TS EN ISO 10079-1 Medical Aspiration Equipment - Part 1: Electrically Operated Aspiration Equipment

The ISO 10079-1 standard, developed by the International Organization for Standardization (ISO), describes the basic safety and performance characteristics and test methods of electrically operated medical aspiration devices. This standard has also been published in Turkey by the Turkish Standards Institute (TSE) under the title: TS EN ISO 10079-1 Medical aspiration equipment - Part 1: Electrically operated aspiration equipment.

This standard describes safety and performance requirements for electrically powered medical and surgical suction equipment. This standard applies to equipment used in care and treatment in hospitals and health institutions and homes.

However, the ISO 10079-1 standard does not cover the following equipment:

• Central power supply such as vacuum or compressed air, piping systems of vehicles and buildings, and wall fasteners
• End pieces such as suction catheters, drains, curettes, suckers and suction tips
• syringes
• Dental suction equipment
• Anesthetic gas cleaning systems
• Laboratory aspirators
• Autotransfusion systems
• Mucus extractors, including neonatal mucus extractors
• Suction equipment where the collection container is downstream of the vacuum pump
• Suction cup equipment used at birth
• Suction equipment marked for endoscopic use only

This part of the ISO 10079-1 standard is followed by the following two standards:

• Part 2: Manually operated suction equipment
• Part 3: Suction equipment fed from vacuum or positive pressure gas source

Standards that are referred to as normative in the application of this standard and indispensable for its implementation are: ISO 3744, ISO 5356-1, ISO 7000, ISO 14155, ISO 14971, ISO 15223-1, ISO 80369 (all parts), IEC 60529, IEC 60601-1 , IEC 60601-1-6, IEC 60601-1-11, IEC 60601-1-12: 2014, IEC / TR 60878, IEC 61672-1, IEC 62366 and EN 1041.

Within the scope of laboratory services, our organization also provides basic safety and performance testing services of ISO 10079-1 electrically powered medical aspiration device.