ASTM F647-94(2014)
(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
4.1 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.
1.5 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.
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Designation: F647 − 94 (Reapproved 2014)
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 of shunts or shunt components, it does not include specific
pressure/flow requirements.
1.1 This practice covers requirements for the evaluation and
specification of implantable shunts as related to resistance to
1.4 The following components, that individually or in com-
flow, direction of flow, materials, radiopacity, mechanical
bination comprise shunt assemblies, are considered to be
properties, finish, sterility, and labeling of shunt assemblies.
within the scope of this practice: catheters (such as atrial,
1.2 Devices to which this practice is applicable include, but peritoneal, ventricular), connectors, implantable accessory de-
arenotlimitedto,thosethataretemporarilyimplantedtoeffect vices (such as antisiphon devices and reservoirs), valved
external drainage; or permanently implanted to effect shunting
catheters and valves.
of fluid from a cerebral ventricle, a cyst, the subarachnoid
1.5 This standard does not purport to address all of the
space to the peritoneal cavity, the venous circulation, or some
safety concerns, if any, associated with its use. It is the
other suitable internal delivery site, and intracranial bypass.
responsibility of the user of this standard to establish appro-
1.3 Limitations—Although this practice includes a standard
priate safety and health practices and determine the applica-
test method for the evaluation of pressure/flow characteristics
bility of regulatory limitations prior to use.
NOTE 1—The following standards contain provisions that, through
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
reference in this text, constitute provisions of this practice.At the time of
Surgical Materials and Devices and is the direct responsibility of Subcommittee
publication, the editions indicated are valid. All standards are subject to
F04.31 on Neurosurgical Standards.
revision, and parties to agreements based on this practice are encouraged
Current edition approved Nov. 15, 2014. Published November 2014. Originally
to investigate the possibility of applying the most recent editions of the
approved in 1979. Last previous edition approved in 2006 as F647 – 94 (2006).
DOI: 10.1520/F0647-94R14. standards indicated below. Devices or components, or both, whose
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F647 − 94 (2014)
structures are comparable to that outlined in these standards are accept-
3.1.3 calibration—the act of fixing, checking, or correcting
able.
on a schedule, the accuracy and precision of a measuring
instrument and maintaining records of these activities.
2. Referenced Documents
3.1.4 chambered valve—an element of a hydrocephalus
2.1 ASTM Standards:
shunt containing one or more valve mechanisms that is to
F55 Specification for Stainless Steel Bar and Wire for
facilitate selective flushing in the proximal or distal direction.
Surgical Implants (Withdrawn 1989)
3.1.5 connector—a device intended for the joining and
F56 Specification for Stainless Steel Sheet and Strip for
fixation of implantable shunt components at operation.
Surgical Implants (Withdrawn 1989)
3.1.6 distal (outflow) catheter—that part of a hydrocephalus
F67 Specification for Unalloyed Titanium, for Surgical Im-
shuntassemblythatprovidesapassiveoutflowpathwayforthe
plant Applications (UNS R50250, UNS R50400, UNS
diversion of fluid from a compartment of the central nervous
R50550, UNS R50700)
system to the peritoneal cavity, venous circulation, or other
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
internal delivery site. The outflow catheter may or may not
Alloy Castings and Casting Alloy for Surgical Implants
contain a pressure/flow regulating device.
(UNS R30075)
F90 Specification for Wrought Cobalt-20Chromium- 3.1.7 flow-impedance device—those components of a shunt
15Tungsten-10NickelAlloy for Surgical ImplantApplica- assembly which, by virtue of their resistance properties,
tions (UNS R30605) provide the principal means of controlling intracranial pressure
F138 Specification for Wrought 18Chromium-14Nickel- or flow of cerebrospinal fluid, or both. Flow-impedance de-
2.5Molybdenum Stainless Steel Bar andWire for Surgical vices include valved catheters and valves and the relevant
Implants (UNS S31673) constituent parts thereof.
