National foreword

This British Standard is the UK implementation of EN ISO 80369‑6:2025. It is identical to ISO 80369‑6:2025. It supersedes BS EN ISO 80369‑6:2016, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/210/5, Small Bore Connectors for Medical Devices.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2025.

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 document 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).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.

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

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for products with a health purpose including medical devices, in collaboration with Technical Committee IEC/SC 62D, Particular medical equipment, software, and systems, and with the European Committee for Standardization (CEN) Technical Committee CEN/CLC/JTC 3, Quality management and corresponding general aspects for medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 80369‑6:2016), which has been technically revised.

The main changes are as follows:

To ensure inclusive wording, the word “male” was replaced by “cone” and “female” replaced by “socket” throughout the document.
Compared to the first edition of this document, the word “neuraxial” has been replaced with “neural” throughout the document.
The materials requirements of Clause 5 were updated to include all applicable parts of the ISO 527 series.
All performance requirements of the first edition of this document utilized ISO 80369‑20:2015. This second edition references ISO 80369‑20:2024. To retain the backward compatibility with the first edition of this document, two of the ISO 80369‑20:2015 test methods were migrated into this document as Annex F and Annex G. Several informative passages related to these methods were similarly migrated into Annex A. Performance requirements 7.1.2 and 7.2 now reference the test methods of Annex F and Annex G, respectively. All other performance requirements reference the test methods of ISO 80369‑20:2024.
Tolerances of several connector dimensions in Annex B were modified. All changes are deemed backwards compatible, except for the pitch “p” which is now a dimensional requirement only and radius “r2” of Figure B.1, which is now normative. The figures were updated for clarity.
Annex C reference connector figures and dimensions were reviewed and modified to increase tolerances. All reference connectors manufactured to the requirements of the first edition of this document also conform to the modified figures of this document. The figures were updated for clarity.
Annexes E and F of the first edition of this document were removed as the small-bore connectors defined in this document have been verified against usability and design requirements.
Annex G of the first edition of this document and all Clause 4 references to non-interconnectability, including all residual misconnections / misconnection analysis, were moved to ISO 80369‑1:‑,¹ Annex E.
Annex H of the first edition of this document was removed as this content is included in ISO 80369‑1:‑, Annex B.
Annex J of the first edition of this document is now Annex H.
Remaining Annexes were renumbered accordingly.
The bibliography was revised to cite only documents and standards that are referenced informatively in this document.

A list of all parts in the ISO and IEC 80369 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

The small-bore connectors specified in this document conform with the non-interconnectability requirements of ISO 80369‑1:‑.

This document includes design and performance requirements for small-bore connectors for neural applications. Neural applications involve the use of medical devices intended to administer medications to neural sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.

NOTE 1 Sites for the neural application include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epidural, extradural, or peridural space. Neural application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the brachial plexus blocks or single nerve blocks. Neural application procedures include continuous infusion of wounds with local anaesthetic agents.

NOTE 2 For the purposes of this document, local anaesthesia injected hypodermically is not considered a neural application.

EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics.

It is possible that the small-bore connectors specified in this document are not suitable for some medical devices within this application.

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

In this document, the following verbal forms are used:

“shall” indicates a requirement;
“should” means that conformance with a requirement or a test is recommended but is not mandatory for conformance with this document;
“may” indicates a permission;
“can” indicates a possibility or a capability.

This document uses italic type to distinguish defined terms from the rest of the text. It is important for the correct understanding of this document that those defined terms are identifiable throughout the text of this document. A list of the terms in italics is given in Annex H.

Annex A contains guidance and rationale for specific clauses and subclauses in this document.

This European Standard was approved by CEN on 26 May 2025.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

European foreword

This document (EN ISO 80369‑6:2025) has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for products with a health purpose including medical devices" in collaboration with Technical Committee CEN-CENELEC/ JTC 3 “Quality management and corresponding general aspects for medical devices” the secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2025, and conflicting national standards shall be withdrawn at the latest by December 2025.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 80369‑6:2016.

Any feedback and questions on this document should be directed to the users’ national standards body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC websites.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United Kingdom.

Endorsement notice

The text of ISO 80369‑6:2025 has been approved by CEN-CENELEC as EN ISO 80369‑6:2025 without any modification.

1 Scope

NOTE Clause A.2 contains guidance or rationale for this clause.

This document specifies requirements for small-bore connectors intended to be used for connections in neural applications.

This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular standards for specific medical devices or accessories.

2 Normative references

3 Terms and definitions

4 Non-interconnectability requirements

5 Materials requirements

6 Dimensions and tolerances

7 Performance requirements

7.1 Positive pressure leakage

7.2 Sub-atmospheric pressure air leakage

7.3 Stress cracking

7.4 Resistance to separation from axial load

7.5 Resistance to separation from unscrewing

7.6 Resistance to overriding

Bibliography

BS EN ISO 80369-6:2025

Small bore connectors for liquids and gases in healthcare applications - Connectors for neural applications

Current

Published:

30 Jun 2025