scope:

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC 62D, Electromedical equipment. The draft was circulated for voting to the national bodies of both ISO and IEC.

ISO 80369 consists of the following parts, under the general title Small-bore connectors for liquids and gases in healthcare applications:

- Part 1: General requirements

- Part 2: Connectors for breathing systems and driving gases applications

- Part 3: Connectors for enteral applications

- Part 5: Connectors for limb cuff inflation applications

- Part 6: Connectors for neuraxial applications

- Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications

- Part 20: Common test methods