Shopping Cart

No products in the cart.

ASTM-F647 2006

$44.96

F647-94(2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application

Published By Publication Date Number of Pages
ASTM 2006 12
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

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.

PDF Catalog

PDF Pages PDF Title
1 Scope
2 Referenced Documents
Terminology
4 Significance and Use
Materials
General Requirements for Complete Shunts and Components
6 Additional Requirements for Implantable Accessory Devices Supplied Separately
7 Keywords
A1. TEST METHOD FOR DETERMINING RADIOPACITY OF SHUNT COMPONENTS
A1.1 Scope
A1.2 Significance and Use
A1.3 Apparatus and Materials
A1.4 Test Specimens
A1.5 Control Specimens
A1.6 Apparatus/Procedure
A1.7 Acceptance Criterion
A1.8 Report of Results
A1.9 Precision and Bias
8 A2. REFERENCE METHOD FOR DETERMINING PRESSURE AND FLOW CHARACTERISTICS
A2.1 Scope
A2.2 Summary of Test Method
A2.3 Significance and Use
A2.4 Test Medium
A2.5 Apparatus
A2.6 Test Specimens
A2.7 Procedure
9 A2.8 Interpretation of Results
A2.9 Report
A3. REFERENCE TEST METHOD FOR REFLUX
A3.1 Principle
A3.2 Reagent
A3.3 Apparatus
A3.4 Test Specimens
A3.5 Procedure
10 X1. SUGGESTED TEST METHOD FOR DURABILITY
X1.1 General
X1.2 Principle
X1.3 Reagent—Test Fluid
X1.4 Apparatus
X1.5 Test Specimens
X1.6 Procedure
11 X1.7 Report
X2. GUIDANCE ON MATERIALS
X2.1
X2.2
X2.3
X2.4
X2.5
X2.6
X2.7
ASTM-F647 2006
$44.96