F469 Practice for Assessment of Compatibility of Nonpo-
3.1.8 fluid compartment—the portion of the central nervous
rous Polymeric Materials for Surgical Implants with
system (CNS) including the ventricles and subdural space, and
Regard to Effect of Materials on Tissue (Withdrawn
extraventricular structures such as cysts and hygromas.
1986)
3.1.9 functional range—the representative pressure/flow
F604 Specification for Silicone Elastomers Used in Medical
characteristics of a shunt or shunt element usually expressed in
Applications (Withdrawn 2001)
graphical form.
F640 Test Methods for Determining Radiopacity for Medi-
3.1.10 hydrocephalus—the state of excessive accumulation
cal Use
of cerebrospinal fluid (CSF) within the ventricular system of
F897 Test Method for Measuring Fretting Corrosion of
the head due to a disturbance of secretion, flow or absorption,
Osteosynthesis Plates and Screws
usually resulting in a pathological increase in intracranial
NOTE2—AsuggestedmethodofdurabilitytestingisgiveninAppendix
pressure (ICP).
X2.
3.1.11 hydrocephalus shunt—a one-way pressure-activated
or flow-controlling device or combination of devices intended
3. Terminology
to be surgically implanted in the body of a patient with
3.1 Definitions of Terms Specific to This Standard:
hydrocephalus and designed to divert cerebrospinal fluid from
3.1.1 antisiphon device—a device implanted to counteract
a fluid compartment in the central nervous system or CNS (the
the affects of the hydrostatic column of the outflow catheter.
cerebral ventricles or other site within the cerebrospinal fluid
Thisistominimizethegravity(alsotermed“siphoning”)effect
system) to an internal delivery site in another part of the body
of a hydrostatic pressure that may be created by the elevation
(internal shunt) or an external collection site (external shunt),
of the proximal (inflow) catheter in relation to the distal
forthepurposeofrelievingelevatedintracranialpressure(ICP)
(outflow) catheter thus preventing the excessive drainage of
or CSF volume.
CSF caused by gravity.
3.1.12 hydrocephalus shunt assembly—a complete hydro-
3.1.1.1 Discussion—The Committee adopted the terms si-
cephalus shunt comprising all the components necessary for
phon effect and antisiphon device for this practice because they
clinical use.
are used in the medical literature. However, such devices are
3.1.13 implantable accessory device—component intended
designed to counteract the effects of gravity on the fluid in the
to facilitate the treatment of hydrocephalus by: providing
distal catheter when the patient is standing.
access to the shunt (such as reservoirs, antechambers, flushing
3.1.2 batch—a quantity of material that consists of a homo-
devices) or; modifying the performance characteristics of the
geneous mixture of common ingredients or a quantity of
shunt (such as on/off and antisiphon devices) or; reducing
devices processed and controlled as an integral production run.
hazards attendant to the presence of the shunt assembly (such
as in-line filters).
2 3.1.14 implantable external drainage catheter—that ele-
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
ment of an external drainage device which provides access to
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
a fluid compartment of the central nervous system.
the ASTM website.
3.1.15 kit—a number of components in a common package
The last approved version of this historical standard is referenced on
www.astm.org. to be used for a single purpose on the same occasion.
F647 − 94 (2014)
3.1.16 magnetizable—a metal that has the capacity to ac- 3.1.24 preassembled connection—a portion of the shunt
quire magnetic properties of sufficient force to become dan- assembly the components of which are preassembled at the
gerous due to movement or thermal effects, or both, or to time of manufacture and are intended to be permanently fixed
degrade the MRI image to the point of making it diagnostically and not modified during a surgical procedure (for example, the
or therapeutically useless.Ashunt system that is magnetizable site where the valve is chemically bonded or mechanically
is not MRI-compatible. joined to tubing).
