Overview
SIST EN ISO 5356-2:2013/A1:2019 specifies the dimensional requirements for screw-threaded, weight-bearing conical connectors designed for use with anaesthetic and respiratory equipment. This amendment aligns with ISO 5356-2:2012/Amd 1:2019 and addresses connectors capable of supporting the mounting of heavy or fragile medical accessories on inhalation anaesthesia apparatus and ventilators. The standard focuses on 22 mm connectors and 22 mm/15 mm coaxial connectors, ensuring robust and standardized connections across international healthcare environments.
Key Topics
- Dimensional Specifications: Outlines precise geometry for 22 mm and combined 22 mm/15 mm coaxial screw-threaded conical connectors to ensure reliable mechanical strength and compatibility.
- Weight-Bearing Capability: Ensures connectors can safely support heavy accessories attached to anaesthesia and ventilation devices, such as humidifiers, filters, or breathing circuits.
- Interoperability: Specifies that these connectors are compatible with cones and sockets defined in ISO 5356-1, minimizing the risk of misconnections and enhancing patient safety.
- Testing Requirements: Includes compliance verification through measurement and functional testing of connectors before use, supporting the safety and reliability of medical equipment.
- Scope Clarification: This amendment strictly defines connector dimensions but refers users to other specific standards for the practical application and integration with medical devices.
Applications
The standard is vital in settings using:
- Inhalation Anaesthesia Apparatus: Provides a secure and standardized means to connect and mount weighty or sensitive components required for patient ventilation or gas delivery.
- Mechanical Ventilators: Ensures stable attachment of external breathing circuits, filters, or humidification units, especially in intensive care or surgical environments.
- Hospitals and Clinical Facilities: Facilitates safe, error-reducing assembly and maintenance of anaesthetic and respiratory devices by healthcare professionals, supporting infection control and patient safety.
- Medical Device Manufacturing: Guides the design and production of connectors and accessories, helping manufacturers demonstrate conformity with international requirements and facilitate device acceptance in multiple global markets.
Related Standards
To ensure proper integration and compatibility of anaesthetic and respiratory connectors, the following related standards should be considered:
- ISO 5356-1:2015, Anaesthetic and Respiratory Equipment – Conical Connectors – Part 1: Covers cones and sockets for lightweight respiratory attachments. Connectors specified in Part 2 must align with these fundamental requirements for seamless interoperability.
- ISO/TC 121 and CEN/TC 215 Standards: Additional ISO and CEN technical specifications provide guidance for the application of these connectors in particular types of medical equipment and their accessories.
- EN ISO 5356-2:2012: The original base document to which this amendment applies, providing broader context for conical connector usage in Europe.
By specifying internationally recognized dimensions and compatibility checks, SIST EN ISO 5356-2:2013/A1:2019 supports standardized, safe connections for anaesthetic and respiratory equipment, benefiting both healthcare providers and medical device manufacturers worldwide.
