SIST EN ISO 80369-6:2025

Name: SIST EN ISO 80369-6:2025 — Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO 80369-6:2025)
SKU: SIST EN ISO 80369-6:2025
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Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO 80369-6:2025)

Название (английский):

Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO 80369-6:2025)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 40
Дата публикации:: 25 сентября 2025 г.
Издание:: ISO 80369-6:2025
ICS:: 11.040.25

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Язык документа:

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Срок поставки:7 раб. дн. (перевод)

Цена:72 000 ₽

Описание (английский):

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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 80369-6:2025 (ISO 80369-6:2025) defines requirements for small-bore connectors for neural applications used in healthcare. The standard covers design, materials, dimensional tolerances and performance requirements for connectors intended for connections in neural sites (spine, intrathecal/subarachnoid space, brain ventricles, epidural/epidural spaces). It applies to the connector interfaces themselves and does not define requirements for the medical devices or accessories that use these connectors.

Key topics and technical requirements

Non‑interconnectability: Connectors are designed to reduce misconnections with other medical fluid/gas systems (see ISO 80369-1 for overarching requirements).

Materials requirements: Specifies acceptable materials and references applicable mechanical property standards (updated to include parts of the ISO 527 series).

Dimensions and tolerances: Normative dimensional specifications and tolerances are given (Annex B) along with reference connector designs for testing (Annex C).

Performance requirements: Includes tests and pass/fail criteria for:

Positive pressure leakage (pressure decay and falling-drop methods - Annex F)
Sub‑atmospheric pressure air leakage (Annex G)
Stress cracking resistance
Resistance to separation under axial loads and unscrewing
Resistance to overriding (mechanical integrity and secure connection)

Test methods and annexes: Normative test methods and reference connectors are provided (Annexes B, C, F, G). Informative Annex A provides rationale/guidance; Annex D offers assessment guidance for devices with these connections; Annex E references IMDRF essential principles.

Practical applications and who uses it

Medical device manufacturers designing neural catheters, infusion sets, cerebrospinal fluid drains, intrathecal ports and anesthesia delivery systems use this standard to:

Ensure connector compatibility, safety and regulatory readiness
Define product specifications and testing protocols

Regulatory bodies, testing laboratories and notified bodies use EN ISO 80369-6:2025 to assess connector conformity and to verify performance claims.

Hospital procurement, clinicians and biomedical engineers can use the standard to understand connector safety attributes and reduce misconnections in neural procedures.

SIST EN ISO 80369-6:2025

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and who uses it

Related standards

Технические детали

ISO 80369-6:2025

Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neural applic…

ISO 80369-20:2024

Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

ISO 80369-1:2010

Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements

SIST EN ISO 527-2:2025

Plastics - Determination of tensile properties - Part 2: Test conditions for moulding and extrusion plastics…