ASTM F700-93(2022)

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.  
1.4 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-2022
• 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)

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: F700 − 93 (Reapproved 2022)
Standard Practice for
Care and Handling of Intracranial Aneurysm Clips and
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 3.1.1 Many implants are wrapped in special packages,
envelopes, or other containers. These wrappings should not be
1.1 This practice covers recommended procedures for han-
removed by the receiving personnel.
dling of neurosurgical intracranial aneurysm clips and the clip
3.1.2 Carefully handle nonsterilized implants and instru-
appliers (instruments).
ments upon receipt to avoid scratching, marking, or abrasion
1.2 This practice is intended to inform hospital receiving
by other implants, instruments, unpacking tools, or by drop-
personnel, central supply personnel, operating room personnel,
ping or otherwise endangering the surface finish or configura-
and other individuals who will handle intracranial aneurysm
tion.
clips and the instruments related thereto of recommended care
3.2 Transport—Transport in a manner to preclude any
and handling procedures to prevent damage of intracranial
damage or alteration to the received condition of the implant or
aneurysm clips and instruments.
instrument (clip applier).
1.3 Handling and packaging procedures for the product are
3.3 Storage:
not a part of this practice and are covered in other practices.
3.3.1 Store the aneurysm clips and appliers prior to use in
1.4 This international standard was developed in accor-
such a manner to maintain the device’s surface finish or
dance with internationally recognized principles on standard-
configuration, or both.
ization established in the Decision on Principles for the
3.3.2 Implants will be identified by a unique code on the
Development of International Standards, Guides and Recom-
surface of the device. When implanted, it is necessary that the
mendations issued by the World Trade Organization Technical
type of aneurysm clip and its code be noted in the operative
Barriers to Trade (TBT) Committee.
report.
3.3.3 Stock Rotation—The principle of first in, first out, is
2. Terminology
recommended.
3.3.4 Store implants in the operating room in such a manner
2.1 Definitions:
as to isolate and protect the implant’s surface, sterility, and
2.1.1 clip applier—any clip holder designed specifically for
configuration. Keep implants made of different metals sepa-
a particular type clip used during surgical procedures involving
rated.
the implantation of intracranial aneurysm clips. This device is
referred to in this practice as a clip applier.
4. Cleaning and Sterilization
2.1.2 intracranial aneurysm clip—a device introduced sur-
4.1 Prior to resterilization and promptly following each
gically to occlude the blood inlet into an intracranial aneurysm
surgical procedure, thoroughly and carefully clean all instru-
with the intention that it remain within the body following the
ments and implants with approved cleaning techniques. Ultra-
surgery. This device is referred to in this practice as an
sonic cleaners or hand scrubbing are suitable methods if
“implant,” specifically as an intracranial aneurysm clip.
carefully done. The method employed should be utilized to
prevent impact, scratching, bending, or surface contact with
3. Receiving Implants and Instruments
any materials that might affect the implant or instrument
3.1 Receipt: 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 an
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