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SRPS EN ISO 8359:2011

Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

Jan 31, 2011
95.99   Withdrawal of Standard   Feb 28, 2018

General information

95.99     Feb 28, 2018

ISS

Z076

European Norm

11.040.10  

English  

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Scope

Based on IEC 601-1. Specifies safety requirements for oxygen concentrators. Does not apply to oxygen concentrators intended to supply gas to several patients via a medical gas pipeline system. Replaces the first edition.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
2007/47/EC

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

Directive 2007/47/EC

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 8359:2011
95.99 Withdrawal of Standard
Feb 28, 2018

REVISED BY

WITHDRAWN
SRPS EN ISO 80601-2-69:2015

Related project

Adopted from EN ISO 8359:2009

Adopted from ISO 8359:1996 IDENTICAL