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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 3-117: AAMI / ANSI / ISO 81060-2 Second edition 2013-05-01, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. (Cardiovascular)

Date of Standard: 2013. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 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:
Non-invasive Blood Pressure Monitors
Processes Affected:
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard, except for the following clauses:

Clause 5.1.6 Special patient populations, Lines 178- & 179;

Clause Data analysis, Examples 3 & 6;

Clause Data analysis, Examples 3 & 6;

Clause 5.2.5 Additional requirements for sphygmomanometer intended for use in exercise stress testing environments;

Clause 5.2.6. Additional requirements for a sphygmomanometer intended for use in ambulatory monitoring;

Clause Sphygmomanometers intended for use in adults, adolescents or children, Notes 1 & 2; and,

Clause 6.1.6 Special patient populations.

Transition Period:
FDA recognition of AAMI/ANSI/ISO 81060-2:2009 is hereby superseded by recognition of AAMI/ANSI/ISO 81060-2: Second edition 2013-05-01, Non-sphygmomanometers - Part 2: Clinical validation of automated measurement type. However, FDA will continue to accept declarations of conformity, in support of premarket submissions, to AAMI/ANSI/ISO 81060-2:2009 until December 31, 2013. After this transitional period, declarations of conformity to AAMI/ANSI/ISO 81060-2:2009 will not be accepted.
Related CFR Citations and Product Codes:
Device Name Device
§870.1130 System, Measurement, Blood-Pressure, Non-Invasive Class 2 DXN
Relevant Guidance:
Non-invasive Blood Pressure (NIBP) Monitor Guidance (version 1.0 issued March 10,1997)
FDA Technical Contacts:
 Charles Ho, Ph.D.
  10903 New Hampshire Avenue Building 66, Room 1318
  Silver Spring MD 20993
  email: charles.ho@fda.hhs.gov
 Sandy Weininger
  10903 New Hampshire Avenue Building 62, Room 4212
  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