ASTM F565-21
(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.
General Information
- Status
- Published
- Publication Date
- 31-Mar-2021
- Technical Committee
- F04 - Medical and Surgical Materials and Devices
- Drafting Committee
- F04.21 - Osteosynthesis
Overview
ASTM F565-21, Standard Practice for Care and Handling of Orthopedic Implants and Instruments, provides comprehensive guidelines for the proper handling, storage, cleaning, and sterilization of orthopedic implants and related surgical instruments within healthcare facilities. The standard is essential for hospital receiving personnel, central supply teams, operating room staff, surgeons, and others involved in the care of orthopedic devices. By adhering to ASTM F565-21, institutions can prevent damage, ensure device integrity, and support patient safety throughout the perioperative process.
Key Topics
- Receiving and Initial Handling
- Implants are often delivered in sterilizable or pre-sterilized packaging. Staff should not remove these wrappings upon receipt.
- For non-sterilized implants and instruments, careful handling is mandated to avoid scratches, impacts, or abrasions.
- Transport
- Devices must be transported in a manner that avoids damage or alteration from their original state.
- Storage
- Implants and instruments should be stored so their surface finish and configuration remain intact.
- Follow the principle of "first in, first out" for stock rotation.
- Keep orthopedic devices made from different metals separate to prevent cross-contamination.
- Ensure serial numbers or unique identifiers remain legible after cleaning and sterilization processes.
- Cleaning and Sterilization
- Instruments and implants require thorough cleaning prior to initial sterilization and directly after each use.
- Utilize appropriate cleaning techniques such as ultrasonic cleaners, mechanized washers, or manual scrubbing with soft brushes.
- Rinse all devices thoroughly to remove cleaning residues, and dry them carefully, paying attention to hinges and recesses.
- Lubricate instruments as directed by the manufacturer.
- Sterilize according to manufacturer guidelines, using methods that maintain integrity and avoid interaction between different materials.
- Inspection and Reuse
- Dispose of implants or instruments that are visibly damaged or have compromised performance.
- Avoid reimplanting devices that have previously been implanted in other patients.
- Documentation
- Maintain accurate records of device identification numbers for each patient to aid in traceability and inventory management.
Applications
ASTM F565-21 is widely used in hospital environments to establish best practices for the handling of orthopedic implants and surgical instruments. Some practical applications include:
- Training hospital staff in correct handling to minimize damage and ensure device sterility.
- Implementing standardized operating procedures for receiving, storing, and preparing implants before surgery.
- Supporting quality assurance initiatives and compliance with regulatory requirements by maintaining comprehensive device traceability.
- Ensuring patient safety by reducing the risk of contamination and device failure due to improper care or handling.
- Helping surgical teams manage a diverse inventory of orthopedic devices efficiently while minimizing risk.
Related Standards
Organizations seeking to maintain compliance and high standards in orthopedic device handling may also consult:
- ASTM F04 Series: Additional standards on medical and surgical materials and devices.
- ASTM F138: Standard Specification for Stainless Steel Bars and Wire for Surgical Implants.
- ISO 17664: Instructions for the processing of medical devices.
- AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.
Careful adherence to ASTM F565-21 and related standards fosters optimal outcomes for orthopedic procedures, while safeguarding the quality and safety of implants and surgical instruments throughout their lifecycle.
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Frequently Asked Questions
ASTM F565-21 is a standard published by ASTM International. Its full title is "Standard Practice for Care and Handling of Orthopedic Implants and Instruments". This standard covers: 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.
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.
ASTM F565-21 is classified under the following ICS (International Classification for Standards) categories: 11.040.30 - Surgical instruments and materials; 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F565-21 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
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.
Designation: F565 − 21
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
1.2 Hospital receiving personnel, central supply personnel,
pre-sterilized packages, envelopes, or other containers. These
operating room personnel, surgeons, and occasionally other
wrappings should not be removed by the receiving personnel.
individuals will handle orthopedic implants and instruments.
3.1.2 Carefully unwrap and handle non-sterilized implants
All personnel should be informed of recommended care and
and instruments upon receipt to avoid scratching, marking, or
handling procedures to prevent damage to orthopedic implants
abrasion by other implants, instruments, unpacking tools, or by
and instruments.
dropping or otherwise endangering the surface finish or con-
1.3 Thispracticedoesnotcoverproducerlevelhandlingand figuration.
packaging procedures.
