EN ISO 8871-3:2004
Current
The latest, up-to-date edition.
Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)
26-05-2004
Foreword
Introduction
1 Scope
2 Normative references
3 Determination of visible-particle count
4 Determination of subvisible-particle count
Bibliography
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.
| Committee |
CEN/TC 205
|
| DevelopmentNote |
Supersedes EN ISO 8871. (06/2004)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 8871-3:2003 | Identical |
| NEN EN ISO 8871-3 : 2004 | Identical |
| SN EN ISO 8871-3 : 2004 | Identical |
| NS EN ISO 8871-3 : 1ED 2004 | Identical |
| SS-EN ISO 8871-3:2005 | Identical |
| I.S. EN ISO 8871-3:2004 | Identical |
| NF EN ISO 8871-3:2004 | Identical |
| I.S. EN ISO 8871-3:2004:A1 2019 | Identical |
| UNI EN ISO 8871-3 : 2019 | Identical |
| BS EN ISO 8871-3:2004 | Identical |
| DIN EN ISO 8871-3:2004-09 | Identical |
| UNI EN ISO 8871-3 : 2004 | Identical |
| PN EN ISO 8871-3 : 2005 | Identical |
| UNE-EN ISO 8871-3:2004 | Identical |
| NBN EN ISO 8871-3 : 2004 | Identical |
| ONORM EN ISO 8871-3 : 2004 | Identical |
| NF EN ISO 8871-3 : 2004 AMD 1 2018 | Identical |
| VDI 2083 Blatt 9.2:2017-01 | Cleanroom technology - Consumables in the cleanroom |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
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