This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation, including sleep-apnoea breathing-therapy equipment. It is applicable
— in lung ventilator and breathing-therapy device standards,— in health informatics standards,— for labelling on medical electrical equipment and medical electrical systems,— in medical electrical equipment and medical electrical system instructions for use and accompanying
documents,— for medical electrical equipment and medical electrical systems interoperability, and— in electronic health records.
This document is also applicable to those accessories intended by their manufacturer to be connected to
a ventilator breathing system or to a ventilator, where the characteristics of those accessories can affect
the basic safety or essential performance of the ventilator and ventilator breathing system.Cross References:ISO 690ISO 26782IEC 60027 (all parts)ISO/IEC TR 10000-1ISO 23747ISO/IEC Guide 63:2012IEC 60601-1-8:2006+AMD1:2012ISO/IEEE 11073-10101:2004+Amd1:2017ISO 80000 (all parts)ISO 17510ISO 80601-2-72ISO 5356-1ISO 860ISO/IEC Guide 51ISO 80601-2-79IEC 60601-1:2005+AMD1:2012ISO 10651-4ISO 10651-3ISO 80601-2-67ISO/TS 8000-1ISO 10241-1ISO 10241-2ISO 80601-2-13:2011+Amd1:2015+Amd2:2018ISO 80601-2-80ISO 80601-2-70:2015ISO 80601-2-12:2011/Cor 1:2011ISO 4135:2001ISO 704:2009ISO 14971:2007All current amendments available at time of purchase are included with the purchase of this document.