I.S. EN ISO 8871-1:2004
Current
The latest, up-to-date edition.
ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES
Hardcopy , PDF
English
01-01-2004
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Classification
4 Requirements
5 Sampling
6 Apparatus and reagents
7 Preparation of test solutions
Annex A (normative) Appearance of solution
Annex B (normative) Acidity or alkalinity
Annex C (normative) Absorbance
Annex D (normative) Reducing substances
Annex E (normative) Extractable heavy metals
Annex F (normative) Extractable zinc
Annex G (normative) Extractable ammonia
Annex H (normative) Residue on evaporation
Annex I (normative) Volatile sulfides
Annex J (informative) Conductivity
Annex ZA (normative) Normative references to international
publications with their relevant European
publications
Bibliography
Covers procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.
| DevelopmentNote |
Supersedes I.S. EN ISO 8871 (11/2004)
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| ISO 8871-1:2003 | Identical |
| EN ISO 8871-1:2004 | Identical |
| BS EN ISO 8871-1:2004 | Identical |
| DIN EN ISO 8871-1:2004-11 | Identical |
| UNE-EN ISO 8871-1:2005 | Identical |
| UNI EN ISO 8871-1 : 2006 | Identical |
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