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)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-14-2019

Publisher

National Standards Authority of Ireland

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.

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.

Committee	TC 76
DocumentType	Standard
Pages	32
ProductNote	The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. CSV VERSION NOW AVAILABLE.
PublisherName	National Standards Authority of Ireland
Status	Current