We need your consent to use the individual data so that you can see information about your interests, among other things. Click "OK" to give your consent.
Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
STANDARD published on 1.1.2000
Designation standards: ASTM F647-94(2000)
Note: WITHDRAWN
Publication date standards: 1.1.2000
SKU: NS-55998
The number of pages: 12
Approximate weight : 36 g (0.08 lbs)
Country: American technical standard
Category: Technical standards ASTM
Keywords:
anti-sipon device, bio-compatibility, compatibility, hydrocephalus, magnetic resonance imaging (MRI), shunt, shunt assembly, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
1. Scope | ||||||||||||||||||||
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. 1.5 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. |
||||||||||||||||||||
2. Referenced Documents | ||||||||||||||||||||
|
Do you want to make sure you use only the valid technical standards?
We can offer you a solution which will provide you a monthly overview concerning the updating of standards which you use.
Would you like to know more? Look at this page.
Latest update: 2025-07-09 (Number of items: 2 207 504)
© Copyright 2025 NORMSERVIS s.r.o.