Oxygen concentrators for medical use - Safety requirements

رقم المستند: NL ISO 8359 : 2010
القطاع: Health Care Technology
TC: NL TC 3001
ICS: 11.040.10
NOTE 1 See the rationale in annex P. IS0 8359 is one of a series of International Standards based on IEC 601-I. In IEC 601-I (the “General Standard”), this type of International Standard is referred to as a “Particular Standard”. As stated in 1.3 of IEC 601-I :1988, the requirements of this International Standard take precedence over those of IEC 601-I. The scope and object given in clause 1 of IEC 601-I :I 988 apply, except that 1.1 shall be replaced by the following: This International Standard specifies safety requirements for continuous-flow oxygen concentrators, as defined in 1.3.8 (in this International Standard). This International Standard does not apply to oxygen concentrators in- tended to supply gas to several patients via a piped medical gas installation or to those intended for use in the presence of flammable anaesthetic and/or cleaning agents. The scope of this International Standard is not restricted to membrane oxygen concentrators and pressure swing absorbers (see Introduction), as alternative methods of concentrating oxygen may become available and it is not intended that this International Standard should restrict future developments.