ASTM F565-00(2003)

Standard Practice for Care and Handling of Orthopedic Implants and Instruments

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: 09-Apr-2003
• 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 F565-00 - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• Effective Date: 10-Apr-2003
• Replaced By: ASTM F565-04 - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• Effective Date: 01-Oct-2004
• Referred By: ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• Effective Date: 10-Apr-2003
• 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: 10-Apr-2003
• Referred By: ASTM F382-17 - Standard Specification and Test Method for Metallic Bone Plates
• Effective Date: 10-Apr-2003
• Referred By: ASTM F1264-16e1 - Standard Specification and Test Methods for Intramedullary Fixation Devices
• Effective Date: 10-Apr-2003
• 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: 10-Apr-2003
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 10-Apr-2003
• Referred By: ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2884-21 - Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation of Spinal Fusion
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 10-Apr-2003
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 10-Apr-2003
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 10-Apr-2003
• Referred By: ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 10-Apr-2003
• Referred By: ASTM F1611-20 - Standard Specification for Intramedullary Reamers
• Effective Date: 10-Apr-2003

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: F 565 – 00 (Reapproved 2003)
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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope abrasion by other implants, instruments, unpacking tools, or by
dropping or otherwise endangering the surface finish or con-
1.1 This practice covers recommended procedures for the
figuration.
handling of orthopedic implants and instruments.
3.2 Transport—Perform transport in a manner to preclude
1.2 Hospital receiving personnel, central supply personnel,
any damage or alteration to the received condition of the
operating room personnel, surgeons, and occasionally other
implant or instrument.
individuals will handle orthopedic implants and instruments.
3.3 Storage:
All personnel should be informed of recommended care and
3.3.1 Store implants or instruments prior to use in such a
handling procedures to prevent damage of orthopedic implants
manner as to maintain the device’s surface finish or configu-
and instruments.
ration, or both.
1.3 This practice does not cover producer level handling
3.3.2 Many implants are identified by a serial or lot number,
and packaging procedures.
or both, on the package label, package insert, or surface of the
1.4 This standard does not purport to address all of the
device. Record these control numbers and retain for transfer to
safety concerns, if any, associated with its use. It is the
patient records, to facilitate inventory, stock rotation, medical
responsibility of the user of this standard to establish appro-
device reporting, and possible traceability to the manufacturer.
priate safety and health practices and determine the applica-
3.3.3 Stock Rotation—The principle of first in, first out, is
bility of regulatory limitations prior to use.
recommended.
2. Terminology 3.3.4 Store implants in the operating room in such a manner
as to isolate and protect the implant’s surface, sterility, and
2.1 Definitions of Terms Specific to This Standard:
configuration. Keep implants made of different metals sepa-
2.1.1 orthopedic implant—a device introduced by surgically
rated.
penetrating the skin or mucosa of the body with the intention
3.3.5 Store the implants and instruments in the operating
that it remain within or attached to the skeleton within the body
room in such a manner as to isolate the instruments from the
following the surgery. This device is referred to in this practice
implants.
as an “implant.”
2.1.2 orthopedic instrument—any cooperative device used
4. Handling
during surgical procedures involving the implantation of or-
4.1 Mixing Metals—Maintain orthopedic implants and in-
thopedic implants. This device is referred to in this practice as
struments of different metals separately to avoid the possibility
an “instrument.”
of mixing during surgery.
3. Receiving Implants and Instruments 4.2 Cleaning and Sterilization:
4.2.1 Prior to initial sterilization and promptly following
3.1 Receipt:
each surgical procedure, thoroughly and carefully clean all
3.1.1 Many implants are wrapped in special sterilizable or
instruments and implants. Ultrasonic cleaners, mechanized
pre-sterilized packages, envelopes, or other containers. These
washers, or hand scrubbing are suitable methods, if carefully
wrappings should not be removed by the receiving personnel.
done. The method employed should be utilized to prevent
3.1.2 Carefully unwrap and handle non-sterilized implants
impact, scratching, bending, or surface contact with any
and instruments upon receipt to avoid scratching, marking, or
materials that might affect the implant or instrument surface or
configuration.
4.2.2 Closely follow the manufacturer’s recommendations
This practice is under the jurisdiction of ASTM Committee F04 on Medical and
on cleaning. In hand scrubbing, use soft brushes and avoid
Surgical Materials and Devices and is the direct resp
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