Standard Practice for Care and Handling of Orthopedic Implants and Instruments
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, 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.
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Designation: F565 − 04 (Reapproved 2018)
Standard Practice for
1
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
and packaging procedures.
3.2 Transport—Perform transport in a manner to preclude
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
standard.
3.3 Storage:
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
safety concerns, if any, associated with its use. It is the manner as to maintain the device’s surface finish or
configuration, or both.
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter- 3.3.2 Manyimplantsareidentifiedbyaserialorlotnumber,
mine the applicability of regulatory limitations prior to use. or both, on the package label, package insert, or surface of the
1.6 This international standard was developed in accor- device. Record these control numbers and retain for transfer to
dance with internationally recognized principles on standard- patient records, to facilitate inventory, stock rotation, medical
ization established in the Decision on Principles for the device reporting, and possible traceability to the manufacturer.
Development of International Standards, Guides and Recom- 3.3.3 Stock Rotation—The principle of first in, first out, is
mendations issued by the World Trade Organization Technical
recommended.
Barriers to Trade (TBT) Committee.
3.3.4 Storeimplantsintheoperatingroominsuchamanner
as to isolate and protect the implant’s surface, sterility, and
2. Terminology
configuration. Keep implants made of different metals sepa-
2.1 Definitions of Terms Specific to This Standard:
rated.
2.1.1 orthopedic implant—a device introduced by surgically
3.3.5 Store the implants and instruments in the operating
penetrating the skin or mucosa of the body with the intention
room in such a manner as to isolate the instruments from the
that it remain within or attached to the skeleton within the body
implants.
following the surgery. This device is referred to in this practice
as an “implant.”
4. Handling
2.1.2 orthopedic instrument—any cooperative device used
4.1 Mixing Metals—Maintain orthopedic implants and in-
during surgical procedures involving the implantation of or-
struments of different metals separately to avoid the possibility
thopedic implants. This device is referred to in this practice as
of mixing during surgery.
an “instrument.”
4.2 Cleaning and Sterilization:
1
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 Feb. 1, 2018. Published April 2018. Originally
washers, or hand scrubbing are suitable methods, if carefully
approved in 1978. Last previous edition approved in 2013 as F565 – 04 (2013).
DOI: 10.1520/F0565-04R18. 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
---------------------- Page: 1 ----------------------
F565 − 04 (2018)
impact, scratching, bending, or surface contact with any 4.4.
...
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 − 04 (Reapproved 2013) F565 − 04 (Reapproved 2018)
Standard Practice for
1
Care and Handling of Orthopedic Implants and Instruments
This standard is issued under the fixed designation F565; 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 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 safety, health, and healthenvironmental 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.
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.”
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.21
on Osteosynthesis.
Current edition approved Oct. 1, 2013Feb. 1, 2018. Published October 2013April 2018. Originally approved in 1978. Last previous edition approved in 20092013 as
F565 – 04 (2009)(2013).ε1. DOI: 10.1520/F0565-04R13.10.1520/F0565-04R18.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F565 − 04 (2018)
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 duri
...
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