ASTM F701-81(1998)

NOTICE: This standard has either been superseded and replaced by a new version or
withdrawn.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 701 – 81 (Reapproved 1998)
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Practice for
Care and Handling of Neurosurgical Implants and
Instruments
This standard is issued under the fixed designation F 701; 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 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
1.1 This practice covers recommended procedures for han-
device. Record these control numbers and retain for transfer to
dling neurosurgical implants and instruments.
patient records to facilitate inventory, stock rotation, and
1.2 This practice is intended to inform hospital receiving
possible traceability to the manufacturer.
personnel, central supply personnel, operating room personnel,
3.3.3 Stock Rotation—The principle of first in, first out is
and other individuals who will handle neurosurgical implants
recommended.
and instruments of recommended care and handling procedures
3.3.4 Store implants in the operating room in such a manner
to prevent damage of neurosurgical implants and instruments.
as to isolate and protect the implant’s surface, sterility, and
2. Terminlogy configuration. Keep implants made of different metals sepa-
rated.
2.1 Definitions:
3.3.5 Store the implants and instruments in the operating
2.1.1 neurosurgical implant—for the purpose of this prac-
room in such a manner as to isolate the instruments from the
tice, a device introduced by surgically penetrating the skin or
implants.
mucosa of the body with the intention that it remain indefi-
3.3.6 Mixing Metals—Maintain neurosurgical implants and
nitely within the body following surgery. This device is
instruments of different metals separately to avoid the possi-
referred to in this practice as an “implant.”
bility of mixing during surgery.
2.1.2 neurosurgical instrument—any cooperative device
used during surgical procedures involving the implantation of
4. Cleaning and Sterilization
neurosurgical implants. This device is referred to in this
4.1 Prior to initial sterilization and promptly following each
practice as an “instrument.”
surgical procedure, thoroughly and carefully clean all instru-
3. Receiving Implants and Instruments
ments and implants. Ultrasonic cleaners, mechanized washers,
or hand scrubbing are suitable methods if carefully done. The
3.1 Receipt:
method employed should be utilized to prevent impact,
3.1.1 Many implants are wrapped in special sterilizable or
scratching, bending, or surface contact with any materials that
presterilized packages, envelopes, or other containers. These
might affect the implant or instrument surface or configuration.
wrappings should not be removed by the personnel who
4.2 Closely follow the manufacturer’s recommendations on
receive the packages.
cleaning. In hand scrubbing, use soft brushes and avoid harsh
3.1.2 Carefully unwrap and handle nonsterilized implants
chemicals or harsh cleaning solutions.
and instruments upon receipt in such a manner to avoid
4.3 After cleaning, rinse the neurosurgical implants and
scratching, marking, or abrasion by other implants, instr
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