FprEN ISO 17510

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories

General information

40.98   Project deleted   May 3, 2018

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

Scope

ISO 17510:2015 applies to masks and their 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 for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).

Related legislation

Legislation related to this standard

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

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 17510-2:2009

NOW

ABANDON
FprEN ISO 17510
40.98 Project deleted
May 3, 2018