BS EN 13641:2002 - Elimination or reduction of risk of infection related to in vitro diagnostic reagents

BS EN 13641:2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

Status : Current, Under review   Published : May 2002



This standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is a risk of human infection. The standard does not apply to the following: - instruments and specimen receptacles; NOTE 1 The prevention of infection due to handling of biological materials throughout such equipment is addressed in other relevant International and/or European Standards. - general aspects of workers' protection; - transportation of infectious goods; - disposal measures. NOTE 2 Some of the most relevant documents relating to aspects not covered by this standard are listed in Bibliography for information.

Standard NumberBS EN 13641:2002
TitleElimination or reduction of risk of infection related to in vitro diagnostic reagents
StatusCurrent, Under review
Publication Date27 May 2002
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
International RelationshipsEN 13641:2002
Draft Superseded By99/564177 DC
DescriptorsBiotechnology, Biochemical methods of analysis, Diagnosis (medical), Medical sciences, Biological hazards, Chemical analysis and testing
Title in FrenchElimination ou reduction du risque d'infection relatif aux reactifs de diagnostic in vitro
Title in GermanEliminierung oder Herabsetzung des von Reagenzien f r in-vitro- diagnostische Untersuchungen ausgehenden Infektionsrisikos
ISBN0 580 39780 7
File Size279 KB

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