DIN EN ISO 5366 2017-04 PDF

Full title and description

STB DIN EN ISO 5366:2017-04 — Anaesthetic and respiratory equipment — Tracheostomy tubes and connectors. This document is the German (DIN) adoption of EN ISO 5366 which is identical to ISO 5366:2016 and sets requirements for design, dimensions, materials, connectors and marking of adult and paediatric tracheostomy tubes and associated connectors.

Abstract

Specifies essential performance, construction and testing requirements for tracheostomy tubes and their connectors intended primarily for patients requiring anaesthesia, artificial ventilation or respiratory support. It is applicable to a range of specialised tube types that share common attributes (for example tubes without a machine-end connector, reinforced-wall tubes, tapered tubes, or tubes with suction/monitoring provisions). Hazards associated with flammability (e.g., with electrosurgical units, lasers or flammable anaesthetic agents) are recognised but managed clinically and lie outside the scope; ISO/TR 11991 gives guidance on airway-fire avoidance.

General information

• Status: Published / Current (DIN adoption active; ISO international edition confirmed).
• Publication date: DIN publication/adoption: 01 April 2017 — ISO original edition: October 2016.
• Publisher: Deutsches Institut für Normung (DIN) — adoption of EN ISO 5366 (identical to ISO 5366:2016). ISO is the original international publisher.
• ICS / categories: 11.040.10 — Anaesthetic, respiratory and reanimation equipment.
• Edition / version: EN ISO 5366 (adopted as DIN EN ISO 5366:2017-04); corresponds to ISO 5366:2016, Edition 1 (2016-10).
• Number of pages: ISO 5366:2016 lists 25 pages (international edition); national/adopted publications commonly include national forewords and can appear as ~34–36 pages in distributor listings.

Scope

Covers requirements for adult and paediatric tracheostomy tubes and connectors used with anaesthesia, mechanical ventilation or other respiratory support. Includes specifications for dimensions, materials, cuffs and cuff inflation systems, connectors and marking; it also covers specialised tube variations that share the same essential attributes. Excludes clinical management of airway fires (see ISO/TR 11991 for guidance).

Key topics and requirements

• Definitions and terminology for tracheostomy tubes and connectors.
• Dimensional requirements (diameters, lengths and angles) and designation of sizes for adult and paediatric tubes.
• Material and biocompatibility considerations appropriate for medical use.
• Constructional features: patient and machine ends, cuffs and cuff inflation lines, inner cannula design and optional reinforcement.
• Connector interchangeability and compatibility with breathing systems and ventilators.
• Labelling and marking requirements (identification, size, manufacturer and lot information).
• Performance and safety tests, including dimensional checks, leakage and strength tests, and requirements relevant to intended clinical use.
• Notes on hazards (e.g., flammability) that are outside the standard's prescriptive controls but are highlighted for clinical management.

Typical use and users

Used by medical device manufacturers (design and production of tracheostomy tubes and connectors), test and quality laboratories, conformity assessment bodies, hospital procurement and clinical engineers, regulatory affairs specialists, and standards committees working on airway and respiratory-device interoperability. Clinicians and biomedical engineers consult the standard when selecting or specifying devices to ensure compatibility with ventilation equipment.

Related standards

Closely related documents include ISO 5361 (tracheal tubes and connectors), ISO/TR 11991 (guidance on avoidance of airway fires) and other EN/ISO standards governing connectors and small-bore connectors (for example the ISO 80369 series where applicable to connector safety). National adoptions (BS EN, UNI EN, PN EN, etc.) reproduce the ISO text with national forewords.

Keywords

Tracheostomy tube, tracheostomy connector, anaesthetic equipment, respiratory equipment, airway device, cuff, connector compatibility, ISO 5366, EN ISO 5366, DIN adoption, medical device standard.

FAQ

Q: What is this standard?

A: An international / European standard (adopted by DIN) that specifies requirements for tracheostomy tubes and their connectors; it aligns EN ISO 5366 with ISO 5366:2016 and provides requirements used by manufacturers, testers and purchasers.

Q: What does it cover?

A: Design, dimensions, materials, cuffs and cuff systems, connectors and marking, plus performance and safety tests for adult and paediatric tracheostomy tubes and compatible connectors. It also notes specialised tube types that share common attributes; clinical management of airway fires is outside its prescriptive scope.

Q: Who typically uses it?

A: Medical-device manufacturers, test laboratories, regulatory and quality teams, hospital procurement and biomedical engineers, and standards committees. Clinicians may use it as a technical reference when assessing device compatibility and safety.

Q: Is it current or superseded?

A: The ISO 5366:2016 international edition is published and was confirmed on review; the DIN adoption (DIN EN ISO 5366) was published 01 April 2017 and is listed as the active/current adoption. Users should verify any national amendments or later revisions before applying the standard to new product designs.

Q: Is it part of a series?

A: It is part of the family of standards for anaesthetic and respiratory equipment (ISO/TC 121/SC 2). Related ISO standards include ISO 5361 (tracheal tubes) and companion technical reports such as ISO/TR 11991 on airway-fire avoidance. National and regional EN adoptions reproduce the ISO text as EN ISO 5366.

Q: What are the key keywords?

A: Tracheostomy tube, connector, cuff, dimensions, anaesthetic equipment, respiratory support, ISO 5366, EN ISO, DIN adoption.