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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 028 Date of Entry 03/16/2012 
FR Recognition Number 3-96
Standard
ISO  81060-1 First edition 2007-12-01
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
Identical Adoption
ANSI AAMI ISO 81060-1:2007/(R)2013
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
Scope/Abstract
ISO 81060-1:2007 specifies requirements for non-automated sphygmomanometers and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation.

ISO 81060-1:2007 specifies requirements for the safety and essential performance, including effectiveness and labelling, for non-automated sphygmomanometers and their accessories, including test methods to determine the accuracy of non-invasive blood pressure measurement.

ISO 81060-1:2007 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.1120 Blood Pressure Cuff Class 2 DXQ
Relevant FDA Guidance and/or Supportive Publications*
Non-Invasive Blood Pressure (NIBP) Monitor Guidance, Issued March 1997.

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
 Charles Ho
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-6320
  charles.ho@fda.hhs.gov
 Kimberly Crowley
  CDRH/OPEQ/OHTII
  301-796-6017
  Kimberly.Crowley@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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