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ASTM
ASTM F 647 : 1994 : R2014

ASTM F 647 : 1994 : R2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application

Available format(s)

Hardcopy , PDF

Superseded date

20-10-2022

Language(s)

English

Published date

27-11-2014

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2015 Specifies 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.

1.1This 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.

1.2Devices 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.

1.3Limitations—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.

1.4The 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.

1.5This 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.

Committee
F 04
DocumentType
Standard Practice
Pages
12
ProductNote
Reconfirmed 2014
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 640 : 2020 Standard Test Methods for Determining Radiopacity for Medical Use

ASTM F 56 : 1982 Specification for Stainless Steel Sheet and Strip for Surgical Implants (Withdrawn 1989)
ASTM F 897 : 1984 : R1997 : EDT 1 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
ASTM F 90 : 2014 : REDLINE Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
ASTM F 469 : 1978 Practice for Assessment of Compatibility of Nonporous Polymeric Materials for Surgical Implants with Regard to Effect of Materials on Tissue (Withdrawn 1987)
ASTM F 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
ASTM F 55 : 1982 Specification for Stainless Steel Bar and Wire for Surgical Implants (Withdrawn 1989)
ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use

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