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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Recognition 08/14/2015 
FR Recognition Number 17-4
Standard
ASTM F647-94 (Reapproved 2014)
Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
Scope/Abstract
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.

Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Clause 5.3 Biocompatibility (Polymeric Materials)
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Clause 5.3 is in conflict with existing published final guidance, see Section III and Table A.1 of the first guidance listed below.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§882.5550 Shunt, Central Nervous System And Components Class 2 JXG
§882.4545 Instrument, Shunt System Implantation Class 1 GYK
§882.4100 Catheter, Ventricular Class 2 HCA
§882.4060 Cannula, Ventricular Class 1 HCD
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological Evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."

Guidance for Industry: Pyrogens and Endotoxins Testing: Questions and Answers, Issued June 2012.

AAMI / ANSI ST72:2011/(R)2016, Bacterial Endotoxins - Test Methods, Routine Monitoring, and Alternatives to Batch Testing.

AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process.

USP 40-NF35:2017, <85> Bacterial endotoxins test.

USP 39-NF34:2016, <151> Pyrogen test
FDA Technical Contact
 Leigh Anderson
  FDA/OMPT/CDRH/ODE/DNPMD/NIDB/
  301-796-5613
  leigh.anderson@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Neurology
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