Full Description 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 690
ISO 26782
IEC 60027 (all parts)
ISO/IEC TR 10000-1
ISO 23747
ISO/IEC Guide 63:2012
IEC 60601-1-8:2006+AMD1:2012
ISO/IEEE 11073-10101:2004+Amd1:2017
ISO 80000 (all parts)
ISO 17510
ISO 80601-2-72
ISO 5356-1
ISO 860
ISO/IEC Guide 51
ISO 80601-2-79
IEC 60601-1:2005+AMD1:2012
ISO 10651-4
ISO 10651-3
ISO 80601-2-67
ISO/TS 8000-1
ISO 10241-1
ISO 10241-2
ISO 80601-2-13:2011+Amd1:2015+Amd2:2018
ISO 80601-2-80
ISO 80601-2-70:2015
ISO 80601-2-12:2011/Cor 1:2011
ISO 4135:2001
ISO 704:2009
ISO 14971:2007
All current amendments available at time of purchase are included with the purchase of this document.