Overview
ISO 18193:2021/Amd 1:2025 is an essential international standard issued by the International Organization for Standardization (ISO) focused on cardiovascular implants and artificial organs, specifically addressing cannulae used for extracorporeal circulation. This amendment updates and refines the requirements for sterile, single-use cannulae to enhance patient safety and device performance during various extracorporeal circulation procedures.
Cannulae are critical medical devices designed for the removal and delivery of blood outside the patient’s body during procedures such as cardiopulmonary bypass, extracorporeal lung support, and extracorporeal life support. This standard amendment provides clear technical and safety specifications to meet clinical demands.
Key Topics
The amendment brings significant updates to the scope and technical details of cannulae for extracorporeal circulation:
-
Expanded Scope: Covers cannulae used in a wide range of extracorporeal procedures including:
- Cardiopulmonary bypass (CPB) up to 6 hours
- Extracorporeal lung assist (ECLA) with VV, VAV, AV cannulation
- Left or right heart bypass (LHB, RHB)
- Cardiopulmonary support (CPS)
- Extracorporeal life support (ECLS) with VA cannulation
- Extracorporeal carbon dioxide removal (ECCO2R)
- Other extracorporeal circulation techniques
-
Technical Requirements:
- Specifies negative pressure standard of −6.67 kPa (−50 mmHg) typical for vacuum-assisted venous drainage.
- Introduces testing procedures for dual-lumen cannulae, allowing independent testing of inflow and outflow lumens.
-
Detailed Device Attributes: New requirements for comprehensive product descriptions include:
- Diameters and lengths for multi-stage cannulae
- Positioning and length of side holes
- Connector size and number of Luer ports
- Overall length of cannulae plus connectors
-
Annex Updates: Removal of certain clauses to streamline the documentation and maintain clarity.
Applications
ISO 18193:2021/Amd 1:2025 is valuable for manufacturers, healthcare providers, and regulatory bodies involved in cardiovascular implants and extracorporeal devices:
- Ensures the quality, sterility, and safety of single-use cannulae used during critical extracorporeal circulation procedures.
- Helps in reducing device-associated risks such as blood trauma, infection, or malfunction.
- Supports compliance with international clinical safety standards essential for cardiovascular surgeries and life support systems.
- Facilitates manufacturers in designing cannulae that meet rigorous performance and labeling criteria, improving device traceability and usability.
- Enhances patient outcomes by standardizing device characteristics and testing protocols across diversified extracorporeal circulation techniques.
Related Standards
ISO 18193:2021/Amd 1:2025 aligns with other standards in cardiovascular implants and medical devices, including but not limited to:
- ISO 10993 series - Biological evaluation of medical devices ensuring biocompatibility of cannula materials.
- ISO 13485 - Quality management systems for medical device manufacturing.
- ISO 14708 series - Implants for surgery standards covering cardiovascular implantable devices.
- ISO/IEC Directives - Guidelines for the preparation, approval, and publication of international standards.
By integrating with these standards, ISO 18193 supports improved global harmonization and regulatory acceptance for cardiovascular extracorporeal devices.
Compliance with ISO 18193:2021/Amd 1:2025 is crucial for stakeholders involved in the development, manufacturing, provisioning, and clinical use of cannulae for extracorporeal circulation. This amendment ensures continued advancement in safety and performance, reflecting the latest clinical practices and technological improvements in cardiovascular implants and artificial organs. For full details and implementation guidance, refer to the official ISO documentation and your national standards body.
Open preview (PDF)Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation — Amendment 1