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Standard

SN 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.

Products specifications

  • Standard from INB
  • Published:
  • Withdrawn:
  • Transition:
  • Effective:
  • Document type: EN
  • Pages
  • ICS: 11.040.10
  • Publisher: SNV
  • Distributor: SNV
  • National Committee: INB/NK 124

Legal references

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law:
Law referenceRestrictions
812.213
Designated under following EU law:
Law referenceRestrictions
Council Directive 93/42/EEC

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