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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 3-123
Standard(Included in ASCA pilot)
IEC 80601-2-30: Edition 2.0 2018-03
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 80601-2-30:2018
Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type 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:
Clause 211.8.3.1 Ingress of water or particulate matter into ME equipment.
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. Contact FDA regarding the use of the device prior to using this standard to support claims for use during patient transport, ambulatory monitoring, stress and/or exercise testing.

Clause 211.8.3.1 does not provide a rationale for the change from IP21 to the less stringent IP20. This is inconsistent with ambulatory ME such as IEC 60601-2-27 Clause 201.11.65 and IEC 80601-2-61 Clause 201.7.2.9.101 IP Classification, and Clause 201.11.6.5.101 Additional requirements for ingress of water or particular matter into ME equipment or ME System.
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FDA recognition of 80601-2-30 Edition 1.1 2013-07 [Rec# 3-152] will be superseded by recognition of IEC 80601-2-30 Edition 2.0 2018-03 [Rec# 3-123].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 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment -Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.

2. IEC 80601-2-61 Second edition 2017-12 Medical electrical equipment -Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

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
 Taddese, Biniyam
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  240-402-6570
  Biniyam.Taddese@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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