What is ISO 10079-4 about?
ISO 10079-4 specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients, and field and transports use.
Suction equipment intended to be dismantled by the user (e.g., for cleaning) shall be designed to facilitate correct assembly or marked to indicate correct reassembly and shall meet the requirements of Clause 7, as appropriate, after dismantling and reassembly in accordance with the manufacturer’s instructions.
NOTE: ISO 10079-4 is not applicable to, end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips, syringes, dental suction equipment, anesthetic gas scavenging systems, laboratory suction, autotransfusion systems, mucus extractors including neonatal mucus extractors, suction equipment where the collection container is downstream of the vacuum pump, ventouse (obstetric) equipment, suction equipment marked for endoscopic use only, and plume evacuation systems.
Who is ISO 10079-4 for?
ISO 10079-4 is applicable to-
- Hospitals
- Domiciliary care of patients
- Manufacturers of medical suction equipment
Why should you use ISO 10079-4?
ISO 10079-4 provides design, cleaning, and sterilization requirements for medical suction equipment that are common to all parts of the ISO 10079 series. Because of which prevention of transmission of infectious substances will be achieved.
Manufacturers can use type tests different from those detailed within ISO 10079-4 if an equivalent degree of safety is obtained.