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...
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