prEN ISO 80369-2

Small bore connectors for liquids and gases in healthcare applications - Part 2 - Connectors for respiratory applications

General information

40.98   Project deleted   Sep 12, 2019

CEN/CENELEC

CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

Scope

This part of ISO 80369 specifies requirements for small-bore connectors intended to be used for connections in breathing systems applications and driving gases applications of medical devices and accessories that contain or directly or indirectly convey liquids or gases to or from a patient or to provide driving power to medical devices or accessories.
This part of ISO 80369 does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.

NOTE Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices, medical systems or accessories, even if currently not required by the relevant particular device standards. It is expected that when the relevant particular device standards are revised, requirements for small-bore connectors, as specified in this part of ISO 80369, will be included.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

NOW

ABANDON
prEN ISO 80369-2
40.98 Project deleted
Sep 12, 2019