• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Non-invasive Blood Pressure Monitors
Processes Affected:
510(k)
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 5.2.4.1.2 Data analysis, Examples 3 & 6;

Clause 5.2.4.2.2 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 6.1.3.1 Sphygmomanometers intended for use in adults, adolescents or children, Notes 1 & 2; and,

Clause 6.1.6 Special patient populations.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§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.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1318
  Silver Spring MD 20993
  301/796-6320
  email: charles.ho@fda.hhs.gov
 Sandy Weininger
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 4212
  Silver Spring MD 20993
  301/796-2582
  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
-
-