AS IEC 60601.1.11:2017

AS IEC 60601.1.11:2017 PDF

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

The objective of this Standard is to specify requirements for the basic safety and essential performance of medical electrical (ME) equipment and ME systems for use in the home healthcare environment. It applies regardless of whether the ME equipment or ME system is intended for use by a lay operator or by trained healthcare personnel.

This Standard is identical with, and has been reproduced from IEC 60601-1-11:2015 (ED. 2), Medical electrical equipment, Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.