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ISO 8871-3:2003

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count
31. 7. 2003.

Опште информације

90.92     27. 5. 2025.

ISO

ISO/TC 76

Međunarodni standard

11.040.20  

engleski   francuski   ruski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 8871:1990

POVUČEN
ISO 8871:1990/Amd 1:1995

TRENUTNO

OBJAVLJEN
ISO 8871-3:2003
90.92 Odluka o izmeni ili reviziji standarda
27. 5. 2025.

ISPRAVKE / IZMENE

OBJAVLJEN
ISO 8871-3:2003/Amd 1:2018

REVIDIRAN OD

PROJEKAT
ISO/AWI 8871-3

Nacionalna preuzimanja

SRPS EN ISO 8871-3:2010  
ISS

Delovi od elastomera za parenteralne preparate i pomoćna sredstva za farmaceutsku upotrebu — Deo 3: Određivanje broja oslobođenih čestica

60.60   Standard objavljen

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