ISO 10651-5 Lung Ventilators for Medical Use - Test for Gas-Powered Emergency Resuscitators

Medical Device Tests

ISO 10651-5 Lung Ventilators for Medical Use - Test for Gas-Powered Emergency Resuscitators

EUROLAB laboratory provides testing and compliance services within the scope of ISO 10651-5 standard. This standard specifies essential safety and essential performance requirements for gas-powered emergency resuscitators intended for human use by first responders.

ISO 10651-5 Lung Ventilators for Medical Use - Test for Gas-Powered Emergency Resuscitators

This equipment is designed for emergency field use and is intended for continuous operator involvement in normal use.

ISO 10651-5 also specifies requirements for sets of resuscitators.

ISO 10651-5 does not apply to electrically powered resuscitators.

For victims whose lives are at risk due to respiratory failure, particularly during cardiac arrest, resuscitation councils and associations teach that the best end result is achieved if there is a continuous chain of care that begins with cardiopulmonary resuscitation as early as possible and continues until the victim.

In order to improve the care possible in the early stages of this chain, authorities and organizations train non-specialized personnel in key situations, such as when people gather or there is increased risk, so that they can be prepared to provide a higher level of service.

This part of ISO 10651 specifies generally applicable requirements to risks associated with resuscitators and is intended to serve as a tool in the risk management process. The risk management process identifies not only the safety hazards covered in this part of ISO 10651 but also all safety hazards, associated risks and risk control measures.

Conditions or malfunctions that can cause safety hazards are defined in the clauses of this part of ISO 10651 . In these situations, it will often be necessary to conduct a risk management process to determine what the actual safety hazards are and to demonstrate that the identified safety hazards do not arise in the specified situation.

There is a growing understanding that the effectiveness of such intervention can be greatly increased by the use of certain essential equipment, such as those that provide ventilation while avoiding mouth-to-mouth contact. Simple, gas-powered emergency resuscitators can provide controlled ventilation for this purpose, and this document specifies the criteria they must meet.

It is recognized that the manufacturer may not follow all the processes described in this part of ISO 10651 for each component that makes up the resuscitator, such as proprietary components, non-medical subsystems and obsolete parts. In this case, the manufacturer should take special account of the need for additional risk control measures.

EUROLAB assists manufacturers with ISO 10651-5 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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