ASTM F700-93(2014)

Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments

SCOPE
1.1 This practice covers recommended procedures for handling of neurosurgical intracranial aneurysm clips and the clip appliers (instruments).  
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and other individuals who will handle intracranial aneurysm clips and the instruments related thereto of recommended care and handling procedures to prevent damage of intracranial aneurysm clips and instruments.  
1.3 Handling and packaging procedures for the product are not a part of this practice and are covered in other practices.

General Information

• Status: Historical
• Publication Date: 30-Sep-2014
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.31 - Neurosurgical Standards

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F700 − 93 (Reapproved 2014)
Standard Practice for
Care and Handling of Intracranial Aneurysm Clips and
1
Instruments
ThisstandardisissuedunderthefixeddesignationF700;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 3.2 Transport—Transport in a manner to preclude any
damage or alteration to the received condition of the implant or
1.1 This practice covers recommended procedures for han-
instrument (clip applier).
dling of neurosurgical intracranial aneurysm clips and the clip
appliers (instruments).
3.3 Storage:
3.3.1 Store the aneurysm clips and appliers prior to use in
1.2 This practice is intended to inform hospital receiving
such a manner to maintain the device’s surface finish or
personnel, central supply personnel, operating room personnel,
configuration, or both.
and other individuals who will handle intracranial aneurysm
3.3.2 Implants will be identified by a unique code on the
clips and the instruments related thereto of recommended care
surface of the device. When implanted, it is necessary that the
and handling procedures to prevent damage of intracranial
type of aneurysm clip and its code be noted in the operative
aneurysm clips and instruments.
report.
1.3 Handling and packaging procedures for the product are
3.3.3 Stock Rotation—The principle of first in, first out, is
not a part of this practice and are covered in other practices.
recommended.
3.3.4 Store implants in the operating room in such a manner
2. Terminology
as to isolate and protect the implant’s surface, sterility, and
2.1 Definitions:
configuration. Keep implants made of different metals sepa-
2.1.1 clip applier—any clip holder designed specifically for
rated.
a particular type clip used during surgical procedures involving
the implantation of intracranial aneurysm clips. This device is
4. Cleaning and Sterilization
referred to in this practice as a clip applier.
4.1 Prior to resterilization and promptly following each
2.1.2 intracranial aneurysm clip—a device introduced sur-
surgical procedure, thoroughly and carefully clean all instru-
gically to occlude the blood inlet into an intracranial aneurysm
ments and implants with approved cleaning techniques. Ultra-
with the intention that it remain within the body following the
sonic cleaners or hand scrubbing are suitable methods if
surgery. This device is referred to in this practice as an
carefully done. The method employed should be utilized to
“implant,” specifically as an intracranial aneurysm clip.
prevent impact, scratching, bending, or surface contact with
3. Receiving Implants and Instruments any materials that might affect the implant or instrument
configuration. Aneurysm clips must not be opened except by
3.1 Receipt:
their specific applier.
3.1.1 Many implants are wrapped in special packages,
envelopes, or other containers. These wrappings should not be
4.2 Any clip that has been implanted or in direct contact
removed by the receiving personnel. with blood or body fluids and is not used in the procedure
3.1.2 Carefully handle nonsterilized implants and instru-
should not be reused in any subsequent procedure. The clips
ments upon receipt to avoid scratching, marking, or abrasion should be discarded; in accordance with tracing requirements,
by other implants, instruments, unpacking tools, or by drop-
the manufacturer must be informed of each clip that is
ping or otherwise endangering the surface finish or configura- discarded.
tion.
4.3 After cleaning, rinse the neurosurgical intracranial an-
eurysm clips and instruments completely free of all residuals
1
including soap, detergent, or cleaning solutions; and dry
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
thoroughly. Devote special attention to hinges on the instru-
F04.31 on Neurosurgical Standards.
ments and recesses on the clips since these are points that
Current edition approved Oct. 1, 2014. Published November 2014. Originally
entrap both chemicals and rinse water. In so doing, the clip
approved in 1981. Last previous edition approved in 2008 as F700 – 93 (2008).
DOI: 10.1520/F0700-93R14. must not be opened except by its designated applier.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F700 − 93 (2014)
4.4 Lubricate clip appliers that require lubrication immedi- 5.1.1 Any aneurysm clip that has been opened with the
ately after drying. Follow the recommendations of the manu- finge
...

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: F700 − 93 (Reapproved 2008) F700 − 93 (Reapproved 2014)
Standard Practice for
Care and Handling of Intracranial Aneurysm Clips and
1
Instruments
This standard is issued under the fixed designation F700; 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 handling of neurosurgical intracranial aneurysm clips and the clip appliers
(instruments).
1.2 This practice is intended to inform hospital receiving personnel, central supply personnel, operating room personnel, and
other individuals who will handle intracranial aneurysm clips and the instruments related thereto of recommended care and
handling procedures to prevent damage of intracranial aneurysm clips and instruments.
1.3 Handling and packaging procedures for the product are not a part of this practice and are covered in other practices.
2. Terminology
2.1 Definitions:
2.1.1 clip applier—any clip holder designed specifically for a particular type clip used during surgical procedures involving the
implantation of intracranial aneurysm clips. This device is referred to in this practice as a clip applier.
2.1.2 intracranial aneurysm clip—a device introduced surgically to occlude the blood inlet into an intracranial aneurysm with
the intention that it remain within the body following the surgery. This device is referred to in this practice as an “implant,”
specifically as an intracranial aneurysm clip.
3. Receiving Implants and Instruments
3.1 Receipt:
3.1.1 Many implants are wrapped in special packages, envelopes, or other containers. These wrappings should not be removed
by the receiving personnel.
3.1.2 Carefully handle nonsterilized 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—Transport in a manner to preclude any damage or alteration to the received condition of the implant or
instrument (clip applier).
3.3 Storage:
3.3.1 Store the aneurysm clips and appliers prior to use in such a manner to maintain the device’s surface finish or configuration,
or both.
3.3.2 Implants will be identified by a unique code on the surface of the device. When implanted, it is necessary that the type
of aneurysm clip and its code be noted in the operative report.
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.
4. Cleaning and Sterilization
4.1 Prior to resterilization and promptly following each surgical procedure, thoroughly and carefully clean all instruments and
implants with approved cleaning techniques. Ultrasonic cleaners or hand scrubbing are suitable methods if carefully done. The
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 F04.31
on Neurosurgical Standards.
Current edition approved Feb. 1, 2008Oct. 1, 2014. Published March 2008November 2014. Originally approved in 1981. Last previous edition approved in 20022008 as
F700 – 93 (2002).(2008). DOI: 10.1520/F0700-93R08.10.1520/F0700-93R14.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F700 − 93 (2014)
method employed should be utilized to prevent impact, scratching, bending, or surface contact with any materials that might affect
the implant or instrument configuration. Aneurysm clips must not be opened except by their specific applier.
4.2 Any clip that has been implanted or in direct contact with blood or body fluids and is not used in the procedure should not
be reused in any subsequent procedure. The clips should be discarded; in accordance with tracing requirements, the manufacturer
must be informed of each clip that is discarded.
4.3 After cleaning, rinse the neurosurgical intracranial aneurysm clips and instruments completely free of all residuals including
soap, detergent, or cleaning solutions; and dry thoroughly. Devote special attention to hinges on
...