EN ISO 16571:2024/FprA1

Overview

EN ISO 16571:2024/FprA1 is an amendment to the international standard that addresses the safety and performance of systems for the evacuation of plume generated by medical devices. Managed by CEN and developed under the ISO technical committee for anaesthetic, respiratory and reanimation equipment (ICS 11.040.10), this amendment refines and expands the existing requirements. Proper evacuation of surgical smoke and plume is critical for infection control, occupational safety, and air quality in medical environments such as operating rooms and procedure suites.

Key Topics

This amendment introduces and clarifies several essential areas related to plume evacuation systems:

• Definitions and Terms

  • Active Plume Evacuation Systems (PES): Systems that evacuate plume via endoscopic or laparoscopic ports using an external vacuum source.
  • Capture Devices: Accessories that collect plume at the generation site for transfer to the evacuation subsystem. They may be single-use or reusable.

• Performance Requirements

  • Vacuum Source Limitations: When venturi systems are used to generate airflow above 20 liters per minute, they may not be driven by medical gas lines per ISO 4135, minimizing risks to hospital pipeline infrastructure.
  • Filtration Efficiency: Minimum filtration standards require the use of an ultra-low penetration air (ULPA) filter meeting ISO 29463-1:2024, achieving ISO 55 U efficiency. Pre-filters and adsorbers may be included as needed.
  • Noise Measurement: Sound levels produced by the plume evacuation and filtration system must be tested, ensuring compliance with acceptable noise standards.
  • Integration Clause: For plume evacuation systems integrated into other medical equipment, only the evacuation subsystem must meet these requirements.

• Design and Usage Guidance

  • System Power Options: Active PES units may run on self-power, mobile, portable, stationary, or pipeline vacuum sources, provided performance and safety clauses are met.
  • Plume Concentration Standards: Research supports a maximum concentration of 10^5 particles/cm³ as a reasonable limit for monopolar electrosurgery tools, with an appropriate tolerance band for measurement.

Applications

Plume evacuation systems standardized under EN ISO 16571:2024/FprA1 are vital in healthcare settings using energy-based surgical devices:

• Operating Rooms: Surgical smoke generated by electrosurgical, laser, or ultrasonic tools is efficiently captured and filtered, protecting staff and patient health.
• Endoscopic and Laparoscopic Procedures: Guidance on minimum airflow and equipment integration enables effective removal of airborne hazards during minimally invasive procedures.
• Dental and Outpatient Surgeries: Adapted evacuation solutions reduce exposure to potentially harmful surgical plumes in smaller practice settings.
• Medical Equipment Manufacturing: Device makers use these enhanced requirements to design compliant products, ensuring robust plume management and ease of regulatory approval.
• Hospital Facility Management: Adoption of compliant systems supports facility-wide infection prevention, occupational exposure limits, and maintenance of air quality.

Related Standards

For comprehensive implementation, consider these connected standards and guidelines:

• ISO 16571:2024: The original base standard for plume evacuation systems generated by medical devices.
• ISO 4135: Specifies definitions and requirements for medical gas pipeline systems.
• ISO 29463-1:2024: Outlines testing and classification for high-efficiency air filters, including ULPA filtration.
• National and Regional Regulations: Local healthcare regulations may reference or require compliance with EN ISO 16571 and its amendments.
• Other ISO/IEC 11.040.10 Standards: Cover a range of anaesthetic, respiratory, and reanimation medical equipment, ensuring integration with wider hospital engineering systems.

EN ISO 16571:2024/FprA1 assures healthcare providers and device manufacturers that their plume evacuation practices align with the latest safety, performance, and filtration benchmarks in medical device operations.