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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 3-152
Standard(Included in ASCA pilot)
IEC 80601-2-30 Edition 1.1 2013-07
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
U.S. Identical Adoption
ANSI AAMI IEC 80601-2-30:2009 & A1:2013 (R2016)
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Scope/Abstract
This International Standard applies to the basic safety and essential performance of automated sphygmomanometers, hereafter referred to as ME equipment, which by means of an inflatable cuff, are used for intermittent indirect measurement of the blood pressure without arterial puncture.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
202.6.2.3.1 Requirements

201.7.9.2.13 Maintenance

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.

This standard is recognized in part because:
Section 202.6.2.3.1 is in conflict with another recognized standard, see Table 4 in IEC 60601-1-2 listed below.
Section 201.7.9.2.13 is in conflict with a test method and/or specification that is not scientifically acceptable, see article listed below.
Transition Period
FDA recognition of 80601-2-30 Edition 1.1 2013-07 [Rec# 3-152] will be superseded by recognition of IEC 80601-2-30 Edition 2.0 2018-03 [Rec# 3-123]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-152] until July 11, 2021. After this transition period, declarations of conformity to [Rec# 3-152] will not be accepted.
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*
1. IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

2. Linnet K., (1999). Necessary sample for Method Comparison Studies Based on Regression Analysis, Clinical Chemistry, 45(6): 882-894.

3. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
FDA Technical Contacts
 Charles Ho
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-6320
  charles.ho@fda.hhs.gov
 Sandy Weininger
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2582
  sandy.weininger@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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