SK EN ISO 8871-3:2015

Status: Published
Gjuha: English
Faqe: 8
Publikuar: 2015-11-16
Regjistri Kombëtar:
Botim:

Standardet ndërkombëtare që kanë lidhje

This standard is identical to:
EN ISO 8871-3:2004
CEN/TC 205

Çmim: 13 €

Titulli Shqip

Pjesët elastometrike për jashtintestinalet dhe për pajisjet për përdorim farmaceutik - Pjesa 3: Përcaktimi i njehsimit i grimcës së çliruar (ISO 8871-3:2003)

Titulli Anglisht

Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)

Scope Shqip

Asnjë informacion i shtuar.

Scope Anglisht

Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle. Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations. ISO 8871-3:2003 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing. It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.