Advice from the BP Measurement Experts
If you're a medical device developer or active in the design process, you've probably been involved with creating a list of "must have" and "nice to have" features and requirements for a new or updated medical device. Some come from market feedback, industry trends, competitor analysis, R&D and others come from medical equipment Regulatory standards. When it comes to safety and meeting regulatory standards, this is always in the mandatory column. With several deadlines looming on the horizon, meeting the latest 3rd edition standards as well as being RoHS compliant are on almost everyone's must have list when starting a new project. So whether you are developing your own NIBP or purchasing OEM NIBP modules, you now have new requirements that need to be a part of your design not only in hardware and software but also in the product's technical documentation.
A major change from “2nd edition” is the high emphasis on risk management and essential performance.
"3rd edition" loosely refers to the 3rd edition of IEC 60601-1 (general electrical medical equipment standard) and associated revisions of collateral and particular standards. A major change from "2nd edition" is the high emphasis on risk management and essential performance. Development and risk management now go hand-in-hand (more so than before) and are threaded together with the requirements in ISO 14971 – Application of risk management to medical devices. For NIBP, new standards exist which are IEC 80601-2-30 - Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, ISO 81060-1 - Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type and ISO 81060-2 - Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. Additionally, alarm requirements have been gathered into collateral standard IEC 60601-1-8 and new standards have been created for Home Healthcare (IEC 60601-1-11) and Usability (IEC 60601-1-6) that will drive NIBP design.
Several of these standards are based on previous NIBP standards but also include new requirements that must be addressed by the NIBP developer. I want to highlight eight new 3rd edition requirements specific to automated non-invasive blood pressure that may influence how you design your product. In this blog, I cover the first four.
Since I'm primarily involved with our OEM module products, I get a lot of questions about how 3rd edition affects our customers in relation to our NIBP modules. I've covered the first 4 new NIBP requirements that often come up in those discussions. Next week, I will address the second half so please check back for my exciting conclusion! In the meantime, if you have any questions about these first 4 requirements, please leave a comment below.