TS EN ISO 10651-4 Lung Ventilators for Medical Use - Part 4: Specific Features for Operator Operated Resuscitators

TS EN ISO 10651-4 Lung Ventilators for Medical Use - Part 4: Specific Features for Operator Operated Resuscitators

In the ISO 10651-4 standard developed by the International Standards Organization (ISO), the performance characteristics and test methods of heart massage devices (resuscitators) used for medical needs and operated by operators are described. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 10651-4 Lung ventilators for medical use - Part 4: Certain features for resuscitators operated by the operator.

TS EN ISO 10651-4 Lung Ventilators for Medical Use - Part 4: Specific Features for Operator Operated Resuscitators

This standard describes the requirements for portable operator-operated resuscitators, which are designed for use in all age groups and are intended to provide lung ventilation to people with insufficient breathing. Operator-operated resuscitators for infants and children are determined according to body mass range and approximate age equivalent. This standard does not cover electrical and gas powered resuscitators.

A resuscitator is a device that uses positive pressure to keep the lungs of an unconscious person who cannot breathe oxygenated and alive. There are essentially three types of resuscitators:

  • Manual resuscitator (bag valve mask) with supplemental oxygen from a hand-squeezed plastic bulb or a high pressure tank using a mask and ambient air
  • Expired air or breathing resuscitator
  • Oxygen powered resuscitator

Among these, the most popular gas-operated resuscitator type time-cycle respirators. All resuscitation devices should be capable of delivering over 85 percent oxygen when a gas source is available.

The standards that are referred to as normative in the application of this standard and indispensable for its implementation are: EN 148-1, EN 556, EN 737-1, EN 868-1, EN 1041, EN 1281-1, EN 13544-2 and EN ISO 4135.

Our organization also provides performance testing services for cardiopulmonary resuscitation (CPR) devices used for medical needs and operated by technicians, within the scope of laboratory services, to businesses, in accordance with ISO 10651-4 .

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