1Key Takeaways
IEC 60601-1:1988, Clause 1 applies, except as follows.
Amendment:
This part of ISO 10651 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 w…
2Scope / Description
IEC 60601-1:1988, Clause 1 applies, except as follows.
Amendment:
This part of ISO 10651 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.
This part of ISO 10651 is not applicable to cuirass and “iron-lung” ventilators.
This part of ISO 10651 is not applicable 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.
5Citation Network
Referenced by BS EN ISO 10651-2:2009
IEC 60079-4
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8:2003
IEC 60601-1:1988
ISO 14937
ISO 14971
ISO 15001
6Frequently Asked Questions
What is 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 - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) is an international standard developed by British Standards Institution (BSI). IEC 60601-1:1988, Clause 1 applies, except as follows. Amendment: This part of ISO 10651 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventilators are...
What does BS EN ISO 10651-2:2009 cover?
This standard covers: IEC 60601-1:1988, Clause 1 applies, except as follows. Amendment: This part of ISO 10651 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...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of BS EN ISO 10651-2:2009?
The current published version is BS EN ISO 10651-2:2009, published on 2009-07-31. Always check for amendments or pending revisions.
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