ASTM F647-1994(2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application《神经外科用可植入分路组件的评定和确定标准实施规程》.pdf

《ASTM F647-1994(2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application《神经外科用可植入分路组件的评定和确定标准实施规程》.pdf》由会员分享，可在线阅读，更多相关《ASTM F647-1994(2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application《神经外科用可植入分路组件的评定和确定标准实施规程》.pdf（12页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: F 647 94 (Reapproved 2006)Standard Practice forEvaluating and Specifying Implantable Shunt Assemblies forNeurosurgical Application1This standard is issued under the fixed designation F 647; the number immediately following the designation indicates the year oforiginal adoption or, in th

2、e case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.INTRODUCTIONA hydrocephalus shunt assembly is a one-way pressure-activated or flow-controlling de

3、vice 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

4、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, whi

5、ch 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

6、 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 sp

7、ecialized 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

8、, 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.

9、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 circulat

10、ion, 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 c

11、omponents, 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

12、 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.NOTE 1The followin

13、g standards contain provisions that, throughreference in this text, constitute provisions of this practice. At the time of1This practice is under the jurisdiction of ASTM Committee F04 on SurgicalMaterials and Devices and is the direct responsibility of Subcommittee F4.31 onNeurosurgical Standards.C

14、urrent edition approved Sept. 1, 2006. Published September 2006. Originallyapproved in 1979. Last previous edition approved in 2000 as F 647 94 (2000).1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.publication, the editions indicate

15、d 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, whosestructures are comparable to that outlined in th

16、ese standards are accept-able.2. Referenced Documents2.1 ASTM Standards:2F55 Specification for Stainless Steel Bar and Wire forSurgical Implants3F 56 Specification for Stainless Steel Sheet and Strip forSurgical Implants3F67 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS

17、 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 Alloy for Surgical Implant Applica-tions (UNS R30605)F 138 Specificati

18、on for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 469 Practice for Assessment of Compatibility of Nonpo-rous Polymeric Materials for Surgical Implants with Re-gard to Effect of Materials on Tissue3F 604 Specification for Silicone Elastom

19、ers Used in Medi-cal Applications3F 640 Test Methods for Radiopacity of Plastics for MedicalUseF 897 Test Method for Measuring Fretting Corrosion ofOsteosynthesis Plates and ScrewsNOTE 2Asuggested method of durability testing is given inAppendixX2.3. Terminology3.1 Definitions of Terms Specific to T

20、his 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 hydrostatic pressure that may be created by the elevationof the proximal (inflow) catheter in relatio

21、n 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 because theyare used in the medical literature. However, such devices aredesigned to counteract th

22、e 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 processed and controlled as an integral production run.3.1.3 calibrationthe act of fixing, chec

23、king, 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 more valve mechanisms that is tofacilitate selective flushing in the proximal or distal directio

24、n.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 outflow pathway for thediversion of fluid from a compartment of the central nervoussystem to t

25、he 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 shuntassembly which, by virtue of their resistance properties,provide the principal means of control

26、ling 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 the central nervoussystem (CNS) including the ventricles and subdural space, andextraventricu

27、lar 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 excessive accumulationof cerebrospinal fluid (CSF) within the ventricular system ofthe head

28、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 device or combination of devices intendedto be surgically implanted in the body of a patient with

29、hydrocephalus 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 internal delivery site in another part of the body(internal shunt) or an external collection site (e

30、xternal 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 forclinical use.3.1.13 implantable accessory devicecomponent intendedto facilitate the treatment of

31、 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; reducinghazards attendant to the presence of the shunt assembly (suchas in-line filters).3.1.14 im

32、plantable 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 packageto be used for a single purpose on the same occasion.2For referenced ASTM standards, visit th

33、e 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.3Withdrawn.F 647 94 (2006)23.1.16 magnetizablea metal that has the capacity to ac-quire magnetic prop

34、erties of sufficient force to become dan-gerous due to movement or thermal effects, or both, or todegrade the MRI image to the point of making it diagnosticallyor therapeutically useless. A shunt system that is magnetizableis not MRI-compatible.3.1.17 modifiable connectiona portion of the shunt as-s

35、embly in which components are intended to be modified bythe surgeon during a surgical procedure (for example, thelength of a tube can be adjusted to accommodate the height ofthe patient).3.1.18 multipiece hydrocephalus shunt assemblya com-plete sterile, single-use hydrocephalus shunt, supplied eithe

36、rassembled by the manufacturer or in kit form for assembly bythe physician typically consisting of an inflow catheter,pressure-activated or flow-controlling device or combination ofdevices and an outflow catheter with requisite connectorsrequired for assembly.3.1.19 nominal categorythe generic perfo

37、rmance cat-egory of the pressure/flow characteristics of the shunt assemblytypically defined as “low,”“ medium,” “high,” etc., the limits ofwhich are defined by the manufacturer.3.1.20 nonmodifiable connectionsee preassembled con-nection.3.1.21 one-piece hydrocephalus shunt assemblycompletesterile,

38、single-use hydrocephalus shunt consisting of an inflowcatheter integral with a pressure-activated or flow-controllingdevice or combination of devices and an integral outflowcatheter.3.1.22 on-off devicean accessory component specificallydesigned to permit alternate opening and closing of the shuntsy

39、stem upon external activation.3.1.23 packagingthe protective wrapping of shunt sys-tems or components:3.1.23.1 inner containerthe packaging 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,car

40、ton, or other container that may contain one or more unitcontainers. The packaging that envelopes the inner containersuch that sterility 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 outerc

41、ontainer.3.1.23.5 transit containera package, carton, or other con-tainer that may contain one or more unit containers used toprotect the 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 procedur

42、e-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 shuntassembly the components of which are preassembled at thetime of manufacture and are intended to be permanently fixedand not modified during a surgical procedu

43、re (for example, thesite where the valve is chemically bonded or mechanicallyjoined to tubing).3.1.25 preimplantation testa test that is performed on theshunt assembly in the operating room prior to implantation.3.1.26 pressure/flow grapha graphic representation of thecomposite performance character

44、istics of a population of flowimpedance devices.3.1.27 production line bench flow testa test method usedby the manufacturer to verify that 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

45、ceph-alus shunt assembly that is inserted into the cerebral ventriclesor any other site in the craniospinal axis to provide access to afluid compartment of the central nervous system (for example,into a lateral ventricle) and therefore constitutes the inflowpathway for the diversion of fluid through

46、 a shunt system.3.1.29 radiopacitythe X-ray absorption properties thatallow a shunt component to have clear and permanent visual-ization fluoroscopically 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 t

47、he correspondingrequirements will be invoked when the performance of themedical device will be questioned. The manufacturer need notuse this referee test method in the usual inspection and qualitycontrol.3.1.31 refluxa flow of fluid within a hydrocephalus shunttowards the cerebral ventricles or cere

48、brospinal 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 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

49、.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 protection.3.1.37 sterilizedterm used to denote an object that hasbeen subjected to a validated sterilization process.3.1.38 test specimena device or sample of devices