DS/EN ISO 10651-2:2009 ( Withdrawn )

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients


Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.62
Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

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.


Number of pages: 52

Published: 2009-05-18

Date of approval: 2009-05-01

Date of withdrawal: 2015-10-01

International relationships : EN ISO 10651-2:2009 IDT ISO 10651-2:2004 IDT

ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment

Item number: M233871


Committees

Committee

  • CEN/TC 215
  • ISO/TC 121/SC 3

Danish committee

DS/S-104