ASTM F647-94(2006)
(Practice)Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
SIGNIFICANCE AND USE
This practice provides minimum requirements for the ensurance of safety and efficacy. It provides a common language whereby the function of these surgical implants is described.
SCOPE
1.1 This practice covers requirements for the evaluation and specification of implantable shunts as related to resistance to flow, direction of flow, materials, radiopacity, mechanical properties, finish, sterility, and labeling of shunt assemblies.
1.2 Devices to which this practice is applicable include, but are not limited to, those that are temporarily implanted to effect external drainage; or permanently implanted to effect shunting of fluid from a cerebral ventricle, a cyst, the subarachnoid space to the peritoneal cavity, the venous circulation, or some other suitable internal delivery site, and intracranial bypass.
1.3 Limitations Although this practice includes a standard test method for the evaluation of pressure/flow characteristics of shunts or shunt components, it does not include specific pressure/flow requirements.
1.4 The following components, that individually or in combination comprise shunt assemblies, are considered to be within the scope of this practice: catheters (such as atrial, peritoneal, ventricular), connectors, implantable accessory devices (such as antisiphon devices and reservoirs), valved catheters and valves.
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 and health practices and determine the applicability of regulatory limitations prior to use.Note 1
The following standards contain provisions that, through reference in this text, constitute provisions of this practice. At the time of publication, the editions indicated are valid. All standards are subject to revision, and parties to agreements based on this practice are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Devices or components, or both, whose structures are comparable to that outlined in these standards are acceptable.
1.5 This test method provides the procedure and acceptance criteria upon which a judgment of acceptable radiopacity can be based and labeling claims substantiated.
General Information
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: F647 − 94(Reapproved 2006)
Standard Practice for
Evaluating and Specifying Implantable Shunt Assemblies for
Neurosurgical Application
ThisstandardisissuedunderthefixeddesignationF647;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.
INTRODUCTION
A hydrocephalus shunt assembly is a one-way pressure-activated or flow-controlling device or
combination of devices intended to be surgically implanted in the body of a patient with
hydrocephalusanddesignedtodivertcerebrospinalfluid(CSF)fromfluidcompartmentsinthecentral
nervous system (CNS) (the cerebral ventricles or other site within the cerebrospinal fluid system) to
an internal delivery site (internal shunt) in another part of the body or an external collection site
(external shunt), for the purpose of relieving elevated intracranial pressure or CSF volume.
A hydrocephalus shunt system typically consists of three basic elements: (1) an inflow (proximal)
catheter,whichdrainsCSFfromtheventricularsystem,lumbarsubarachnoidspaceorextraventricular
structureandtransmitsitto(2)anarrangementofoneormorevalveswhichregulate(s)thedifferential
pressure or controls flow through the system, and (3) an outflow (distal) catheter which drains CSF
into the cardiovascular system via the peritoneal cavity, heart or other suitable drainage site. In
addition, specialized accessory devices such as reservoirs, antisiphon devices and on-off valves and
filters are added at the discretion of the physician to modify performance or adapt the basic system to
the specialized needs of the patient.
Because of the considerable length of time over which a shunt or component may be required to
function after implantation, it is felt that it should be type-tested to ensure its durability. It has not yet
been found feasible to specify a test method of durability testing, but a test method is proposed in
Appendix X1.
1. Scope 1.3 Limitations—Although this practice includes a standard
test method for the evaluation of pressure/flow characteristics
1.1 This practice covers requirements for the evaluation and
of shunts or shunt components, it does not include specific
specification of implantable shunts as related to resistance to
pressure/flow requirements.
flow, direction of flow, materials, radiopacity, mechanical
properties, finish, sterility, and labeling of shunt assemblies. 1.4 The following components, that individually or in com-
bination comprise shunt assemblies, are considered to be
1.2 Devices to which this practice is applicable include, but
within the scope of this practice: catheters (such as atrial,
arenotlimitedto,thosethataretemporarilyimplantedtoeffect
peritoneal, ventricular), connectors, implantable accessory de-
external drainage; or permanently implanted to effect shunting
vices (such as antisiphon devices and reservoirs), valved
of fluid from a cerebral ventricle, a cyst, the subarachnoid
catheters and valves.
space to the peritoneal cavity, the venous circulation, or some
1.5 This standard does not purport to address all of the
other suitable internal delivery site, and intracranial bypass.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
1 priate safety and health practices and determine the applica-
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
bility of regulatory limitations prior to use.
F04.31 on Neurosurgical Standards.
