TS EN ISO 10079-2 Medical Aspiration Equipment - Part 2: Manually Operated Aspiration Equipment

TS EN ISO 10079-2 Medical Aspiration Equipment - Part 2: Manually Operated Aspiration Equipment

In the ISO 10079-2 standard developed by the International Standards Organization (ISO), the characteristics and test methods of hand-operated aspirators (suction equipment) are described. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 10079-2 Medical aspiration equipment - Part 2: Manually operated aspiration equipment.

TS EN ISO 10079-2 Medical Aspiration Equipment - Part 2: Manually Operated Aspiration Equipment

This standard describes the safety and performance requirements for suction and manually operated medical suction equipment called oro-pharyngeal (golden pharynx). It includes suction equipment that works with the foot or the hand, or both.

The diagram in the annex to the ISO 10079 standard shows three parts of the standard for typical systems. This standard consists of the following sections under the general heading of medical suction equipment:

  • Part 1: Electrically powered suction equipment
  • Part 2: Manually operated suction equipment
  • Part 3: Suction equipment fed from vacuum or positive pressure gas source

The ISO 10079-2 standard contains additional requirements for aspiration equipment for field use or transport use.

The most common use of hand-operated aspiration is in situations outside of healthcare facilities, commonly described as field use or transport use. In these cases, use includes extreme weather or terrain conditions. Additional requirements for spiration equipment designed for land or transport use are contained in this standard.

The ISO 10079-2 standard does not apply to:

  • End pieces such as suction catheters and suction tips
  • Dental suction equipment
  • Mucus extractors, including neonatal mucus extractors

Several standards with normative reference in the implementation of this standard are: ISO 5356-1, ISO 70001, ISO 14155, ISO 14971, ISO 15223-1, ISO 80369, IEC 62366 and EN 1041.

Our organization also provides ISO 10079-2 manual aspirator (suction equipment) testing services to businesses as part of our laboratory services .

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