Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
|Publication Date:||1 May 2011|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
IEC 60601-1:2005, Clause 1 applies, except as follows: Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT: - intended to be attended by a professional OPERATOR for those PATIENTS who are dependent on mechanical ventilation; and NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM. - intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility.