BS EN 80601-2-30:2010 Medical electrical equipment. Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
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.
This standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for
this ME EQUIPMENT and its ACCESSORIES, including the requirements for the accuracy of a
DETERMINATION.
This standard covers electrically-powered intermittent, indirect measurement of the BLOOD
PRESSURE without arterial puncture, ME EQUIPMENT with automatic methods for estimating
BLOOD PRESSURE, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT.
Requirements for indirect measurement of the BLOOD PRESSURE without arterial puncture
ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in
conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE
(NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1.
BS EN 80601-2-30:2010 history
2015BS EN 80601-2-30:2010+A1:2015 Medical electrical equipment-Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
2010BS EN 80601-2-30:2010 Medical electrical equipment. Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
2000BS EN 60601-2-30:2000 Medical electrical equipment. Particular requirements for safety. Particular requirements for safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment