SIS-EN-ISO-10079-1 › Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)
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This part of ISO 10079 specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field and transport use.This part of ISO 10079 does not apply to the following:a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors;b) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;c) syringes;d) dental suction equipment;e) anaesthetic gas scavenging systems;f) laboratory suction;g) autotransfusion systems;h) mucus extractors including neonatal mucus extractors;i) suction equipment where the collection container is downstream of the vacuum pump;j) ventouse (obstetric) equipment;k) suction equipment marked for endoscopic use only;l) plume evacuation systems.
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Medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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SS-EN ISO 10079-1:2015
Dec. 1, 2015
EN ISO 10079-1:2015(IDT); ISO 10079-1:2015(IDT)