BS EN ISO 5361:2023 PDF

Scope: 1 Scope 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.

BS EN ISO 5361:2023 Referenced Document

ISO 14971 Medical devices - Application of risk management to medical devices
ISO 18190:2016 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
ISO 4135 Anaesthesiology — Vocabulary
ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

2023 BS EN ISO 5361:2023 Anaesthetic and respiratory equipment. Tracheal tubes and connectors
2016 BS EN ISO 5361:2016 Anaesthetic and respiratory equipment. Tracheal tubes and connectors
2012 BS EN ISO 5361:2012 Anaesthetic and respiratory equipment. Tracheal tubes and connectors