BS EN ISO 10651-2:2009

BS EN ISO 10651-2:2009 Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Home care ventilators for ventilator-dependent patients
BS EN ISO 10651-2 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment, are frequently used in locations where driving power is not reliable, and are often supervised by non-healthcare personnel with different levels of training. BS EN ISO 10651-2 does not apply to cuirass and “iron-lung” ventilators. BS EN ISO 10651-2 does not apply to ventilators intended only to augment the ventilation of spontaneously breathing patients. The requirements of this part of ISO 10651 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements Contents of BS EN ISO 10651-2:

Foreword Introduction
Scope Normative references
Terms and definitions General requirements and requirements for tests
Classification Identification, marking and documents Power input Basic safety categories
Removable protective means
Environmental conditions
General
Requirements related to classification
Limitation of voltage and/or energy
Enclosures and protective covers
Separation Protective earthing, functional earthing and potential equalization
Continuous leakage currents and patient auxiliary currents
Dielectric strength Mechanical strength
Moving parts Surfaces, corners and edges Stability in normal use Expelled parts Vibr...