ISO 8382 Standard Test Method for Resuscitators Intended for Human Use

Medical Device Tests

ISO 8382 Standard Test Method for Resuscitators Intended for Human Use

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 8382 testing. Specifies minimum performance and safety requirements for small, portable, operator-operated and gas-operated ventilator resuscitators for use in an emergency.

ISO 8382 Standard Test Method for Resuscitators Intended for Human Use

Electrically powered devices and similar devices intended to assist or provide long-term ventilation of a patient are not covered by this standard. Definitions of terms are given. Appendices include test methods, physical parameters, and a statement of justification.

Devices designed to supply gas only to normally breathing patients and devices designed for prolonged ventilation of patients are not covered by this International standard.

This International standard applies to respiratory resuscitators, ie small portable ventilators intended for emergency use both inside and outside hospitals. These devices are intended for emergency use by medical personnel1 and personnel with very limited training. It is designed for use in an emergency and during patient transport.

The effective and safe use of a resuscitator is determined not only by the Performance of the resuscitator, but also by the skill of the Operator. The Chis International standard does not describe the content of Training Programs to develop this type of skill and does not specify who should or should not use the resuscitator.

The instructions provided should include a warning that the unit should only be used by a person who has received appropriate training in resuscitation techniques.

EUROLAB assists manufacturers with ISO 8382 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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