FORMAT
BOOKS
PACKAGES
EDITION
PUBLISHER
CONTENT TYPE
Act
Admin Code
Announcements
Bill
Book
CADD File
CAN
CEU
Charter
Checklist
City Code
Code
Commentary
Comprehensive Plan
Conference Paper
County Code
Course
DHS Documents
Document
Errata
Executive Regulation
Federal Guideline
Firm Content
Guideline
Handbook
Interpretation
Journal
Land Use and Development
Law
Legislative Rule
Local Amendment
Local Code
Local Document
Local Regulation
Local Standards
Manual
Model Code
Model Standard
Notice
Ordinance
Other
Paperback
PASS
Periodicals
PIN
Plan
Policy
Product
Program
Provisions
Requirements
Revisions
Rules & Regulations
Standards
State Amendment
State Code
State Manual
State Plan
State Standards
Statute
Study Guide
Supplement
Technical Bulletin
All
|
Description of ASTM-F647 2006ASTM F647 - 94(2006)Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical ApplicationActive Standard ASTM F647 | Developed by Subcommittee: F04.31 Book of Standards Volume: 13.01 ASTM F647Significance 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. 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. 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 1The 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.
ASTM Standards 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 Keywords anti-sipon device; bio-compatibility; compatibility; hydrocephalus; magnetic resonance imaging (MRI); shunt; shunt assembly; ICS Code ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics) DOI: 10.1520/F0647-94R06 ASTM International is a member of CrossRef. ASTM F647This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
Some features of MADCAD.com ASTM Standards Subscriptions are: - Immediate Access: As soon as the transaction is completed, your ASTM Standards Subscription will be ready for access.
For any further information on MADCAD.com ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
GROUPS
|