ASTM F647-94(2006)

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

• Status: Historical
• Publication Date: 31-Aug-2006
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.31 - Neurosurgical Standards

Relations

• Replaces: ASTM F647-94(2000) - Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
• Effective Date: 01-Sep-2006
• Referred By: ASTM F640-23 - Standard Test Methods for Determining Radiopacity for Medical Use
• Effective Date: 01-Sep-2006

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F647 − 94(Reapproved 2006)
Standard Practice for
Evaluating and Specifying Implantable Shunt Assemblies for
1
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
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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,
...