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I.S. EN ISO 8871-3:2004:A1 2019
Current
The latest, up-to-date edition.
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Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of releasedparticle count - Amendment 1 (ISO 8871-3:2003/Amd 1:2018)
Hardcopy , PDF
English
14-04-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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.
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