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SSH EN ISO 17510:2020

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

Aug 31, 2020

General information

60.60     Aug 31, 2020

DPS

DPS/KT 215

European Norm

11.040.10  

English  

Buying

Published

Language in which you want to receive the document.

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 directives

Directives related to this standards.

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WITHDRAWN
SSH EN ISO 17510-1:2009

WITHDRAWN
SSH EN ISO 17510-2:2009

NOW

PUBLISHED
SSH EN ISO 17510:2020
60.60 Standard published
Aug 31, 2020

Related project

Adopted from FprEN ISO 17510