Standard

NS-EN ISO 10651-2:2009

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Abstract

ISO 10651-2:2004 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. ISO 10651-2:2004 is intended to be used in conjunction with the General Standard IEC 60601-1:1988.ISO 10651-2:2004 is not applicable to cuirass and 'iron-lung' ventilators.ISO 10651-2:2004 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients.The requirements of ISO 10651-2:2004 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.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2009-04
  • Version: 1
  • Document type: NAT
  • ICS 11.040.10
  • National Committee SN/K 122

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EU law: 2007/47/EC

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