CEI UNI EN ISO 80369-1
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
|Publication Date:||1 March 2019|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
|ICS Code (Transfusion, infusion and injection equipment):||11.040.20|
This document specifies general requirements for SMALL-BORE CONNECTORS, which convey liquids or gases in healthcare APPLICATIONS. These SMALL-BORE CONNECTORS are used in MEDICAL DEVICES or ACCESSORI
This document also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are intended to be used.
These healthcare fields include, but are not limited to:
- BREATHING SYSTEMS and driving gases;
- limb cuff inflation;
- intravascular or hypodermic.
This document provides the methodology to assess NON-INTERCONN
This document does not specify requirements for the MEDICAL DEVICES or ACCESSORI
NOTE 1 Clause 7 allows for additional designs of SMALL-BORE CONNECTORS for new APPLICATIONS for inclusion in the ISO 80369 series.
NOTE 2 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in the ISO 80369 series into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICES standards. It is expected that when the relevant particular MEDICAL DEVICES standards are revised, the risks associated with changing to the new SMALL-BORE CONNECTORS as specified in the ISO 80369 series of standards will be considered.
NOTE 3 The CONNECTORS specified in the ISO 80369 series are intended for use only in their specified APPLICATION. Use of these CONNECTORS for other APPLICATIONS increases RISK that a hazardous misconnection could occur.
NOTE 4 MANUFACTURERS and RESPONSIBLE ORGA
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.