SS-EN-ISO-8359 Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/Amd 1:2012)

SS-EN-ISO-8359 - 2009/A1:2012 EDITION AMENDMENT - SUPERSEDED
Show Complete Document History

Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:


NOTE 1 See the rationale in annex P.ISO 8359 is one of a series of International Standards based on IEC 601-1. In IEC 601-1 (the "General Standard"), this type of International Standard is referred to as a "Particular Standard". As stated in 1.3 of IEC 601-1:1988, the requirements of this International Standard take precedence over those of IEC 601-1.The scope and object given in clause 1 of IEC 601-1:1988 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 intended 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 Introcuction), as alternative methods of concentrating oxygen may become available and it is not intended that this International Standard should restrict future developments.

To find similar documents by classification:

11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)


Medical devices. 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
ORDER



Designation Name

SS-EN ISO 8359:2009/A1:2012

Revision Level

2009/A1:2012 EDITION AMENDMENT

Status

Superseded

Publication Date

Aug. 6, 2012

Language(s)

English

Page Count

16

International Equivalent

EN ISO 8359:2009/A1:2012(IDT); ISO 8359:1996/Amd 1:2012(IDT)