SS-EN-ISO-23747 › Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)
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This International Standard specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans.This International Standard covers all medical devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function medical device or as a stand-alone medical device.Planning and design of products applying to this International Standard are to consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex E.NOTE Additional aspects of environmental impact are addressed in ISO 14971.
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11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)
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 23747:2015
Revision Level
2015 EDITION
Status
Current
Publication Date
Aug. 23, 2015
Language(s)
English
Page Count
44
International Equivalent
EN ISO 23747:2015(IDT); ISO 23747:2015(IDT)