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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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F55 Specification for Stainless Steel Bar and Wire for Surgical Implants
F56 Specification for Stainless Steel Sheet and Strip for Surgical Implants
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F469 Practice for Assessment of Compatibility of Nonporous Polymeric Materials for Surgical Implants with Regard to Effect of Materials on Tissue
F604 Specification for Silicone Elastomers Used in Medical Applications
F640 Test Methods for Determining Radiopacity for Medical Use
F897 Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)