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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 3-96: ISO 81060-1 First edition 2007-12-01, non-invasive sphygmomanometers - part 1: requirements and test methods for non-automated measurement type. (Cardiovascular)

Date of Standard: 2007. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Manual (non-automated) Non-invasive Blood Pressure Monitors, and Blood Pressure Cuffs
Processes Affected:
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard, except that instead of using IEC 60601-1:2005, 3rd edition, please use the FDA/CDRH recognized ANSI/AAMI ES 60601-1:2005 standard.
Related CFR Citations and Product Codes:
Device Name Device
§870.1120 Blood Pressure Cuff Class 2 DXQ
Relevant Guidance:
Non-invasive Blood Pressure (NIBP) Monitor Guidance (version 1.0 issued March 10, 1997)
FDA Technical Contacts:
 Charles Ho
  10903 New Hampshire Avenue WO66, RM1318
  Silver Spring MD 20993
  email: charles.ho@fda.hhs.gov
 Sandy Weininger
  10903 New Hampshire Avenue WO62 RM1210
  Silver Spring MD 20993
  email: sandy.weininger@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036