EN ISO 17510-2:2009

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

Publication date:   Aug 21, 2009

General information

99.60 Withdrawal effective   Feb 19, 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 17510-2:2007 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.

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WITHDRAWN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 17510-2:2007

NOW

WITHDRAWN
EN ISO 17510-2:2009
99.60 Withdrawal effective
Feb 19, 2020

REVISED BY

PUBLISHED
EN ISO 17510:2020

Relations

Adopted from ISO 17510-2:2007 IDENTICAL