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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 3-122: ISO 81060-2 Second edition 2013-05-01, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. (Cardiovascular)

Date of Standard: 2013. 
Address of Standards Development Organization:
 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
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