I.S. EN ISO 8871-3:2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICALS USE - PART 3: DETERMINATION OF RELEASED-PARTICLE COUNT
Hardcopy , PDF
English
23-07-2004
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.
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.
| Committee |
TC 76
|
| DevelopmentNote |
Supersedes I.S. EN ISO 8871 (08/2004)
|
| DocumentType |
Standard
|
| Pages |
18
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| Standards | Relationship |
| ISO 8871-3:2003 | Identical |
| NEN EN ISO 8871-3 : 2004 | Identical |
| NS EN ISO 8871-3 : 1ED 2004 | Identical |
| BS EN ISO 8871-3:2004 | Identical |
| EN ISO 8871-3:2004 | Identical |
| DIN EN ISO 8871-3:2004-09 | Identical |
| NBN EN ISO 8871-3 : 2004 | Identical |
| ONORM EN ISO 8871-3 : 2004 | Identical |
| UNE-EN ISO 8871-3:2004 | Identical |
| NF EN ISO 8871-3 : 2004 AMD 1 2018 | Identical |
| 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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