3.1.17 modifiable connection—aportionoftheshuntassem- 3.1.25 preimplantation test—a test that is performed on the
bly in which components are intended to be modified by the shunt assembly in the operating room prior to implantation.
surgeonduringasurgicalprocedure(forexample,thelengthof
3.1.26 pressure/flow graph—a graphic representation of the
a tube can be adjusted to accommodate the height of the
composite performance characteristics of a population of flow
patient).
impedance devices.
3.1.18 multipiece hydrocephalus shunt assembly—a com-
3.1.27 production line bench flow test—a test method used
plete sterile, single-use hydrocephalus shunt, supplied either
by the manufacturer to verify that the pressure/flow character-
assembled by the manufacturer or in kit form for assembly by
istics of each individual flow impedance device conforms to its
the physician typically consisting of an inflow catheter,
functional range.
pressure-activatedorflow-controllingdeviceorcombinationof
3.1.28 proximal (inflow) catheter—that part of a hydro-
devices and an outflow catheter with requisite connectors
cephalus shunt assembly that is inserted into the cerebral
required for assembly.
ventricles or any other site in the craniospinal axis to provide
3.1.19 nominal category—thegenericperformancecategory
access to a fluid compartment of the central nervous system
of the pressure/flow characteristics of the shunt assembly
(for example, into a lateral ventricle) and therefore constitutes
typicallydefinedas“low,”“medium,”“high,”etc.,thelimitsof
the inflow pathway for the diversion of fluid through a shunt
which are defined by the manufacturer.
system.
3.1.20 nonmodifiable connection—see preassembled con-
3.1.29 radiopacity—the X-ray absorption properties that
nection.
allow a shunt component to have clear and permanent visual-
ization fluoroscopically or on X-ray film after implantation.
3.1.21 one-piece hydrocephalus shunt assembly—complete
(See Annex A1).
sterile, single-use hydrocephalus shunt consisting of an inflow
catheter integral with a pressure-activated or flow-controlling
3.1.30 referee test method—the methods in the published
device or combination of devices and an integral outflow
standard for the device. The method and the corresponding
catheter.
requirements will be invoked when the performance of the
medical device will be questioned. The manufacturer need not
3.1.22 on-off device—an accessory component specifically
use this referee test method in the usual inspection and quality
designed to permit alternate opening and closing of the shunt
control.
system upon external activation.
3.1.31 reflux—a flow of fluid within a hydrocephalus shunt
3.1.23 packaging—the protective wrapping of shunt sys-
towards the cerebral ventricles or cerebrospinal fluid system.
tems or components:
3.1.32 shunt, v—to drain CSF from the CNS.
3.1.23.1 inner container—the packaging that is in direct
contact with the implant.
3.1.33 shunt assembly—any device or combination of de-
vices that functions to divert CSF from a fluid compartment of
3.1.23.2 multiple pack—a pack containing a number of unit
the central nervous system to an internal delivery site (internal
packs.
shunt) or an external collection site (external shunt).
3.1.23.3 outer container or shelf container—a package,
3.1.34 shunt element—any component of a hydrocephalus
carton, or other container that may contain one or more unit
shunt.
containers. The packaging that envelopes the inner container
such that sterility and the integrity of that container is main-
3.1.35 shunt filter—a device intended to remove particulate
tained.
matter from the CSF before it passes through the shunt.
3.1.23.4 sterile pack—a pack intended to maintain the
3.1.36 sterile—in microbiology, free from all living organ-
sterility of the contents and comprising an inner and outer
isms; in practice, the condition of a product that has been
container.
subjected to a validated sterilization process and maintained in
this state by suitable protection.
3.1.23.5 transit container—a package, carton
...
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: F647 − 94 (Reapproved 2006) F647 − 94 (Reapproved 2014)
Standard Practice for
Evaluating and Specifying Implantable Shunt Assemblies for
Neurosurgical Application
This standard is issued under the fixed designation F647; 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.
