10.99 New project approved Nov 4, 2026
CEN
CEN/TC 215 Respiratory and anaesthetic equipment
European Norm
Standardisation of the particular requirements for basic safety and essential performance of medical devices and their accessories that connect to or are inserted into the airways of patients, including devices used to visualize a patient's supraglottic airway, and those devices that provide the interface between the patient and atmosphere or gas from a supply device.
Examples include tracheal and tracheostomy tubes, supralaryngeal and oropharyngeal airways, laryngoscopes, connectors, breathing system tubing, respiratory therapy tubing, nebulizers, breathing filters, suction catheters, fire-activated oxygen shut off devices.
Legislation related to this standard
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
IN_DEVELOPMENT
prEN ISO 9360-3
10.99
New project approved
Nov 4, 2026