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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 028 Date of Recognition 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
U.S. 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.
FDA Technical Contacts
 Charles Ho
  FDA/OMPT/CDRH/ODE/DCD/CDDB/
  301-796-6320
  charles.ho@fda.hhs.gov
 Sandy Weininger
  FDA/OMPT/CDRH/OSEL/DBP/
  301-796-2582
  sandy.weininger@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
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