Skip to main content
Back

EVS-EN ISO 5361:2023

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023, Corrected version 2023-11)

General information

Valid from 15.02.2023
Base Documents
ISO 5361:2023; EN ISO 5361:2023
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.02.2023
Main
01.11.2016
Main
This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications.
Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.
NOTE 1      There is guidance or rationale for this clause contained in Annex A.2.
NOTE 2      ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.

Required fields are indicated with *

*
*
*
PDF
31.72 € incl tax
Paper
31.72 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main + amendment

EVS-EN ISO 11607-1:2020+A11+A1:2023

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + ISO 11607-1:2019/Amd 1:2023)
Newest version Valid from 15.11.2023
Main + amendment

EVS-EN ISO 11607-2:2020+A11+A1:2023

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019 + ISO 11607-2:2019/Amd 1:2023)
Newest version Valid from 15.11.2023
Main

EVS-EN ISO 10993-17:2023

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
Newest version Valid from 01.12.2023
Main

EVS-EN ISO 10993-10:2023

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
Newest version Valid from 01.03.2023