BS EN IEC 80601-2-30:2019

What is BS EN IEC 80601-2-30 - Automated non-invasive sphygmomanometers?  

BS EN IEC 80601 discusses medical electrical equipment. BS EN IEC 80601-2-30 layouts 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 non-continuous indirect estimation of the blood pressure without arterial puncture. 

BS EN IEC 80601-2-30 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. 

BS EN IEC 80601-2-30 covers automatic electrically powered ME equipment used for the intermittent, indirect estimation of the blood pressure without arterial puncture, including blood pressure monitors for the home healthcare environment. 

Requirements for indirect estimation 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 [2]. 

Note: Equipment that performs indirect determination of the blood pressure without arterial puncture does not directly measure the blood pressure. it only estimates the blood pressure. 

Who is BS EN IEC 80601-2-30 - Automated non-invasive sphygmomanometers for? 

BS EN IEC 80601-2-30 on automated non-invasive sphygmomanometers is useful for: 

• Automated non-invasive sphygmomanometers manufacturers 
• Medical laboratories  
• Regulatory authorities 

Why should you use BS EN IEC 80601-2-30 - Automated non-invasive sphygmomanometers? 

Automated sphygmomanometer a ME equipment is used for the non-invasive estimation of the blood pressure by utilizing an inflatable cuff, a pressure transducer, a valve for deflation, and/or displays used in conjunction with automatic methods for determining blood pressure.  

BS EN IEC 80601-2-30 best practice guidelines help you with essential performance requirements and protection against electrical hazards, mechanical hazards, unwanted and excessive radiation hazards, excessive temperatures, and other hazards for automated non-invasive sphygmomanometers.  

This improves the performance and safety of automated non-invasive sphygmomanometers. In addition, minimizes hazards to the patient and operator. 

What’s changed since the last update? 

BS EN IEC 80601-2-30:2019 supersedes IEC 80601-2-30:2009, which has been withdrawn. BS EN IEC 80601-2-30:2019 has some technical changes with respect to IEC 80601-2-30:2009. These includes: 

• Alignment with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2012 [1] 1, and with IEC 60601-1-2:2014 and IEC 60601-1-11:2015 
• Referencing IEC 60601-1-10:2007 and IEC 60601-1-12 
• Changing an OPERATOR-accessible CUFF-sphygmomanometer connector from not compatible with the ISO 594 series to compatible with the ISO 80369 series 
• Added additional requirements for public self-use sphygmomanometers 
• Added a list of primary operating functions