ISO 8871-3:2003
Current
The latest, up-to-date edition.
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
31-07-2003
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 |
ISO/TC 76
|
| DevelopmentNote |
Supersedes ISO/DIS 8871-3 (08/2003) Together with ISO 8871-1, ISO 8871-2, ISO 8871-4 and ISO 8871-5, supersedes ISO 8871. (08/2005)
|
| DocumentType |
Standard
|
| Pages |
6
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| UNI EN ISO 8871-3 : 2019 | Identical |
| BS EN ISO 8871-3:2004 | Identical |
| 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 |
| I.S. EN ISO 8871-3:2004 | Identical |
| NF EN ISO 8871-3:2004 | Identical |
| SN EN ISO 8871-3 : 2004 | Identical |
| NEN EN ISO 8871-3 : 2004 | Identical |
| NS EN ISO 8871-3 : 1ED 2004 | Identical |
| GOST R ISO 8871-3 : 2010 | Identical |
| SS-EN ISO 8871-3:2005 | 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 |
| BS EN ISO 8871-1:2004 | Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates |
| VDI 2083 Blatt 9.2:2017-01 | Cleanroom technology - Consumables in the cleanroom |
| 00/560909 DC : DRAFT MAR 2000 | BS ISO 8871-2 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION |
| ISO 8871-1:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates |
| EN ISO 8871-1:2004 | Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003) |
| 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.