30.98 Project deleted Nov 9, 2020
CEN
CEN/TC 215 Respiratory and anaesthetic equipment
European Norm
This document specifies the dimensional characteristics of 23 mm tracheostoma connectors It also defines the functional requirements including test methods.
This document does neither specify the tracheostomy attachment system nor the tracheostomy accessories except for their connecting interface.
NOTE 1 Requirements on tracheostomy accessories, such as HME filter cassettes, tracheostomy valves, as well as attachment systems such as tracheostoma base plates will be covered by further standards.
This document does not cover 15 mm connectors for tracheal or tracheostomy tubes but includes 23 mm connectors for cannulae used for the rehabilitation of patients after laryngectomy.
NOTE 2 For 15 mm connectors for tracheal or tracheostomy tubes, see ISO 5361 and ISO 5366.
The field of application of the connectors specified in this document does not include breathing systems
or vaporizers.
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
ABANDON
prEN ISO 4770
30.98
Project deleted
Nov 9, 2020
