60.60 Standard published Aug 19, 2015
CEN
CEN/TC 215 Respiratory and anaesthetic equipment
European Norm
11.040.10 Anaesthetic, respiratory and reanimation equipment
ISO 23747:2015 specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans.
ISO 23747:2015 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.
Legislation related to this standard
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
WITHDRAWN
EN ISO 23747:2009
PUBLISHED
EN ISO 23747:2015
60.60
Standard published
Aug 19, 2015