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
hydrocephalus and designed to divert cerebrospinal fluid (CSF) from fluid compartments in the central
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, which drains CSF from the ventricular system, lumbar subarachnoid space or extraventricular
structure and transmits it to (2) an arrangement of one or more valves which regulate(s) the differential
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
1.1 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.
1.5 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
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 Sept. 1, 2006Nov. 15, 2014. Published September 2006November 2014. Originally approved in 1979. Last previous edition approved in
20002006 as F647 – 94 (2000).(2006). DOI: 10.1520/F0647-94R06.10.1520/F0647-94R14.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F647 − 94 (2014)
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.
2. Referenced Documents
2.1 ASTM Standards:
F55 Specification for Stainless Steel Bar and Wire for Surgical Implants (Withdrawn 1989)
F56 Specification for Stainless Steel Sheet and Strip for Surgical Implants (Withdrawn 1989)
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F469 Practice for Assessment of Compatibility of Nonporous Polymeric Materials for Surgical Implants with Regard to Effect
of Materials on Tissue (Withdrawn 1986)
F604 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
F640 Test Methods for Determining Radiopacity for Medical Use
F897 Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
NOTE 2—A suggested method of durability testing is given in Appendix X2.
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 antisiphon device—a device implanted to counteract the affects of the hydrostatic column of the outflow catheter. This is
to minimize the gravity (also termed “siphoning”) effect of a hydrostatic pressure that may be created by the elevation of the
proximal (inflow) catheter in relation to the distal (outflow) catheter thus preventing the excessive drainage of CSF caused by
gravity.
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
The last approved version of this historical standard is referenced on www.astm.org.
3.1.1.1 Discussion—
The Committee adopted the terms siphon effect and antisiphon device for this practice because they are used in the medical
literature. However, such devices are designed to counteract the effects of gravity on the fluid in the distal catheter when the patient
is standing.
3.1.2 batch—a quantity of material that consists of a homogeneous mixture of common ingredients or a quantity of devices
processed and controlled as an integral production run.
3.1.3 calibration—the act of fixing, checking, or correcting on a schedule, the accuracy and precision of a measuring instrument
and maintaining records of these activities.
3.1.4 chambered valve—an element of a hydrocephalus shunt containing one or more valve mechanisms that is to facilitate
selective flushing in the proximal or distal direction.
3.1.5 connector—a device intended for the joining and fixation of implantable shunt components at operation.
3.1.6 distal (outflow) catheter—that part of a hydrocephalus shunt assembly that provides a passive outflow pathway for the
diversion of fluid from a compartment of the central nervous system to the peritoneal cavity, venous circulation, or other internal
delivery site. The outflow catheter may or may not contain a pressure/flow regulating device.
3.1.7 flow-impedance device—those components of a shunt assembly which, by virtue of their resistance properties, provide the
principal means of controlling intracranial pressure or flow of cerebrospinal fluid, or both. Flow-impedance devices include valved
catheters and valves and the relevant constituent parts thereof.
3.1.8 fluid compartment—the portion of the central nervous system (CNS) including the ventricles and subdural space, and
extraventricular structures such as cysts and hygromas.
3.1.9 functional range—the representative pressure/flow characteristics of a shunt or shunt element usually expressed in
graphical form.
F647 − 94 (2014)
3.1.10 hydrocephalus—the state of excessive accumulation of cerebrospinal fluid (CSF) within the ventricular system of the
head due to a disturbance of secretion, flow or absorption, usually resulting in a pathological increase in intracranial pressure (ICP).
3.1.11 hydrocephalus shunt—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 hydrocephalus and designed to divert cerebrospinal fluid from a fluid
compartment in the central nervous system or CNS (the cerebral ventricles or other site within the cerebrospinal fluid system) to
an internal delivery site in another part of the body (internal shunt) or an external collection site (external shunt), for the purpose
of relieving elevated intracranial pressure (ICP) or CSF volume.
3.1.12 hydrocephalus shunt assembly—a complete hydrocephalus shunt comprising all the components necessary for clinical
use.
