ASTM F647-22

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.
Note 1: The standards in Section 2 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 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.  
1.6 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: 30-Sep-2022
• 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

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: F647 − 22
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, which drains CSF from the ventricular system, lumbar subarachnoid space, or extraventricu-
lar 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 1.4 The following components that individually or in com-
bination comprise shunt assemblies are considered to be within
1.1 This practice covers requirements for the evaluation and
the scope of this practice: catheters (such as atrial, peritoneal,
specification of implantable shunts as related to resistance to
ventricular), connectors, implantable accessory devices (such
flow, direction of flow, materials, radiopacity, mechanical
as antisiphon devices and reservoirs), valved catheters, and
properties, finish, sterility, and labeling of shunt assemblies.
valves.
1.2 Devices to which this practice is applicable include, but
NOTE 1—The standards in Section 2 contain provisions that, through
arenotlimitedto,thosethataretemporarilyimplantedtoeffect
reference in this text, constitute provisions of this practice.At the time of
external drainage; or permanently implanted to effect shunting
publication, the editions indicated are valid. All standards are subject to
of fluid from a cerebral ventricle, a cyst, the subarachnoid
revision, and parties to agreements based on this practice are encouraged
space to the peritoneal cavity, the venous circulation, or some
to investigate the possibility of applying the most recent editions of the
standards indicated below. Devices or components, or both, whose
other suitable internal delivery site, and intracranial bypass.
structures are comparable to that outlined in these standards are accept-
1.3 Limitations—Although this practice includes a standard
able.
test method for the evaluation of pressure/flow characteristics
1.5 This standard does not purport to address all of the
of shunts or shunt components, it does not include specific
safety concerns, if any, associated with its use. It is the
pressure/flow requirements.
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
mine the applicability of regulatory limitations prior to use.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.31 on Neurosurgical Standards.
1.6 This international standard was developed in accor-
Current edition approved Oct. 1, 2022. Published October 2022. Originally
dance with internationally recognized principles on standard-
approved in 1979. Last previous edition approved in 2014 as F647 – 94 (2014).
DOI: 10.1520/F0647-22. ization established in the Decision on Principles for the
Copyright © ASTM International, 100 Barr Harbor Drive, PO B
...

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 2014) F647 − 22
Standard Practice for
Evaluating and Specifying Implantable Shunt Assemblies for
1
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 extraventricu-
lar 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
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 Nov. 15, 2014Oct. 1, 2022. Published November 2014October 2022. Originally approved in 1979. Last previous edition approved in 20062014
as F647 – 94 (2006).(2014). DOI: 10.1520/F0647-94R14.10.1520/F0647-22.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F647 − 22
1.4 The following components,components that individually or in combination comprise shunt assemblies,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.
NOTE 1—The standards in Section 2 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 standard does not purport to address all of the safety concern
...