DANSK DS/EN ISO 10079-3 PDF

This part of ISO 10079 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source (see Figure 1). In particular it applies to equipment connected to pipelines and Venturi attachments The equipment may be stand alone or part of an integrated system. Suction equipment with components controlled by electrical means, e.g. electronic timing, may also need to comply with IEC 60601-1. This part of ISO 10079 does not apply to electrically powered suction equipment, whether mains electricity or battery-powered, which is dealt with in ISO 10079-1, nor to manually powered suction equipment which is dealt with in ISO 10079-2, nor to the following: a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors; b) catheter tubes, drains, curettes and suction tips; c) syringes; d) dental suction equipment; e) waste gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) passive urinary drainage; i) closed systems for wound drainage; j) gravity gastric drainage; k) orally operated mucous extractors; l) suction equipment where the collection container is downstream of the vacuum pump; m) equipment marked as suction unit for permanent tracheostomy; n) ventouse (obstetric) equipment; o) neonatal mucous extractors; p) breast pumps; q) liposuction; r) uterine aspiration. Key 1 Vacuum indicator 2 Filter 3 Collection container 4 Vacuum regulator NOTE 1 – ISO 10079-1 applies to mains electricity and battery-powered suction equipment. ISO 10079-2 applies to manually powered suction equipment. ISO 10079-3 applies to suction equipment powered from a vacuum or pressure source. NOTE 2 – Suction equipment shown are typical examples, and actual systems may consist of other arrangements and components.