3.2 Transport—Perform transport in such a manner as to
1.4 The values stated in SI units are to be regarded as
preclude any damage or alteration to the received condition of
standard. No other units of measurement are included in this
the implant or instrument.
standard.
3.3 Storage:
1.5 This standard does not purport to address all of the
3.3.1 Store implants or instruments prior to use in such a
safety concerns, if any, associated with its use. It is the
manner as to maintain the device’s surface finish or
responsibility of the user of this standard to establish appro-
configuration, or both.
priate safety, health, and environmental practices and deter-
3.3.2 Many implants and instruments are identified by a
mine the applicability of regulatory limitations prior to use.
serial number, lot number, Unique Device Identification (UDI),
1.6 This international standard was developed in accor-
or a data matrix on the package label, package insert, or surface
dance with internationally recognized principles on standard-
of the device. Record these control numbers from implants and
ization established in the Decision on Principles for the
retain for transfer to patient records to facilitate inventory,
Development of International Standards, Guides and Recom-
stock rotation, medical device reporting, and possible trace-
mendations issued by the World Trade Organization Technical
ability to the manufacturer. If it is a reusable device, verify that
Barriers to Trade (TBT) Committee.
the device identification number (serial number, lot number,
2. Terminology
UDI, or data matrix) on the surface of the device is legible after
2.1 Definitions of Terms Specific to This Standard: cleaning/sterilization cycles prior to storing.
2.1.1 orthopedic implant—a device introduced by surgically
3.3.3 Stock Rotation—The principle of first in, first out, is
penetrating the skin or mucosa of the body with the intention
recommended.
that it remain within or attached to the skeleton within the body
3.3.4 Store implants in the operating room in such a manner
following the surgery. This device is referred to in this practice
as to isolate and protect the implant’s surface, sterility, and
as an “implant.”
configuration. Keep implants made of different metals sepa-
2.1.2 orthopedic instrument—any cooperative device used
rated.
during surgical procedures involving the implantation of or-
3.3.5 Store the implants and instruments in the operating
thopedic implants. This device is referred to in this practice as
room in such a manner as to isolate the instruments from the
an “instrument.”
implants.
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
4. Handling
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.21 on Osteosynthesis.
4.1 Separating Metals—Maintain orthopedic implants and
Current edition approved April 1, 2021. Published April 2021. Originally
instruments of different metals separately to avoid the possi-
approved in 1978. Last previous edition approved in 2018 as F565 – 04 (2018).
DOI: 10.1520/F0565-21. bility of mixing during surgery.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F565 − 21
4.2 Cleaning and Sterilization: 4.4 Contouring and Modifying Implants and Instruments:
4.4.1 Contouring or clamping of orthopedic implants, when
4.2.1 Prior to initial sterilization and promptly following
necessary, shall be performed by the surgeon in a manner that
each surgical proce
...
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 2018) F565 − 21
Standard Practice for
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 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.
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.
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 Feb. 1, 2018April 1, 2021. Published April 2018April 2021. Originally approved in 1978. Last previous edition approved in 20132018 as
F565 – 04 (2013).(2018). DOI: 10.1520/F0565-04R18.10.1520/F0565-21.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F565 − 21
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 such a manner as 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 and instruments are identified by a serial ornumber, lot number, or both, Unique Device Identification (UDI),
or a data matrix on the package label, package insert, or surface of the device. Record these control numbers from implants and
retain for transfer to patient records,records to facilitate inventory, stock rotation, medical device reporting, and possible
traceability to the manufacturer. If it is a reusable device, verify that the device identification number (serial number, lot number,
UDI, or data matrix) on the surface of the device is legible after cleaning/sterilization cycles prior to storing.
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 MixingSeparating Metals—Maintain orthopedic implants and instruments of different metals separately to avoid the possibility
of mixing during surgery.
F565 − 21
4.2 Cleaning and Sterilization:
4.2.1 Prior to initial sterilization and promptly following each surgical procedure, thoroughly and carefully clean all instrum
...
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