This European Standard specifies requirements related to design and manufacture in order to effectively controlthe risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materialsand kits, hereinafter called IVD reagents.The standard is applicable to in vitro diagnostic reagents containingmaterial of human origin.The standard is also applicable to in vitro diagnostic reagents containing materialsobtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, whenthe results of a risk analysis reveal thatThere is a risk of human infection.The standard does not apply toThe following:一instruments and specimen receptacles;NOTE 1 The prevention of infection due to handling of biological materials throughout such equipment isaddressed in other relevant International and/or European Standards.一general aspects of workers' protection;transportation of infectious goods;一disposal measures.NOTE 2 Some of the most relevant documents relating to aspects not covered byThis standardBibliography for information.are listed in
EN 13641:2002 history
2002EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents