EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 10079-2 testing. This part of ISO 10079 specifies safety and performance requirements for manually operated aspiration equipment designed for oropharyngeal aspiration. Applies to foot or hand operated equipment or both.
The most common use of manual aspiration is in situations outside of healthcare settings, often defined as field use or transportation use. Use in these situations may include extreme weather or terrain conditions. Additional requirements for suction equipment intended for use in the field or in transport are contained in this part of ISO 10079.
This part of ISO 10079 does not apply to:
This part of ISO 10079 specifies generally applicable requirements to risks associated with manually operated suction equipment. A risk management process will be applied to the design of the device.
When hand-operated suction equipment is transported, stored, installed, operated in normal use and maintained according to the manufacturer's instructions, it shall carry no risks that are not reduced to an acceptable level using risk management procedures in accordance with ISO 14971.
Where the requirements of this part of ISO 10079 refer to independence from unacceptable risk, the acceptability or unacceptability of that risk should be determined by the manufacturer in accordance with the acceptable risk determination policies.
EUROLAB assists manufacturers with EN ISO 10079-2 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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