ASTM F701-81(2008)

Standard Practice for Care and Handling of Neurosurgical Implants and Instruments (Withdrawn 2017)

SCOPE
1.1 This practice covers recommended procedures for handling neurosurgical implants and instruments.
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle neurosurgical implants and instruments of recommended care and handling procedures to prevent damage of neurosurgical implants and instruments.
WITHDRAWN RATIONALE
This practice covered recommended procedures for handling neurosurgical implants and instruments.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this practice was withdrawn in July 2017 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

• Status: Withdrawn
• Publication Date: 31-Jan-2008
• Withdrawal Date: 16-Jul-2017
• 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: F04.31 - Neurosurgical Standards

Relations

• Replaces: ASTM F701-81(2002) - Standard Practice for Care and Handling of Neurosurgical Implants and Instruments
• Effective Date: 01-Feb-2008

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F701 − 81 (Reapproved 2008)
Standard Practice for
Care and Handling of Neurosurgical Implants and
Instruments
ThisstandardisissuedunderthefixeddesignationF701;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 3.3 Storage:
3.3.1 Store implants or instruments prior to use in such a
1.1 This practice covers recommended procedures for han-
manner as to maintain the device’s surface finish or
dling neurosurgical implants and instruments.
configuration, or both.
1.2 This practice is intended to inform hospital receiving
3.3.2 Many implants are identified by a serial or lot number,
personnel, central supply personnel, operating room personnel,
or both, on the package label, package insert, or surface of the
and other individuals who will handle neurosurgical implants
device. Record these control numbers and retain for transfer to
and instruments of recommended care and handling procedures
patient records to facilitate inventory, stock rotation, and
to prevent damage of neurosurgical implants and instruments.
possible traceability to the manufacturer.
3.3.3 Stock Rotation—The principle of first in, first out is
2. Terminology
recommended.
2.1 Definitions:
3.3.4 Store implants in the operating room in such a manner
2.1.1 neurosurgical implant—for the purpose of this
as to isolate and protect the implant’s surface, sterility, and
practice, a device introduced by surgically penetrating the skin
configuration. Keep implants made of different metals sepa-
or mucosa of the body with the intention that it remain
rated.
indefinitely within the body following surgery. This device is
3.3.5 Store the implants and instruments in the operating
referred to in this practice as an “implant.”
room in such a manner as to isolate the instruments from the
2.1.2 neurosurgical instrument—any cooperative device
implants.
used during surgical procedures involving the implantation of
3.3.6 Mixing Metals—Maintain neurosurgical implants and
neurosurgical implants. This device is referred to in this
instruments of different metals separately to avoid the possi-
practice as an “instrument.”
bility of mixing during surgery.
3. Receiving Implants and Instruments
4. Cleaning and Sterilization
3.1 Receipt:
4.1 Prior to initial sterilization and promptly following each
3.1.1 Many implants are wrapped in special sterilizable or
surgical procedure, thoroughly and carefully clean all instru-
presterilized packages, envelopes, or other containers. These
ments and implants. Ultrasonic cleaners, mechanized washers,
wrappings should not be removed by the personnel who
or hand scrubbing are suitable methods if carefully done. The
receive the packages.
method employed should be utilized to prevent impact,
3.1.2 Carefully unwrap and handle nonsterilized implants
scratching, bending, or surface contact with any materials that
and instruments upon receipt in such a manner to avoid
might affect the implant or instrument surface or configuration.
scratching, marking, or abrasion by other implants,
4.2 Closely follow the manufacturer’s recommendations on
instruments, unpackaging tools, or by such mishaps as drop-
cleaning. In hand scrubbing, use soft brushes and avoid harsh
ping or otherwise endangering the surface finish or configura-
chemicals or harsh cleaning solutions.
tion.
4.3 After cleaning, rinse the neurosurgical implants and
3.2 Transport—Transport in a manner to preclude any
instruments completely fre
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