60.60 Standard published Jun 3, 2026
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 | 11.040.20 Transfusion, infusion and injection equipment
This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient.
This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to:
— respiratory;
— enteral;
— limb cuff inflation;
— neural;
— intravascular or hypodermic;
— other use cases utilizing an ISO 80369-7 small-bore connector.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series.
NOTE Clause A.2 contains guidance or rationale for this Clause.
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
WITHDRAWN
EN ISO 80369-1:2018
PUBLISHED
EN ISO 80369-1:2026
60.60
Standard published
Jun 3, 2026
