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EVS-EN ISO 17510-2:2009

Sleep apnoea breathing therapy - Part 2: Masks and application accessories

General information
Withdrawn from 02.03.2020
Base Documents
ISO 17510-2:2007; EN ISO 17510-2:2009
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history

Status
Date
Type
Name
02.03.2020
Main
07.08.2009
Main
Main
EVS-EN ISO 17510-2:2007
This part of ISO 17510 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. Sleep apnoea breathing therapy equipment is covered by ISO 17510-1. See Figure A.1 for typical elements of the two parts of ISO 17510. This part of ISO 17510 does not cover oral appliances.
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EVS-EN ISO 17510-1:2009

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment
Withdrawn from 15.12.2020