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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 3-167
Standard
ISO  TS 81060-5 First edition 2020-02
Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
Scope/Abstract
This document specifies requirements for the repeatability and reproducibility of non-invasive blood pressure (NIBP) simulators intended to test automated sphygmomanometers utilizing the oscillometric non-continuous method only.

In addition, the pulse rate set on the NIBP simulator is tested.

This document is not intended to relate the signals, generated by the NIBP simulator, to the oscillometric signal recorded in a cuff attached to a human. It does not intend to test the interaction between the NIBP simulator and the tested automated sphygmomanometer (e.g. the agreement of the set values of the NIBP simulator and the displayed values of the tested automated sphygmomanometer or the properties of the cuff and tubing, such as design or elastic properties).

NOTE 1 These parameters can be tested separately in a clinical investigation or by using different special test setups.

This document does not check whether or not the NIBP simulator is able to test the accuracy of the absolute blood pressure value of oscillometric automated sphygmomanometers.

NOTE 2 Usually this is tested by a clinical investigation according ISO 81060-2 or other protocols.

This document is applicable to NIBP simulators testing automated sphygmomanometers for adults, children and neonates at the upper arm, thigh etc. and automated sphygmomanometers measuring at the wrist.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.1130 System, Measurement, Blood-Pressure, Non-Invasive Class 2 DXN
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Non-Invasive Blood Pressure (NIBP) Monitor Guidance, Issued March 1997.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Kimberly Crowley
  CDRH/OPEQ/OHTII
  301-796-6017
  Kimberly.Crowley@fda.hhs.gov
 Charles Ho
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-6320
  charles.ho@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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