Overview
ISO 18241:2016/Amd 1:2019 is an important amendment to the international standard for cardiovascular implants and extracorporeal systems, specifically addressing cardiopulmonary bypass systems and venous bubble traps. Released by the International Organization for Standardization (ISO), this amendment focuses on connectors used in these medical devices, ensuring secure and standardized connections between blood pathway components.
The amendment guides manufacturers, healthcare providers, and regulatory bodies on connector specifications, testing, and compatibility. It incorporates references to ISO 80369-7, which standardizes small-bore connectors for healthcare applications, thus enhancing patient safety by minimizing misconnections in cardiovascular procedures.
Key Topics
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Connector Standards and Compatibility
Connectors for venous bubble traps must ensure secure connections per testing procedures defined in the amendment. Accepted connector types include those compliant with ISO 8637-1:2017 and ISO 80369-7. The amendment also endorses connector dimensions formerly outlined by ISO 594-1 and ISO 594-2.
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Performance Testing Requirements
Connector performance must be validated according to ISO 80369-7, Clause 6, using reference fittings specified in Annex A. These tests verify mechanical strength, secure locking, and resistance to accidental disconnection.
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Luer and Luer Lock Fittings
Detailed in Annex A, the amendment illustrates and specifies dimensions for 6% (Luer) conical slip fittings and Luer lock fittings. These connectors are widely used to connect tubing in cardiopulmonary bypass systems, ensuring leak-proof and secure joints.
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Gauging and Reference Fittings
Standardized steel gauges and reference fittings described in the annex help manufacturers maintain product conformity during quality control and certification processes. These tools ensure fittings meet dimensional and mechanical requirements to prevent clinical failures.
Applications
ISO 18241:2016/Amd 1:2019 serves critical applications in the medical device industry including:
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Cardiopulmonary Bypass Systems
Ensuring reliable venous bubble trap connections enhances patient safety during heart surgeries by preventing air embolism.
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Extracorporeal Circulation Devices
Connectors that comply with this amendment support safe blood flow management outside the body, including during dialysis and cardiac support.
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Medical Device Design and Manufacturing
Manufacturers use the amendment to design connectors with consistent dimensions and performance characteristics facilitating global regulatory acceptance.
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Clinical Risk Management
Standardized connectors reduce risks of misconnections and compatibility errors, contributing to better outcomes and compliance with healthcare safety protocols.
Related Standards
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ISO 80369-7:2016
Specifies small-bore connectors for intravascular or hypodermic applications, referenced by ISO 18241 Amendment 1 to harmonize connector safety.
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ISO 8637-1:2017
Pertains to extracorporeal blood purification devices with related connector specifications that complement cardiopulmonary bypass system requirements.
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ISO 594-1 & ISO 594-2 (Superseded)
Former standards for conical fittings referenced for dimensional legacy compatibility within Annex A.
Summary
ISO 18241:2016/Amd 1:2019 standardizes connectors for venous bubble traps in cardiopulmonary bypass systems, ensuring secure, reliable, and safe blood pathway connections. By aligning with ISO 80369-7 and providing detailed dimensional guidelines, it supports the manufacture and use of connectors that minimize clinical risks and improve device interoperability. This amendment plays a pivotal role in advancing cardiovascular implant safety and effective extracorporeal circulation management worldwide.
Open preview (PDF)Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps — Amendment 1: Connectors
