EN ISO 17510-1:2009

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

Publication date:   Aug 21, 2009

General information

99.60 Withdrawal effective   Nov 25, 2020

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

ISO 17510-1:2007 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.
ISO 17510-1:2007 applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates.
Jet and very high frequency ventilation and oscillation are not considered in ISO 17510-1:2007.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 17510-1:2007

NOW

WITHDRAWN
EN ISO 17510-1:2009
99.60 Withdrawal effective
Nov 25, 2020

REVISED BY

PUBLISHED
EN ISO 80601-2-70:2020

Relations

Adopted from ISO 17510-1:2007 IDENTICAL