BS EN 60601-1-10:2008+A1:2015

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