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 Noninvasive Sphygmomanometers

80601-2-30:2009 & A1:2013 (R2016)

Standard Organization: ANSI AAMI IEC

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

Recognition NumberCardiovascular
Recognition Date2018-09-17
Recognition List050
Recognition Number3-152
Extent 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

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. 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.

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:

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.

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

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