EN ISO 5356-2:2012

Overview

EN ISO 5356-2:2012 is an internationally recognized standard developed by ISO and adopted by CEN, focusing on anaesthetic and respiratory equipment-specifically, screw-threaded weight-bearing conical connectors. These connectors are critical components designed for use with inhalation anaesthesia apparatus and ventilators to securely mount heavy or fragile accessories within breathing systems. By specifying precise dimensional requirements, this standard ensures reliability, safety, and compatibility in medical gas delivery systems.

This part of the ISO 5356 series complements Part 1, which covers lightweight cone and socket connectors, by addressing the need for robust and secure connections that support heavier equipment. EN ISO 5356-2:2012 applies to two main connector types: 22 mm male/female connectors and 22/15 mm coaxial connectors.

Key Topics

• Scope and Purpose Specifies dimensional requirements for screw-threaded conical connectors supporting weight-bearing applications in respiratory and anaesthesia equipment.

• Connector Types Covered

  • 22 mm screw-threaded weight-bearing connectors
  • 22 mm/15 mm coaxial screw-threaded connectors

• Design and Dimensions Detailed specifications include:

  • Thread dimensions (M33 × 2, 6g for male; M33 × 2, 6H for female, per ISO 965-2)
  • Maximum free axial movement of union nut not exceeding 2 mm to ensure secure disconnection without partial engagement
  • O-ring groove dimensions for sealing integrity
  • Component features such as knurling, retaining lugs, shoulders or circlips for secure assembly

• Compatibility and Safety Designed for compatibility with Part 1 connectors, these screw-threaded connectors aid in minimizing misconnections. The standard emphasizes ease of use, sterilization, and hand operation while ensuring the secure joining of heavy accessories.

• Exclusions The standard does not specify application requirements for these connectors, which are covered by other relevant medical device standards.

Applications

• Anaesthesia and Respiratory Equipment Used within breathing systems for connecting ventilators, anaesthesia machines, and related breathing attachments that require robust mechanical support for heavy components.

• Medical Gas Delivery Systems Ensures reliable connections at the common gas outlet or within breathing circuits where weight-bearing stability is critical.

• Hospital and Surgical Settings Supports secure assembly of devices during surgical procedures where safety and equipment integrity are paramount.

• Device Manufacturing and Testing Provides manufacturers with precise engineering requirements to maintain interoperability and quality assurance in medical respiratory connectors.

Related Standards

• EN ISO 5356-1: Anaesthetic and Respiratory Equipment – Conical Connectors – Part 1: Cones and Sockets Defines requirements for lightweight, non-weight-bearing connectors, ensuring overall system compatibility.

• ISO 965-2: General Purpose Metric Screw Threads – Tolerances Specifies thread size and tolerance limits essential for designing the screw-threaded components in this standard.

• ISO 4135: Anaesthetic and Respiratory Equipment – Vocabulary Provides standardized definitions supporting clear communication and implementation.

• Other Medical Device Standards Application-specific requirements for connectors are addressed in standards related to ventilators, anaesthetic machines, and breathing attachments to ensure safety and performance within device ecosystems.

Implementing EN ISO 5356-2:2012 helps manufacturers and healthcare providers maintain high safety standards, improve device reliability, and reduce risks related to misconnection or equipment failure in respiratory and anaesthesia care. This standard plays a crucial role in supporting life-critical medical procedures by defining clear, tested requirements for weight-bearing anaesthetic connectors.