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: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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]

Description

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

Additional information

Standard Title	F647-94(2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
Published Code	ASTM
Publication Date	2006
Pages Count	12
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

Preview PDF


PDF Format	Searchable	Printable	Preview Now

ASTM-F647 2006

PDF Catalog

Related products