Overview
SIST EN ISO 16571:2024/A1:2026 is an important amendment to the international standard ISO 16571:2024, concerning systems for evacuation of plume generated by medical devices. Medical plumes, such as surgical smoke produced during procedures using electrosurgical or laser devices, can pose significant health risks to patients and healthcare personnel. This amendment provides updated requirements and enhanced guidance for system components, terminology, safety, and testing, ensuring better safety, performance, and environmental control in medical settings.
This amendment is published by SIST, the Slovenian Institute for Standardization, in alignment with the ISO Technical Committee 121/Subcommittee 6 (ISO/TC 121/SC 6), focusing on anaesthetic, respiratory, and reanimation equipment.
Key Topics
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Terminology Updates:
The amendment clarifies and updates critical definitions:
- Active Plume Evacuation Systems (PES): Systems designed for plume evacuation via endoscopic/laparoscopic ports using an external vacuum source.
- Capture Devices: Accessories placed to capture plume at the point of generation, available in single-use or reusable forms.
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System Design and Performance:
- Requirements on the use of venturi devices prohibit their operation with medical gases when generating airflows exceeding 20 liters/min, mitigating risk to pipeline systems.
- Details regarding the necessary particulate filtration capability, mandating at least ULPA filter ISO 55 U efficiency, as outlined in ISO 29463-1:2024.
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Testing and Compliance:
- Procedures for noise measurement, accounting for the flow generator and filtration subsystem.
- Guidelines for testing PES components when integrated within larger systems; only the PES is subject to direct evaluation.
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Operational Guidance:
- Active PESs may be powered by various vacuum sources, including stationary, portable, or pipeline sources, and must comply with specific requirements regarding safety and noise control.
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Health and Safety Considerations:
- Particle concentration limits in plume removal based on research findings, confirming that maximum concentrations support effective reduction strategies without setting unrealistic absolute thresholds.
Applications
Proper plume evacuation systems are essential for a wide range of medical procedures where devices generate smoke or aerosols. Key application areas include:
- Operating Rooms: Ensures that hazardous aerosols and particles generated by electrosurgery, laser surgery, or cautery are effectively captured and filtered.
- Endoscopic and Laparoscopic Procedures: Specialized requirements for plume evacuation through minimally invasive surgery ports.
- Hybrid Operating Environments: Integrated systems in advanced surgical suites where safety, air quality, and compliance with infection control guidelines are critical.
- Equipment Manufacturing: Provides manufacturers with updated technical specifications for design, testing, and labeling of new or existing plume evacuation systems.
These updated requirements help hospitals, clinics, and device manufacturers ensure compliance, safeguard occupational health, and enhance the quality and effectiveness of plume management in clinical practice.
Related Standards
For further guidance and complementary requirements, refer to:
- ISO 16571:2024 - Original standard for systems for evacuation of plume generated by medical devices
- ISO 29463-1:2024 - High-efficiency filtration (ULPA filter requirements)
- ISO 4135 - Definition and requirements for medical gases
- EN ISO 16571:2024 - European adoption of the standard
- ICS 11.040.10 - Classification under anaesthetic, respiratory, and reanimation equipment
These standards collectively support a robust framework for the specification, testing, and maintenance of medical plume evacuation systems, addressing both safety and operational performance.
By applying SIST EN ISO 16571:2024/A1:2026, stakeholders contribute to safer surgical environments, improved healthcare outcomes, and regulatory compliance in the use of medical devices that generate plumes.