Podaci o nacrtu

Oznaka:prEN 868-10
Ustanova izvornika:CEN
Odbor:HZN/TO 555
Ime odbora:Medicinski proizvodi
Nacrt objavljen za komentiranje:2017-08-14
Rok za komentiranje:2017-09-26
Broj komentara:0
Contact email:danijela.novota.krajnovic(at)hzn.hr
Područje primjene nacrta:

This European Standard specifies test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868‑9 used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

Other than the general requirements as specified in EN ISO 11607‑1 and EN ISO 11607‑2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard.

The materials specified in this part of EN 868 are intended for single use only.

Secretary remark (to be deleted by formal vote stage): CEN/TC 102/WG 4 proposes to change the Scope of the work item in order to align the scope with the recently published new editions of EN 868‑2, −3, 4- −6 and −7. Please consider that a positive ballot on prEN 858‑10 during enquiry includes the approval of the revised scope.

Sustav komentiranja nacrta norma – Sufinancirale Europska unija i EFTA    

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