This European 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.
Diese ÖNORM legt Anforderungen fest bezüglich des Designs und der Herstellung, um das Infektionsrisiko durch Reagenzien für in-vitro-diagnostische Untersuchungen einschließlich Reagenzprodukten, Kalibratoren, Kontrollmaterialien und Kits wirksam unter Kontrolle zu halten. Diese ÖNORM gilt für Reagenzien für in-vitro-diagnostische Untersuchungen, die Material menschlichen Ursprungs enthalten. Diese ÖNORM gilt ebenfalls für Reagenzien für in-vitro-diagnostische Untersuchungen, die mittels biotechnologischer Verfahren hergestellte Materialien oder Materialien tierischen Ursprungs enthalten, insbesondere im Hinblick auf relevante Zoonosen, wenn die Ergebnisse einer Risikoanalyse zeigen, dass ein Infektionsrisiko für Menschen besteht.