60.60 Standard published Mar 11, 2009
CEN
CEN/TC 215 Respiratory and anaesthetic equipment
European Norm
11.040.10 Anaesthetic, respiratory and reanimation equipment
ISO 23328-2:2002 specifies requirements for non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied. The test method is intended for BSF used with a clinical breathing system.
It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements.
A method for assessing filtration performance of BSF is given in ISO 23328-1.
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WITHDRAWN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 23328-2:2008
PUBLISHED
EN ISO 23328-2:2009
60.60
Standard published
Mar 11, 2009