ONORM EN ISO 22442-2 : 2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING (ISO 22442-2:2015)
05-15-2021
01-12-2013
In diesem Teil der ÖNORM EN ISO 22442 werden die Anforderungen an die Kontrollen der Gewinnung (Herkunftsauswahl), Sammlung und Handhabung (einschliesslich Lagerung und Transport) von Tieren und Geweben festgelegt, die eingesetzt werden zur Herstellung von Medizinprodukten, mit Ausnahme von in-vitro- Diagnostika, unter Verwendung von Materialien tierischen Ursprungs. Die Norm behandelt nicht die Verwendung menschliche Gewebe in Medizinprodukten und legt kein Qualitätsmanagementsystem zur Kontrolle aller Produktionsschritte eines Medizinproduktes fest.
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