ASTM F700-93(2022)
(Practice)Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments
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
- Technical Committee
- F04 - Medical and Surgical Materials and Devices
- Drafting Committee
- F04.31 - Neurosurgical Standards
Overview
ASTM F700-93(2022), Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments, provides comprehensive guidelines for the safe handling and maintenance of neurosurgical intracranial aneurysm clips and their associated instruments, such as clip appliers. This international standard is essential for hospital staff who are involved in the receipt, storage, cleaning, sterilization, and operational use of these critical neurosurgical devices. By adhering to ASTM F700-93, healthcare facilities can help ensure the integrity, performance, and safety of intracranial aneurysm clips and instruments used in neurosurgical procedures.
Key Topics
- Personnel Guidance: The standard is directed at receiving, central supply, and operating room personnel who handle intracranial aneurysm clips and clip appliers.
- Handling Recommendations: Emphasizes careful handling of non-sterilized implants and instruments to prevent scratching, marking, or other damage.
- Receiving Protocols:
- Do not remove specialty packaging upon receipt.
- Handle all products with care to maintain their surface finish and configuration.
- Storage Requirements:
- Maintain separation by material type and code for accurate tracking.
- Use the first-in, first-out principle to reduce storage time and risk of deterioration.
- Store in a way that maintains sterility, surface integrity, and device shape.
- Cleaning and Sterilization:
- Clean thoroughly after each use using appropriate, approved techniques (e.g., ultrasonic cleaners or gentle hand scrubbing).
- Avoid procedures that may impact, scratch, or otherwise compromise the device.
- Rinse fully to remove residue and dry thoroughly, focusing on hinges and recesses.
- Lubricate only clip appliers as recommended by the manufacturer.
- Sterilize with care, ensuring different materials do not come into contact during the process.
- Device Use and Reuse:
- Clips must be operated only with their specific applier - never opened by hand.
- Do not reuse any clip that has been implanted or in contact with blood/fluid but unused.
- Discard any clips that have been damaged, have altered performance, or were opened with fingers.
Applications
- Hospitals and Surgical Centers: Ensures consistent standards for the care and handling of intracranial aneurysm clips and related instruments throughout the clinical environment.
- Central Supply and Sterile Processing: Guides central supply departments in developing protocols for storage, cleaning, and sterilization, reducing instrument damage and risk of device failure.
- Neurosurgical Procedures: Promotes patient safety by minimizing the risk of implant malfunction due to improper handling or contamination.
- Inventory Management: Supports traceability of implants with guidelines on unique device codes and encourages best practices in stock rotation.
Adherence to ASTM F700-93 helps protect patients and supports hospital compliance with internationally recognized medical device handling standards.
Related Standards
- ASTM F561 - Standard Practice for Retrieval and Analysis of Medical Devices, Implants, and Explanted Tissue.
- ASTM F86 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants.
- ISO 17665 - Sterilization of Health Care Products - Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices.
- AAMI ST79 - Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.
Keywords: Intracranial aneurysm clips, neurosurgical instruments, sterile processing, care and handling, ASTM F700, cleaning neurosurgical devices, surgical implant safety, healthcare sterilization standards.
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Frequently Asked Questions
ASTM F700-93(2022) is a standard published by ASTM International. Its full title is "Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments". This standard covers: 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.
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.
ASTM F700-93(2022) is classified under the following ICS (International Classification for Standards) categories: 11.040.30 - Surgical instruments and materials. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F700-93(2022) is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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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