DIN EN ISO 80601-2-72
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015); German version EN ISO 80601-2-72:2015
Medizinische elektrische Geräte - Teil 2-72: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten für vom Gerät abhängige Patienten (ISO 80601-2-72:2015); Deutsche Fassung EN ISO 80601-2-72:2015
Overview
The standard applies to ventilators intended primarily for use in home care. The ventilators according to this standard are intended for use by lay operators. They are used for patients who are dependent on mechanical ventilation. The standard replaces DIN EN ISO 10651-2:2011-06. In the course of the revision the standard was adapted to DIN EN 60601-1:2007-07 and IEC 60601-1-11:2015. The scope was extended to include accessories, provided that the accessories may affect basic safety and essential performance characteristics. In addition, the performance characteristics were revised and supplemented by further test methods. Requirements for functional connections to support remote connection have been included in the standard and supplemented by an informative annex on a data interface. Other changes mainly concern revisions to the requirements for labeling and manufacturer information. The standard has been prepared by CEN/TC 215 "Respiratory and anaesthetic equipment" (secretariat: BSI, United Kingdom), in collaboration with ISO/TC 121 "Anaesthetic and respiratory equipment" (secretariat: ANSI, USA) with the participation of German experts. At DIN, the German Institute for Standardization e. V., Working Committee NA 053-03-01 AA "Anästhesie und Beatmung" ("Anaesthesia and artificial respiration") at DIN Standards Committee Rescue Services and Hospital (NARK) is responsible.
Document: references other documents
Responsible national committee
NA 176-05-03 AA - Anaesthesia and artificial respiration
Responsible european committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Responsible international committee
ISO/TC 121/SC 3/JWG 12 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG: Home respiratory equipment
