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ILNAS-EN ISO 17510-2:2009 Edition 03/2009
Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)
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Abstract

ISO 17510-2:2007 applies to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient connection port of sleep apnoea breathing therapy equipment to a patient, and are used for the application of sleep apnoea breathing therapy, e.g. nasal masks, exhaust ports and headgear. ISO 17510-2:2007 does not cover oral appliances.

Status

Standard - Superseded

Origin

Technical Committee :
CEN/TC 215 : Respiratory and anaesthetic equipment

Directives

93/42/EEC : Medical devices
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

Implementation

start of the vote on the project      date of ratification (dor)    24/02/2009
end of the vote on the project      date of anouncement (doa)    30/06/2009
start of the vote on the final project    23/10/2008   date of publication (dop)    30/09/2009
end of the vote on the final project    23/01/2009   date of withdrawal (dow)    21/03/2010


Publication Official Journal
of the Grand-Duchy of Luxembourg
14/03/2011
Reference Mémorial A N° 47

Relations

Evolutions
ILNAS-EN ISO 17510:2020
FprEN ISO 17510

Relations to older standards
ILNAS-EN ISO 17510-2:2007

International Classification for Standards (ICS codes) :

11.040.10 : Anaesthetic, respiratory and reanimation equipment

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