BAS EN 455-4:2011

Medicinske rukavice za jednokratnu upotrebu - Dio 4: Zahtjevi i ispitivanje za određivanje roka trajanja


Opšte informacije
Status: Važeći
Broj strana: 19
Jezik: Engleski
Izdanje: 1.
Metoda usvajanja: Proglašavanje
Datum objave: 12.05.2011
Tehnički komitet:
Direktiva:
93/42/EEC, Medicinska sredstva
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Apstrakt
for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

Životni ciklus
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Izvorni dokument i stepen usklađenosti
  • EN 455-4:2009, identičan