1、Designation: F647 94 (Reapproved 2014)Standard Practice forEvaluating and Specifying Implantable Shunt Assemblies forNeurosurgical Application1This standard is issued under the fixed designation F647; the number immediately following the designation indicates the year of originaladoption or, in the
2、case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONA hydrocephalus shunt assembly is a one-way pressure-activated or flow-controlling devic
3、e orcombination of devices intended to be surgically implanted in the body of a patient withhydrocephalus and designed to divert cerebrospinal fluid (CSF) from fluid compartments in the centralnervous system (CNS) (the cerebral ventricles or other site within the cerebrospinal fluid system) toan int
4、ernal 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
5、drains CSF from the ventricular system, lumbar subarachnoid space or extraventricularstructure and transmits it to (2) an arrangement of one or more valves which regulate(s) the differentialpressure or controls flow through the system, and (3) an outflow (distal) catheter which drains CSFinto the ca
6、rdiovascular system via the peritoneal cavity, heart or other suitable drainage site. Inaddition, specialized accessory devices such as reservoirs, antisiphon devices and on-off valves andfilters are added at the discretion of the physician to modify performance or adapt the basic system tothe speci
7、alized needs of the patient.Because of the considerable length of time over which a shunt or component may be required tofunction after implantation, it is felt that it should be type-tested to ensure its durability. It has not yetbeen found feasible to specify a test method of durability testing, b
8、ut a test method is proposed inAppendix X1.1. Scope1.1 This practice covers requirements for the evaluation andspecification of implantable shunts as related to resistance toflow, direction of flow, materials, radiopacity, mechanicalproperties, finish, sterility, and labeling of shunt assemblies.1.2
9、 Devices to which this practice is applicable include, butare not limited to, those that are temporarily implanted to effectexternal drainage; or permanently implanted to effect shuntingof fluid from a cerebral ventricle, a cyst, the subarachnoidspace to the peritoneal cavity, the venous circulation
10、, or someother suitable internal delivery site, and intracranial bypass.1.3 LimitationsAlthough this practice includes a standardtest method for the evaluation of pressure/flow characteristicsof shunts or shunt components, it does not include specificpressure/flow requirements.1.4 The following comp
11、onents, that individually or in com-bination comprise shunt assemblies, are considered to bewithin the scope of this practice: catheters (such as atrial,peritoneal, ventricular), connectors, implantable accessory de-vices (such as antisiphon devices and reservoirs), valvedcatheters and valves.1.5 Th
12、is standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.NOTE 1The following s
13、tandards contain provisions that, throughreference in this text, constitute provisions of this practice. At the time ofpublication, the editions indicated are valid. All standards are subject torevision, and parties to agreements based on this practice are encouragedto investigate the possibility of
14、 applying the most recent editions of thestandards indicated below. Devices or components, or both, whose1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.31 on Neurosurgical Standards.Curren
15、t edition approved Nov. 15, 2014. Published November 2014. Originallyapproved in 1979. Last previous edition approved in 2006 as F647 94 (2006).DOI: 10.1520/F0647-94R14.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1structures are co
16、mparable to that outlined in these standards are accept-able.2. Referenced Documents2.1 ASTM Standards:2F55 Specification for Stainless Steel Bar and Wire forSurgical Implants (Withdrawn 1989)3F56 Specification for Stainless Steel Sheet and Strip forSurgical Implants (Withdrawn 1989)3F67 Specificati
17、on for Unalloyed Titanium, for Surgical Im-plant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Allo
18、y for Surgical Implant Applica-tions (UNS R30605)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F469 Practice for Assessment of Compatibility of Nonpo-rous Polymeric Materials for Surgical Implants withRegard to Effect o
19、f Materials on Tissue (Withdrawn1986)3F604 Specification for Silicone Elastomers Used in MedicalApplications (Withdrawn 2001)3F640 Test Methods for Determining Radiopacity for Medi-cal UseF897 Test Method for Measuring Fretting Corrosion ofOsteosynthesis Plates and ScrewsNOTE 2Asuggested method of d
