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
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.
Legislation related to this standard
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
WITHDRAWN
EN ISO 17510-2:2007
WITHDRAWN
EN ISO 17510-2:2009
99.60
Withdrawal effective
Feb 19, 2020
PUBLISHED
EN ISO 17510:2020