FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International Standard IEC 80369‑5 has been prepared by a Joint Working Group of subcommittee 62D: Electromedical equipment of IEC technical committee 62: Electrical equipment in medical practice, ISO technical committee 210, Quality management and corresponding general aspects for medical devices and CEN/CENELEC TC3/WG 2, Smallbore connectors.

The text of this standard is based on the following documents:

FDIS	Report on voting
62D/1306/FDIS	62D/1329/RVD

Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 23 P members out of 23 having cast a vote.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

A list of all parts in the International Standard 80369 series, published under the general title Small-bore connectors for liquids and gases in healthcare applications, can be found on the IEC and ISO websites.

In this standard, the following print types are used:

— Requirements and definitions: roman type.
— Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type.
— Terms defined inClause 3of this standard or as noted in the Index of defined terms: small capitals.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb:

— “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.

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.

NOTE The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committees that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication.

The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to the specific publication. At this date, the publication will be

• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

The contents of the corrigenda 1 (2017) and 2 (2021) have been included in this copy.

BS EN 80369-5:2016

Small-bore connectors for liquids and gases in healthcare applications - Connectors for limb cuff inflation applications

Current

Published:

30 Jun 2021