Standard Swedish standard · SS-EN ISO 8871-3:2005/A1:2019

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)

Status: Valid

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Standard Swedish standard · SS-EN ISO 8871-3:2005/A1:2019

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)
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Scope
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.
This part of ISO 8871 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.

Subjects

Transfusion, infusion and injection equipment (11.040.20)


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Standard Swedish standard · SS-EN ISO 8871-3:2005/A1:2019

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)
Subscribe on standards - Read more Dölj
Price: 636 SEK
standard ikon pdf

PDF

Price: 636 SEK
standard ikon

Paper

Price: 1 017,60 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80010798

Edition: 1

Approved: 4/5/2019

No of pages: 16

Amendment: SS-EN ISO 8871-3:2005