EN ISO 10079-1 Medical Suction Equipment, Part 1: Standard Test for Electrically Operated Suction Equipment

Medical Device Tests

EN ISO 10079-1 Medical Suction Equipment, Part 1: Standard Test for Electrically Operated Suction Equipment

EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 10079-1 standard. This part of EN ISO 10079 specifies minimum safety and performance requirements for medical and surgical aspiration equipment for healthcare facilities such as hospitals, home care of patients, and field and transportation use.

EN ISO 10079-1 Medical Suction Equipment, Part 1: Standard Test for Electrically Operated Suction Equipment

While such equipment can be operated by centrally powered tubular vacuum systems, compressed gases and electricity, or can be manually operated for a variety of applications, this part of EN 10079 is only for mains and battery powered aspiration equipment.

This part of EN ISO 10079 does not apply to:

  • Central power supply (with vacuum/compressed air generation), piping systems and wall connectors of vehicles and buildings;
  • Catheter tubes, drains, curettes and aspiration tips;
  • syringes;
  • dental aspiration equipment;
  • Waste gas cleaning systems;
  • laboratory aspiration;
  • Autotransfusion systems;
  • passive urinary drainage;
  • closed systems for wound drainage;
  • Gravity gastric drainage;
  • Orally operated mucus extractors;
  • Aspiration equipment where the collection vessel is downstream of the vacuum pump;
  • Equipment marked as aspiration unit for permanent tracheostomy;
  • Ventouse (birth) equipment;
  • neonatal mucus extractors;
  • Aspiration equipment marked for endoscopic use only.

Electrically powered aspiration equipment is associated with its intended applications in the event of normal and single failure, which is not reduced to an acceptable level using risk management procedures in accordance with ISO 14971 when transported, stored, installed, operated in normal use and maintained according to the manufacturer's instructions.

EUROLAB assists manufacturers with EN ISO 10079-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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