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

80601-2-30:2009 & A1:2013

Standard Organization: ANSI AAMI IEC

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

Recognition NumberCardiovascular
Recognition Date2019-01-14
Recognition List051
Recognition Number3-123
Extent Partial recognition. The following part(s) of the standard is (are) not recognized Clause 201.12.1.107 Reproducibility of the blood pressure determination;
Clause 201.15.3.5.101 Shock and vibration for other than transport;
Clause 201.15.3.5.102 Shock and vibration for transport;
Clause 201.104 Maximum inflation time;
Clause 201.105.3.1 General;
Clause 201.105.3.2 Normal condition; and
Clause 211.8.3.1 Ingress of water or particulate matter into ME Equipment.
Standards Orgs IEC International Electrotechnical Commission http://www.iec.ch/
STG Cardiovascular
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. Clauses 201.12.1.107, 201.15.3.5.101, 201.15.3.5.102, 201.104, 201.105.3, 201.105.3.2, and 211.8.3.1 are conflict with an established guideline, see section 10 of the 2017 ACC/AHA Guideline listed below.

Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§870.1130 System, Measurement, Blood-Pressure, Non-Invasive Class 2 DXN

FDA Guidance:

Whelton. P.K., Carey, R.M., Aronow, W.S., Casey, D.E. Jr, Collins, K.J., Dennison, Himmelfarb C., DePalma, S.M., Gidding, S., Jamerson, K.A., Jones, D.W., MacLaughlin, E.J., Muntner, P., Ovbiagele, B., Smith, S.C. Jr, Spencer, C.C., Stafford, R.S., Taler, S.J., Thomas, R.J., Williams, K.A. Sr, Williamson, J.D., and Wright, J.T. Jr. (2018). ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Journal of the American College of Cardiology, 71:e127-248.

Non-Invasive Blood Pressure (NIBP) Monitor Guidance, Issued March 1997.

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