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I.S. EN ISO 8871-1:2004

Current

Current

The latest, up-to-date edition.

ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

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.


Dates of withdrawal of national standards are available from NSAI.

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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