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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 17-12
ISO  7197 Third edition 2006-06-01
Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]
ISO 7197:2006 specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs.

For manufacturing, ISO 7197:2006 defines the mechanical and technical requirements. This International Standard defines the technical information of the valve, to be given by the manufacturer. In respect to the different principles of the valve types, specific characteristics are defined for each group as declared by the manufacturer.

The benefit of ISO 7197:2006 for the surgeon and the patient is to understand the information given by the manufacturer and to obtain standardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to define the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§882.4060 Cannula, Ventricular Class 1 HCD
§882.4100 Catheter, Ventricular Class 2 HCA
§882.4545 Instrument, Shunt System Implantation Class 1 GYK
§882.5550 Shunt, Central Nervous System And Components Class 2 JXG
Relevant FDA Guidance and/or Supportive Publications*
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.
Guidance for Industry: Pyrogens and Endotoxins Testing: Questions and Answers, Issued June 2012.
USP 40-NF35:2017, <85> Bacterial endotoxins test.
USP 39-NF34:2016, <151> Pyrogen test

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Leigh Anderson
 Gregg Kittlesen
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.