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