SIS-EN-ISO-10079-2 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)

SIS-EN-ISO-10079-2 - EDITION 4 - CURRENT
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This part of ISO 10079 specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems.The commonest use of manually powered suction is in situations outside of health care settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. Additional requirements for suction equipment intended for field and/or transport use are included in this part of ISO 10079.This part of ISO 10079 does not apply to the following:a) end pieces such as suction catheters, Yankauer sucker and suction tips;b) dental suction equipment;c) mucus extractors, including neonatal mucus extractors.

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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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Designation Name

SS-EN ISO 10079-2:2014

Revision Level

EDITION 4

Status

Current

Publication Date

May 12, 2014

Language(s)

English

Page Count

36

International Equivalent

EN ISO 10079-2:2014(IDT); ISO 10079-2:2014(IDT)