20、urability testing is given in AppendixX2.3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 antisiphon devicea device implanted to counteractthe affects of the hydrostatic column of the outflow catheter.This is to minimize the gravity (also termed “siphoning”) effectof a hydrosta
21、tic pressure that may be created by the elevationof the proximal (inflow) catheter in relation to the distal(outflow) catheter thus preventing the excessive drainage ofCSF caused by gravity.3.1.1.1 DiscussionThe Committee adopted the terms si-phon effect and antisiphon device for this practice becau
22、se theyare used in the medical literature. However, such devices aredesigned to counteract the effects of gravity on the fluid in thedistal catheter when the patient is standing.3.1.2 batcha quantity of material that consists of a homo-geneous mixture of common ingredients or a quantity ofdevices pr
23、ocessed and controlled as an integral production run.3.1.3 calibrationthe act of fixing, checking, or correctingon a schedule, the accuracy and precision of a measuringinstrument and maintaining records of these activities.3.1.4 chambered valvean element of a hydrocephalusshunt containing one or mor
24、e valve mechanisms that is tofacilitate selective flushing in the proximal or distal direction.3.1.5 connectora device intended for the joining andfixation of implantable shunt components at operation.3.1.6 distal (outflow) catheterthat part of a hydrocephalusshunt assembly that provides a passive o
25、utflow pathway for thediversion of fluid from a compartment of the central nervoussystem to the peritoneal cavity, venous circulation, or otherinternal delivery site. The outflow catheter may or may notcontain a pressure/flow regulating device.3.1.7 flow-impedance devicethose components of a shuntas
26、sembly which, by virtue of their resistance properties,provide the principal means of controlling intracranial pressureor flow of cerebrospinal fluid, or both. Flow-impedance de-vices include valved catheters and valves and the relevantconstituent parts thereof.3.1.8 fluid compartmentthe portion of
27、the central nervoussystem (CNS) including the ventricles and subdural space, andextraventricular structures such as cysts and hygromas.3.1.9 functional rangethe representative pressure/flowcharacteristics of a shunt or shunt element usually expressed ingraphical form.3.1.10 hydrocephalusthe state of
28、 excessive accumulationof cerebrospinal fluid (CSF) within the ventricular system ofthe head due to a disturbance of secretion, flow or absorption,usually resulting in a pathological increase in intracranialpressure (ICP).3.1.11 hydrocephalus shunta one-way pressure-activatedor flow-controlling devi
29、ce or combination of devices intendedto be surgically implanted in the body of a patient withhydrocephalus and designed to divert cerebrospinal fluid froma fluid compartment in the central nervous system or CNS (thecerebral ventricles or other site within the cerebrospinal fluidsystem) to an interna
30、l 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 assemblya complete hydro-cephalus shunt comprising all the components necessary forcli
31、nical use.3.1.13 implantable accessory devicecomponent intendedto facilitate the treatment of hydrocephalus by: providingaccess to the shunt (such as reservoirs, antechambers, flushingdevices) or; modifying the performance characteristics of theshunt (such as on/off and antisiphon devices) or; reduc
32、inghazards attendant to the presence of the shunt assembly (suchas in-line filters).3.1.14 implantable external drainage catheterthat ele-ment of an external drainage device which provides access toa fluid compartment of the central nervous system.3.1.15 kita number of components in a common package
33、to be used for a single purpose on the same occasion.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The las
34、t approved version of this historical standard is referenced onwww.astm.org.F647 94 (2014)23.1.16 magnetizablea metal that has the capacity to ac-quire magnetic properties of sufficient force to become dan-gerous due to movement or thermal effects, or both, or todegrade the MRI image to the point of
35、 making it diagnosticallyor therapeutically useless. A shunt system that is magnetizableis not MRI-compatible.3.1.17 modifiable connectiona portion of the shunt assem-bly in which components are intended to be modified by thesurgeon during a surgical procedure (for example, the length ofa tube can b
