What is this standard about?
BS EN 60601-1-10 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems.
This part is a collateral standard and its objective is to outline requirements that are in addition to those of the general standard. It specifically covers physiologic closed-loop controllers and complements BS EN 60601-1.
Who is this standard for?
- Manufacturers of electrical medical equipment
- Suppliers of medical electronic equipment and components
- All healthcare facilities/hospitals/intensive care units
- Health and safety professionals
- Regulatory bodies
Why should you use this standard?
This part of the BS EN 60601 series specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC) as part of a physiologic closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems. This controls a physiologic variable, which can be a body chemistry such as blood glucose, a physical property such as a patient’s temperature or a pharmaceutical concentration. Use of PCLCs should improve patient safety and reduce healthcare costs.
What’s changed since the last update?
- The standard has been systematically reviewed by experts to ensure its continued market relevance
- It takes into account the advances and on-going developments in technical equipment, to ensure performance with acceptable risks under all clinical and physiologic conditions
- Equipment that incorporates a Programmable Electrical Medical System (PEMS) now applies to the requirements of Clause 14 of the general standard