IEC 60601-1-10 Closed Loop Controllers Testing
Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers
IEC 60601-1-10 Scope:
IEC 60601 1 10 and EN 60601 1 10 testing applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as medical electronic equipment and medical equipment systems. IEC 60601-1-10 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 electronic equipment and medical equipment systems to control a physiologic variable.
NOTE A physiologic variable can be a body chemistry (e.g. electrolytes, blood glucose), a physical property (e.g. patient temperature, electrophysiologic, hemodynamic), or a pharmaceutical concentration.
EN 60601-1-10 testing applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard does not specify:
- Additional mechanical requirements; or
- Additional electrical requirements.
IEC 60601-1-10 applies to a closed-loop controller (see Figure 1) that sets the controller output variable in order to adjust (i.e., change or maintain) the measured physiologic variable by relating it to the reference variable.
A closed-loop controller that maintains a physical or chemical variable, using feedback that is not measured from a patient, is outside the scope of this standard.
Keystone Compliance assists manufacturers with IEC 60601-1-10 and EN 60601-1-10 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601 1 lab needs.