Name: EN ISO 8871-1 : 2004
Brand: CEN

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

Published date

01-09-2004

Publisher

Comite Europeen de Normalisation

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

Describes 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.

Committee	CEN/TC 205
DevelopmentNote	Supersedes EN ISO 8871 (09/2004)
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current
Supersedes	EN ISO 8871:1997/A1:1999

Standards	Relationship
PN EN ISO 8871-1 : 2005	Identical
UNI EN ISO 8871-1 : 2006	Identical
ISO 8871-1:2003	Identical
NF EN ISO 8871-1 : 2005	Identical
UNE-EN ISO 8871-1:2005	Identical
NBN EN ISO 8871-1 : 2004	Identical
SN EN ISO 8871-1 : 2005	Identical
NS EN ISO 8871-1 : 1ED 2004	Identical
I.S. EN ISO 8871-1:2004	Identical
DIN EN ISO 8871-1:2004-11	Identical
BS EN ISO 8871-1:2004	Identical
NEN EN ISO 8871-1 : 2004	Identical

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