ASTM F3395/F3395M-19
(Specification)Standard Specification for Neurosurgical Head Holder Devices
Standard Specification for Neurosurgical Head Holder Devices
SCOPE
1.1 This specification covers standards a manufacturer shall meet in the performance testing of neurosurgical head holder devices (skull clamps).
1.2 This specification covers neurosurgical head holder devices (skull clamps) made of metal (nonradiolucent) as well as neurosurgical head holder devices (skull clamps) made of plastic material (radiolucent).
1.3 This specification represents the best currently available test procedures and is a minimum safety and performance standard.
1.4 This specification covers only those neurosurgical head holders (skull clamps) intended for use on humans for neurosurgical and spinal clinical applications. This specification assumes the user is well trained in the procedures and use of these devices including selection of the correct device type and accessories.
1.5 This specification describes those devices commonly known as skull clamps and accessories, such as skull pins, attachments, and various adaptors.
1.6 This specification only describes head holder devices that provide rigid skeletal fixation of the skull by means of three skull pins that penetrate the outer surface or outer layers of the patient’s head during neurosurgical or spinal procedures (compare with Ref (1)).2 Two pins are typically located in a 2-pin rocker, whereas the force delivery component is equipped with a single pin.
1.7 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. The values given in parentheses are for information only.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
FIG. 1 Skull Clamp Device Achieving 3-Pin Rigid Fixation
FIG. 2 Skull Clamp System (Skull Clamp, Base Unit, Adaptor, and Skull Pins)
1.9 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
Relations
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: F3395/F3395M −19
Standard Specification for
1
Neurosurgical Head Holder Devices
ThisstandardisissuedunderthefixeddesignationF3395/F3395M;thenumberimmediatelyfollowingthedesignationindicatestheyear
of original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.
A superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope used independently of the other, and values from the two
systems shall not be combined. The values given in parenthe-
1.1 This specification covers standards a manufacturer shall
ses are for information only.
meet in the performance testing of neurosurgical head holder
1.8 This standard does not purport to address all of the
devices (skull clamps).
safety concerns, if any, associated with its use. It is the
1.2 This specification covers neurosurgical head holder
responsibility of the user of this standard to establish appro-
devices (skull clamps) made of metal (nonradiolucent) as well
priate safety, health, and environmental practices and deter-
as neurosurgical head holder devices (skull clamps) made of
mine the applicability of regulatory limitations prior to use.
plastic material (radiolucent).
1.9 This international standard was developed in accor-
1.3 Thisspecificationrepresentsthebestcurrentlyavailable
dance with internationally recognized principles on standard-
test procedures and is a minimum safety and performance
ization established in the Decision on Principles for the
standard.
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.4 This specification covers only those neurosurgical head
Barriers to Trade (TBT) Committee.
holders (skull clamps) intended for use on humans for neuro-
surgical and spinal clinical applications. This specification
2. Referenced Documents
assumes the user is well trained in the procedures and use of
3
thesedevicesincludingselectionofthecorrectdevicetypeand 2.1 ASTM Standards:
accessories. D638Test Method for Tensile Properties of Plastics
D695Test Method for Compressive Properties of Rigid
1.5 This specification describes those devices commonly
Plastics
known as skull clamps and accessories, such as skull pins,
D792Test Methods for Density and Specific Gravity (Rela-
attachments, and various adaptors.
tive Density) of Plastics by Displacement
1.6 This specification only describes head holder devices
F2052Test Method for Measurement of Magnetically In-
that provide rigid skeletal fixation of the skull by means of
duced Displacement Force on Medical Devices in the
three skull pins that penetrate the outer surface or outer layers
Magnetic Resonance Environment
of the patient’s head during neurosurgical or spinal procedures
F2119Test Method for Evaluation of MR Image Artifacts
2
(compare with Ref (1)). Two pins are typically located in a
from Passive Implants
2-pin rocker, whereas the force delivery component is
F2182Test Method for Measurement of Radio Frequency
equipped with a single pin.
Induced Heating On or Near Passive Implants During
1.7 The values stated in either SI units or inch-pound units Magnetic Resonance Imaging
are to be regarded separately as standard. The values stated in F2213Test Method for Measurement of Magnetically In-
each system are not necessarily exact equivalents; therefore, to duced Torque on Medical Devices in the Magnetic Reso-
ensure conformance with the standard, each system shall be nance Environment
F2503Practice for Marking Medical Devices and Other
Items for Safety in the Magnetic Resonance Environment
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee
F04.25 on Spinal Devices.
3
Current edition approved Sept. 1, 2019. Published October 2019. DOI: 10.1520/ For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F3395_F3395M-19. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
The boldface numbers in parentheses refer to a list of references at the end of Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3395/F3395M − 19
FIG. 1 Skull Clamp Device Achieving 3-Pin Rigid Fixation
FIG. 2 Skull Clamp System (Skull Clamp, Base Unit, Adaptor, and Skull Pins)
4
2.2 IEC Standards: 3.1.3 force delivery component—component of the neuro-
IEC 60601-1Medical electrical equi
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.