AS IEC 60601.1.10:2017

AS IEC 60601.1.10:2017 PDF

The objective of this Standard is to improve the environmental impact for the entire range of medical equipment (ME), taking into account all stages of the product life cycle: product specification, design, manufacturing, sales, logistics, installation, use and end of life management.

This Standard was prepared by the Standards Australia Committee HE-003, Medical Electrical Equipment.

The objective of this Standard is to specify 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 (ME) equipment and ME systems to control a physiologic variable.

This Standard is identical with, and has been reproduced from IEC 60601-1-10:2007+AMD1:2013 CSV (ED. 1.1), 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.