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NA 176

DIN Standards Committee Health Technologies

Abstract

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.

Begin

2025-05-29

WI

00205421

Planned document number

prEN ISO 8871-3 rev

Responsible national committee

NA 176-04-05 AA - Elastomeric pharmaceutical packaging and related components  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

previous edition(s)

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count - Amendment 1 (ISO 8871-3:2003/Amd 1:2018)
2019-03

Order from DIN Media

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particles count (ISO 8871-3:2003)
2004-05

Order from DIN Media