ASTM_F_647_-_94_2014.pdf

Designation:F64794(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 case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.INTRODUCTIONA hydrocephalus shunt assembly is a one-way pressure-activated or flow-controlling device 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 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 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 cardiovascular 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 specialized 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,but 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 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,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 components,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 This 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.NOTE1The following standards 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 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.Current 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 States1 structures are comparable 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 Specification 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 SpecificationforWroughtCobalt-20Chromium-15Tungsten-10Nickel Alloy