BS EN ISO 5356-2:2012+A1:2019

Overview

BS EN ISO 5356-2:2012+A1:2019 specifies the requirements for conical connectors used in anaesthetic and respiratory equipment. These connectors are designed to be screw-threaded and weight-bearing, ensuring secure and reliable connections in medical applications. The standard is crucial for manufacturers, healthcare professionals, and compliance officers involved in the design, production, and use of medical equipment.

Key Requirements

• Connector Design: The standard outlines the dimensional and performance requirements for conical connectors, ensuring compatibility across various devices.
• Material Specifications: It specifies the materials suitable for manufacturing connectors, focusing on durability and resistance to sterilisation processes.
• Testing Procedures: Detailed testing methods are provided to assess the performance and safety of the connectors under various conditions.
• Marking and Labelling: Requirements for appropriate marking and labelling of connectors to ensure traceability and compliance with safety standards.

Implementation Benefits

Adhering to BS EN ISO 5356-2:2012+A1:2019 offers several practical benefits for healthcare technology manufacturers and users:

• Enhanced Safety: By following the standard, manufacturers can ensure that their connectors meet rigorous safety criteria, reducing the risk of equipment failure during critical procedures.
• Interoperability: The standard promotes compatibility between different devices and systems, facilitating seamless integration in clinical settings.
• Quality Assurance: Compliance with the standard serves as a benchmark for quality, helping manufacturers to maintain high production standards and reduce liability risks.
• Market Access: Meeting the requirements of this standard can enhance a manufacturer's reputation and facilitate access to international markets.

Compliance Value

Compliance with BS EN ISO 5356-2:2012+A1:2019 is essential for organisations involved in the healthcare sector. It not only ensures that products are safe and effective but also aligns with regulatory requirements set forth by health authorities. Non-compliance can lead to significant legal and financial repercussions, including product recalls and damage to reputation.

Healthcare providers are increasingly required to demonstrate compliance with recognised standards as part of their accreditation processes. By implementing the guidelines of this standard, organisations can enhance their compliance posture and ensure that they are providing the highest level of care to patients.

In summary, BS EN ISO 5356-2:2012+A1:2019 is a vital standard that underpins the safety and efficacy of anaesthetic and respiratory equipment. Its comprehensive requirements and guidelines provide a framework for manufacturers and healthcare professionals to ensure the reliability of conical connectors in critical medical applications.