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 devices) or; modifying the performance characteristics of the shunt (such as
on/off and antisiphon devices) or; reducing hazards attendant to the presence of the shunt assembly (such as in-line filters).
3.1.14 implantable external drainage catheter—that element of an external drainage device which provides access to a fluid
compartment of the central nervous system.
3.1.15 kit—a number of components in a common package to be used for a single purpose on the same occasion.
3.1.16 magnetizable—a metal that has the capacity to acquire magnetic properties of sufficient force to become dangerous due
to movement or thermal effects, or both, or to degrade the MRI image to the point of making it diagnostically or therapeutically
useless. A shunt system that is magnetizable is not MRI-compatible.
3.1.17 modifiable connection—a portion of the shunt assembly in which components are intended to be modified by the surgeon
during a surgical procedure (for example, the length of a tube can be adjusted to accommodate the height of the patient).
3.1.18 multipiece hydrocephalus shunt assembly—a complete sterile, single-use hydrocephalus shunt, supplied either assembled
by the manufacturer or in kit form for assembly by the physician typically consisting of an inflow catheter, pressure-activated or
flow-controlling device or combination of devices and an outflow catheter with requisite connectors required for assembly.
3.1.19 nominal category—the generic performance category of the pressure/flow characteristics of the shunt assembly typically
defined as “low,”“ medium,” “high,” etc., the limits of which are defined by the manufacturer.
3.1.20 nonmodifiable connection—see preassembled connection.
3.1.21 one-piece hydrocephalus shunt assembly—complete sterile, single-use hydrocephalus shunt consisting of an inflow
catheter integral with a pressure-activated or flow-controlling device or combination of devices and an integral outflow catheter.
3.1.22 on-off device—an accessory component specifically designed to permit alternate opening and closing of the shunt system
upon external activation.
3.1.23 packaging—the protective wrapping of shunt systems or components:
3.1.23.1 inner container—the packaging that is in direct contact with the implant.
3.1.23.2 multiple pack—a pack containing a number of unit packs.
3.1.23.3 outer container or shelf container—a package, carton, or other container that may contain one or more unit containers.
The packaging that envelopes the inner container such that sterility and the integrity of that container is maintained.
3.1.23.4 sterile pack—a pack intended to maintain the sterility of the contents and comprising an inner and outer container.
3.1.23.5 transit container—a package, carton, or other container that may contain one or more unit containers used to protect
the contents during shipping of the product from the manufacturer to the end user.
3.1.23.6 unit container—a package containing a single item or a combination of procedure-related components or products.
3.1.23.7 unit pack—a pack containing a single unit or kit.
3.1.24 preassembled connection—a portion of the shunt assembly the components of which are preassembled at the time of
manufacture and are intended to be permanently fixed and not modified during a surgical procedure (for example, the site where
the valve is chemically bonded or mechanically joined to tubing).
3.1.25 preimplantation test—a test that is performed on the shunt assembly in the operating room prior to implantation.
3.1.26 pressure/flow graph—a graphic representation of the composite performance characteristics of a population of flow
impedance devices.
3.1.27 production line bench flow test—a test method used by the manufacturer to verify that the pressure/flow characteristics
of each individual flow impedance device conforms to its functional range.
3.1.28 proximal (inflow) catheter—that part of a hydrocephalus shunt assembly that is inserted into the cerebral ventricles or
any other site in the craniospinal axis to provide access to a fluid compartment of the central nervous system (for example, into
a lateral ventricle) and therefore constitutes the inflow pathway for the diversion of fluid through a shunt system.
F647 − 94 (2014)
3.1.29 radiopacity—the X-ray absorption properties that allow a shunt component to have clear and permanent visualization
fluoroscopically or on X-ray film after implantation. (See Annex A1).
3.1.30 referee test method—the methods in the published standard for the device. The method and the corresponding
requirements will be invoked when the performance of the medical device will be questioned
...
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