NOTE 1—The following standards contain provisions that, through
Current edition approved Sept. 1, 2006. Published September 2006. Originally
approved in 1979. Last previous edition approved in 2000 as F647 – 94 (2000). reference in this text, constitute provisions of this practice.At the time of
DOI: 10.1520/F0647-94R06. publication, the editions indicated are valid. All standards are subject to
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F647 − 94 (2006)
revision, and parties to agreements based on this practice are encouraged
3.1.2 batch—a quantity of material that consists of a homo-
to investigate the possibility of applying the most recent editions of the
geneous mixture of common ingredients or a quantity of
standards indicated below. Devices or components, or both, whose
devices processed and controlled as an integral production run.
structures are comparable to that outlined in these standards are accept-
able.
3.1.3 calibration—the act of fixing, checking, or correcting
on a schedule, the accuracy and precision of a measuring
2. Referenced Documents
instrument and maintaining records of these activities.
2.1 ASTM Standards:
3.1.4 chambered valve—an element of a hydrocephalus
F55 Specification for Stainless Steel Bar and Wire for
shunt containing one or more valve mechanisms that is to
Surgical Implants (Withdrawn 1989)
facilitate selective flushing in the proximal or distal direction.
F56 Specification for Stainless Steel Sheet and Strip for
3.1.5 connector—a device intended for the joining and
Surgical Implants (Withdrawn 1989)
fixation of implantable shunt components at operation.
F67 Specification for Unalloyed Titanium, for Surgical Im-
plant Applications (UNS R50250, UNS R50400, UNS
3.1.6 distal (outflow) catheter—that part of a hydrocephalus
R50550, UNS R50700)
shuntassemblythatprovidesapassiveoutflowpathwayforthe
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
diversion of fluid from a compartment of the central nervous
Alloy Castings and Casting Alloy for Surgical Implants
system to the peritoneal cavity, venous circulation, or other
(UNS R30075)
internal delivery site. The outflow catheter may or may not
F90 Specification for Wrought Cobalt-20Chromium-
contain a pressure/flow regulating device.
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
3.1.7 flow-impedance device—those components of a shunt
tions (UNS R30605)
assembly which, by virtue of their resistance properties,
F138 Specification for Wrought 18Chromium-14Nickel-
provide the principal means of controlling intracranial pressure
2.5Molybdenum Stainless Steel Bar andWire for Surgical
or flow of cerebrospinal fluid, or both. Flow-impedance de-
Implants (UNS S31673)
vices include valved catheters and valves and the relevant
F469 Practice for Assessment of Compatibility of Nonpo-
constituent parts thereof.
rous Polymeric Materials for Surgical Implants with
Regard to Effect of Materials on Tissue (Withdrawn
3.1.8 fluid compartment—the portion of the central nervous
1986) system (CNS) including the ventricles and subdural space, and
F604 Specification for Silicone Elastomers Used in Medical
extraventricular structures such as cysts and hygromas.
Applications (Withdrawn 2001)
3.1.9 functional range—the representative pressure/flow
F640 Test Methods for Determining Radiopacity for Medi-
characteristics of a shunt or shunt element usually expressed in
cal Use
graphical form.
F897 Test Method for Measuring Fretting Corrosion of
3.1.10 hydrocephalus—the state of excessive accumulation
Osteosynthesis Plates and Screws
of cerebrospinal fluid (CSF) within the ventricular system of
NOTE2—AsuggestedmethodofdurabilitytestingisgiveninAppendix
the head due to a disturbance of secretion, flow or absorption,
X2.
usually resulting in a pathological increase in intracranial
pressure (ICP).
3. Terminology
3.1.11 hydrocephalus shunt—a one-way pressure-activated
3.1 Definitions of Terms Specific to This Standard:
or flow-controlling device or combination of devices intended
3.1.1 antisiphon device—a device implanted to counteract
to be surgically implanted in the body of a patient with
the affects of the hydrostatic column of the outflow catheter.
hydrocephalus and designed to divert cerebrospinal fluid from
Thisistominimizethegravity(alsotermed“siphoning”)effect
a fluid compartment in the central nervous system or CNS (the
of a hydrostatic pressure that may be created by the elevation
cerebral ventricles or other site within the cerebrospinal fluid
of the proximal (inflow) catheter in relation to the distal
system) to an internal delivery site in another part of the body
(outflow) catheter thus preventing the excessive drainage of
(internal shunt) or an external collection site (external shunt),
CSF caused by gravity.
forthepurposeofrelievingelevatedintracranialpressure(ICP)
3.1.1.1 Discussion—The Committee adopted the terms si-
or CSF volume.
phon effect and antisiphon device for this practice because they
3.1.12 hydrocephalus shunt assembly—a complete hydro-
are used in the medical literature. However, such devices are
cephalus shunt comprising all the components necessary for
designed to counteract the effects of gravity on the fluid in the
clinical use.
distal catheter when the patient is standing.