36、e adjusted to accommodate the height of thepatient).3.1.18 multipiece hydrocephalus shunt assemblya com-plete sterile, single-use hydrocephalus shunt, supplied eitherassembled by the manufacturer or in kit form for assembly bythe physician typically consisting of an inflow catheter,pressure-activate
37、d or flow-controlling device or combination ofdevices and an outflow catheter with requisite connectorsrequired for assembly.3.1.19 nominal categorythe generic performance categoryof the pressure/flow characteristics of the shunt assemblytypically defined as “low,”“ medium,” “high,” etc., the limits
38、 ofwhich are defined by the manufacturer.3.1.20 nonmodifiable connectionsee preassembled con-nection.3.1.21 one-piece hydrocephalus shunt assemblycompletesterile, single-use hydrocephalus shunt consisting of an inflowcatheter integral with a pressure-activated or flow-controllingdevice or combinatio
39、n of devices and an integral outflowcatheter.3.1.22 on-off devicean accessory component specificallydesigned to permit alternate opening and closing of the shuntsystem upon external activation.3.1.23 packagingthe protective wrapping of shunt sys-tems or components:3.1.23.1 inner containerthe packagi
40、ng that is in directcontact with the implant.3.1.23.2 multiple packa pack containing a number of unitpacks.3.1.23.3 outer container or shelf containera package,carton, or other container that may contain one or more unitcontainers. The packaging that envelopes the inner containersuch that sterility
41、and the integrity of that container is main-tained.3.1.23.4 sterile packa pack intended to maintain thesterility of the contents and comprising an inner and outercontainer.3.1.23.5 transit containera package, carton, or other con-tainer that may contain one or more unit containers used toprotect the
42、 contents during shipping of the product from themanufacturer to the end user.3.1.23.6 unit containera package containing a single itemor a combination of procedure-related components or products.3.1.23.7 unit packa pack containing a single unit or kit.3.1.24 preassembled connectiona portion of the
43、shuntassembly the components of which are preassembled at thetime of manufacture and are intended to be permanently fixedand not modified during a surgical procedure (for example, thesite where the valve is chemically bonded or mechanicallyjoined to tubing).3.1.25 preimplantation testa test that is
44、performed on theshunt assembly in the operating room prior to implantation.3.1.26 pressure/flow grapha graphic representation of thecomposite performance characteristics of a population of flowimpedance devices.3.1.27 production line bench flow testa test method usedby the manufacturer to verify tha
45、t the pressure/flow character-istics of each individual flow impedance device conforms to itsfunctional range.3.1.28 proximal (inflow) catheterthat part of a hydro-cephalus shunt assembly that is inserted into the cerebralventricles or any other site in the craniospinal axis to provideaccess to a fl
46、uid compartment of the central nervous system(for example, into a lateral ventricle) and therefore constitutesthe inflow pathway for the diversion of fluid through a shuntsystem.3.1.29 radiopacitythe X-ray absorption properties thatallow a shunt component to have clear and permanent visual-ization f
47、luoroscopically or on X-ray film after implantation.(See Annex A1).3.1.30 referee test methodthe methods in the publishedstandard for the device. The method and the correspondingrequirements will be invoked when the performance of themedical device will be questioned. The manufacturer need notuse th
48、is referee test method in the usual inspection and qualitycontrol.3.1.31 refluxa flow of fluid within a hydrocephalus shunttowards the cerebral ventricles or cerebrospinal fluid system.3.1.32 shunt, vto drain CSF from the CNS.3.1.33 shunt assemblyany device or combination of de-vices that functions
49、to divert CSF from a fluid compartment ofthe central nervous system to an internal delivery site (internalshunt) or an external collection site (external shunt).3.1.34 shunt elementany component of a hydrocephalusshunt.3.1.35 shunt filtera device intended to remove particulatematter from the CSF before it passes through the shunt.3.1.36 sterilein microbiology, free from all living organ-isms; in practice, the condition of a product that has beensubjected to a validated sterilization process and maintained inthis state by suitable protec
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