99.60 Withdrawal effective Dec 12, 2012
CEN
CEN/TC 215 Respiratory and anaesthetic equipment
European Norm
11.040.10 Anaesthetic, respiratory and reanimation equipment
Withdrawn
ISO 8835-5:2004 specifies particular requirements for the essential performance of anaesthetic ventilators (as defined in 3.1). ISO 8835-5:2004 is applicable to anaesthetic ventilators which are always a component of an anaesthetic system and are intended to be continuously attended by an operator.
ISO 8835-5:2004 is not applicable to anaesthetic ventilators intended for use with flammable anaesthetics, as determined by Annex BB.
The requirements of ISO 8835-5:2004 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.
This Scope is additional to the Scope given in IEC 60601-1:1988, Clause 1, except as noted above.
Legislation related to this standard
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
WITHDRAWN
EN ISO 8835-5:2004
WITHDRAWN
EN ISO 8835-5:2004/AC:2004
WITHDRAWN
EN ISO 8835-5:2004/AC:2006
WITHDRAWN
EN ISO 8835-5:2009
99.60
Withdrawal effective
Dec 12, 2012
WITHDRAWN
EN ISO 80601-2-13:2012