3.1.13 implantable accessory device—component intended
to facilitate the treatment of hydrocephalus by: providing
access to the shunt (such as reservoirs, antechambers, flushing
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
devices) or; modifying the performance characteristics of the
Standards volume information, refer to the standard’s Document Summary page on
shunt (such as on/off and antisiphon devices) or; reducing
the ASTM website.
hazards attendant to the presence of the shunt assembly (such
The last approved version of this historical standard is referenced on
www.astm.org. as in-line filters).
F647 − 94 (2006)
3.1.14 implantable external drainage catheter—that ele- 3.1.23.6 unit container—a package containing a single item
ment of an external drainage device which provides access to oracombinationofprocedure-relatedcomponentsorproducts.
a fluid compartment of the central nervous system.
3.1.23.7 unit pack—a pack containing a single unit or kit.
3.1.15 kit—a number of components in a common package
3.1.24 preassembled connection—a portion of the shunt
to be used for a single purpose on the same occasion.
assembly the components of which are preassembled at the
3.1.16 magnetizable—a metal that has the capacity to ac- time of manufacture and are intended to be permanently fixed
quire magnetic properties of sufficient force to become dan-
and not modified during a surgical procedure (for example, the
gerous due to movement or thermal effects, or both, or to site where the valve is chemically bonded or mechanically
degrade the MRI image to the point of making it diagnostically
joined to tubing).
or therapeutically useless.Ashunt system that is magnetizable
3.1.25 preimplantation test—a test that is performed on the
is not MRI-compatible.
shunt assembly in the operating room prior to implantation.
3.1.17 modifiable connection—aportionoftheshuntassem-
3.1.26 pressure/flow graph—a graphic representation of the
bly in which components are intended to be modified by the
composite performance characteristics of a population of flow
surgeonduringasurgicalprocedure(forexample,thelengthof
impedance devices.
a tube can be adjusted to accommodate the height of the
3.1.27 production line bench flow test—a test method used
patient).
by the manufacturer to verify that the pressure/flow character-
3.1.18 multipiece hydrocephalus shunt assembly—a com-
istics of each individual flow impedance device conforms to its
plete sterile, single-use hydrocephalus shunt, supplied either
functional range.
assembled by the manufacturer or in kit form for assembly by
3.1.28 proximal (inflow) catheter—that part of a hydro-
the physician typically consisting of an inflow catheter,
cephalus shunt assembly that is inserted into the cerebral
pressure-activatedorflow-controllingdeviceorcombinationof
ventricles or any other site in the craniospinal axis to provide
devices and an outflow catheter with requisite connectors
access to a fluid compartment of the central nervous system
required for assembly.
(for example, into a lateral ventricle) and therefore constitutes
3.1.19 nominal category—thegenericperformancecategory
the inflow pathway for the diversion of fluid through a shunt
of the pressure/flow characteristics of the shunt assembly
system.
typicallydefinedas“low,”“medium,”“high,”etc.,thelimitsof
3.1.29 radiopacity—the X-ray absorption properties that
which are defined by the manufacturer.
allow a shunt component to have clear and permanent visual-
3.1.20 nonmodifiable connection—see preassembled con-
ization fluoroscopically or on X-ray film after implantation.
nection.
(See Annex A1).
3.1.21 one-piece hydrocephalus shunt assembly—complete
3.1.30 referee test method—the methods in the published
sterile, single-use hydrocephalus shunt consisting of an inflow
standard for the device. The method and the corresponding
catheter integral with a pressure-activated or flow-controlling
requirements will be invoked when the performance of the
device or combination of devices and an integral outflow
medical device will be questioned. The manufacturer need not
catheter.
use this referee test method in the usual inspection and quality
3.1.22 on-off device—an accessory component specifically
control.
designed to permit alternate opening and closing of the shunt
3.1.31 reflux—a flow of fluid within a hydrocephalus shunt
system upon external activation.
towards the cerebral ventricles or cerebrospinal fluid system.
3.1.23 packaging—the protective wrapping of shunt sys-
3.1.32 shunt, v—to drain CSF from the CNS.
tems or components:
3.1.33 shunt assembly—any device or combination of de-
3.1.23.1 inner container—the packaging that is in direct
vices that functions to divert CSF from a fluid compartment of
contact with the implant.
the central nervous system to an internal delivery site (internal
3.1.23.2 multiple pack—a pack containing a number of unit
shunt) or an external collection site (external shunt).
packs.
3.1.34 shunt element—any component of a hydrocephalus
3.1.23.3 outer container or shelf container—a package,
shunt.
carton, or other container that may contain one or more unit
3.1.35 shunt filter—a device intended to remove particulate
containers. The packaging that envelopes the inner container
matter from the CSF before it passes through the shunt.
such that sterility and the integrity of that container is main-
tained. 3.1.36 sterile—in microbiology, free from all living organ-
isms; in practice, the condition of a product that has been
3.1.23.4 sterile pack—a pack intended to maintain the
subjected to a validated sterilization pro
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